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Sample records for trial comparing uterine

  1. Randomised trial comparing hysterectomy with endometrial ablation for dysfunctional uterine bleeding: psychiatric and psychosocial aspects.

    Science.gov (United States)

    Alexander, D. A.; Naji, A. A.; Pinion, S. B.; Mollison, J.; Kitchener, H. C.; Parkin, D. E.; Abramovich, D. R.; Russell, I. T.

    1996-01-01

    OBJECTIVE: To compare in psychiatric and psychosocial terms the outcome of hysterectomy and endometrial ablation for the treatment of dysfunctional uterine bleeding. DESIGN: Prospective randomised controlled trial. SETTING--Obstetrics and gynaecology department of a large teaching hospital. SUBJECTS: 204 women with dysfunctional bleeding for whom hysterectomy would have been the preferred treatment were recruited over 24 months and randomly allocated to hysterectomy (99 women) or to hysteroscopic surgery (transcervical resection (52 women) or laser ablation (53 women). MAIN OUTCOME MEASURES: Mental state, martial relationship, psychosocial and sexual adjustment in assessments conducted before the operation and one month, six months, and 12 months later. RESULTS: Both treatments significantly reduced the anxiety and depression present before the operation, and there were no differences in mental health between the groups at 12 months. Hysterectomy did not lead to postoperative psychiatric illness. Sexual interest after the operation did not vary with treatment. Overall, 46 out of 185 (25%) women reported a loss sexual interest and 50 out of 185 (27%) reported increased sexual interest. Marital relationships were unaffected by surgery. Personality and duration of dysfunctional uterine bleeding played no significant part in determining outcome. CONCLUSIONS: Hysteroscopic surgery and hysterectomy have a similar effect on psychiatric and psychosocial outcomes. There is no evidence that hysterectomy leads to postoperative psychiatric illness. PMID:8611783

  2. Efficacy and satisfaction rate comparing endometrial ablation by rollerball electrocoagulation to uterine balloon thermal ablation in a randomised controlled trial.

    NARCIS (Netherlands)

    Zon-Rabelink, I.A.A. van; Vleugels, M.P.; Merkus, J.M.W.M.; Graaf, R.M. de

    2004-01-01

    OBJECTIVE: To compare two methods of endometrial ablation, hysteroscopic rollerball electrocoagulation (RBE) and non-hysteroscopic uterine balloon thermal ablation (Thermachoice trade mark ), regarding efficacy for reducing dysfunctional uterine bleeding and patients satisfaction rate. METHODS: A

  3. Comparing focused ultrasound and uterine artery embolization for uterine fibroids – Rationale and Design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial

    Science.gov (United States)

    Bouwsma, Esther V.A.; Hesley, Gina K.; Woodrum, David A.; Weaver, Amy L.; Leppert, Phyllis C.; Peterson, Lisa G.; Stewart, Elizabeth A.

    2011-01-01

    Objective To present the rational, design and methodology of the FIRSTT study (Fibroid Interventions: Reducing Symptoms Today and Tomorrow, NCT00995878, clinicaltrials.gov). Design Randomized Clinical Trial (RCT) Setting Two Academic Medical Centers Patient(s) Premenopausal women with symptomatic uterine fibroids. Intervention(s) Participants are randomized to two FDA-approved minimally invasive treatments for uterine leiomyomas: uterine artery embolization (UAE) and MRI guided focused ultrasound (MRgFUS). Main Outcome Measure(s) The primary endpoint is defined as the need for an additional intervention for fibroid symptoms following treatment. Secondary outcomes consist of group differences in symptom alleviation, recovery trajectory, health related quality of life, impairment of ovarian reserve, treatment complications and the economic impact of these issues. Results The trial is currently in the phase of active recruitment. Conclusions This RCT will provide important evidence-based information for patients and health care providers regarding optimal minimally invasive treatment approach for women with symptomatic uterine leiomyomas. PMID:21794858

  4. Midterm Clinical and First Reproductive Results of a Randomized Controlled Trial Comparing Uterine Fibroid Embolization and Myomectomy

    International Nuclear Information System (INIS)

    Mara, Michal; Maskova, Jana; Fucikova, Zuzana; Kuzel, David; Belsan, Tomas; Sosna, Ondrej

    2008-01-01

    The purpose of this study was to compare the midterm results of a radiological and surgical approach to uterine fibroids. One hundred twenty-one women with reproductive plans who presented with an intramural fibroid(s) larger than 4 cm were randomly selected for either uterine artery embolization (UAE) or myomectomy. We compared the efficacy and safety of the two procedures and their impact on patient fertility. Fifty-eight embolizations and 63 myomectomies (42 laparoscopic, 21 open) were performed. One hundred eighteen patients have finished at least a 12-month follow-up; the mean follow-up in the entire study population was 24.9 months. Embolized patients underwent a significantly shorter procedure and required a shorter hospital stay and recovery period. They also presented with a lower CRP concentration on the second day after the procedure (p < 0.0001 for all parameters). There were no significant differences between the two groups in the rate of technical success, symptomatic effectiveness, postprocedural follicle stimulating hormone levels, number of reinterventions for fibroid recurrence or regrowth, or complication rates. Forty women after myomectomy and 26 after UAE have tried to conceive, and of these we registered 50 gestations in 45 women. There were more pregnancies (33) and labors (19) and fewer abortions (6) after surgery than after embolization (17 pregnancies, 5 labors, 9 abortions) (p < 0.05). Obstetrical and perinatal results were similar in both groups, possibly due to the low number of labors after UAE to date. We conclude that UAE is less invasive and as symptomatically effective and safe as myomectomy, but myomectomy appears to have superior reproductive outcomes in the first 2 years after treatment

  5. Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Glazener, Cathryn; Constable, Lynda; Hemming, Christine; Breeman, Suzanne; Elders, Andrew; Cooper, Kevin; Freeman, Robert; Smith, Anthony R B; Hagen, Suzanne; McDonald, Alison; McPherson, Gladys; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; Goulao, Beatriz; Norrie, John

    2016-09-08

    One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events. VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation

  6. [Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial].

    Science.gov (United States)

    Rozenberg, P; Deruelle, P; Sénat, M-V; Desbrière, R; Winer, N; Simon, E; Ville, Y; Kayem, G; Boutron, I

    2018-04-01

    The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be

  7. Comparative study of vaginal danazol vs diphereline (a synthetic GnRH agonist) in the control of bleeding during hysteroscopic myomectomy in women with abnormal uterine bleeding: a randomized controlled clinical trial.

    Science.gov (United States)

    Sayyah-Melli, M; Bidadi, S; Taghavi, S; Ouladsahebmadarek, E; Jafari-Shobeiri, M; Ghojazadeh, M; Rahmani, V

    2016-01-01

    To compare the usefulness of vaginal danazol and diphereline in the management of intra-operative bleeding during hysteroscopy. Randomized controlled clinical trial. University hospital. One hundred and ninety participants of reproductive age were enrolled for operative hysteroscopy. Thirty women were excluded from the study. One hundred and sixty participants with submucous myomas were allocated at random to receive either vaginal danazol (200mg BID, 30 days before surgery) or intramuscular diphereline (twice with a 28-day interval). Severity of intra-operative bleeding, clarity of the visual field, volume of media, operative time, success rate for completion of operation and postoperative complications. Overall, 145 patients completed the study. In the danazol group, 78.1% of patients experienced no intra-operative uterine bleeding, and 21.9% experienced mild bleeding. In the diphereline group, 19.4% of patients experienced no intra-operative uterine bleeding, but mild, moderate and severe bleeding was observed in 31.9%, 45.8% and 2.8% of patients, respectively. The difference between the groups was significant (puterine bleeding during operative hysteroscopy. However, vaginal danazol provided a clearer visual field. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  8. Uterine Artery Embolization Versus Laparoscopic Uterine Artery Occlusion: The Outcomes of a Prospective, Nonrandomized Clinical Trial

    International Nuclear Information System (INIS)

    Mara, Michal; Kubinova, Kristyna; Maskova, Jana; Horak, Petr; Belsan, Tomas; Kuzel, David

    2012-01-01

    Purpose: To compare outcomes of two different types of occlusive therapy of uterine fibroids. Methods: Women with fibroid(s) unsuitable for laparoscopic myomectomy (LM) were treated with uterine artery embolization (UAE) or laparoscopic uterine artery occlusion (LUAO). Results: Before the procedure, patients treated with UAE (n = 100) had a dominant fibroid greater in size (68 vs. 48 mm) and a mean age lower (33.1 vs. 34.9 years) than surgically treated patients (n = 100). After 6 months, mean shrinkage of fibroid volume was 53 % after UAE and 39 % after LUAO (p = 0.063); 82 % of women after UAE, but only 23 % after LUAO, had complete myoma infarction (p = 0.001). Women treated with UAE had more complications (31 vs. 11 cases, p = 0.006) and greater incidence of hysteroscopically verified intrauterine necrosis (31 vs. 3 %, p = 0.001). Both groups were comparable in markers of ovarian functions and number of nonelective reinterventions. The groups did not differ in pregnancy (69 % after UAE vs. 67 % after LUAO), delivery (50 vs. 46 %), or abortion (34 vs. 33 %) rates. The mean birth weight of neonates was greater (3270 vs. 2768 g, p = 0.013) and the incidence of intrauterine growth restriction lower (13 vs. 38 %, p = 0.046) in post-UAE patients. Conclusion: Both methods are effective in the treatment of women with future reproductive plans and fibroids not suitable for LM. UAE is more effective in causing complete ischemia of fibroids, but it is associated with greater risk of intrauterine necrosis. Both methods have low rate of serious complications (except for a high abortion rate).

  9. Uterine Artery Embolization Versus Laparoscopic Uterine Artery Occlusion: The Outcomes of a Prospective, Nonrandomized Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Mara, Michal; Kubinova, Kristyna, E-mail: kristyna.kubinova@gmail.com [General Faculty Hospital and 1st Medical Faculty of Charles University, Department of Obstetrics and Gynecology (Czech Republic); Maskova, Jana [Aberdeen Royal Infirmary, Department of Radiology (United Kingdom); Horak, Petr [General Faculty Hospital and 1st Medical Faculty of Charles University, Department of Obstetrics and Gynecology (Czech Republic); Belsan, Tomas [Central Military Hospital, Department of Radiology (Czech Republic); Kuzel, David [General Faculty Hospital and 1st Medical Faculty of Charles University, Department of Obstetrics and Gynecology (Czech Republic)

    2012-10-15

    Purpose: To compare outcomes of two different types of occlusive therapy of uterine fibroids. Methods: Women with fibroid(s) unsuitable for laparoscopic myomectomy (LM) were treated with uterine artery embolization (UAE) or laparoscopic uterine artery occlusion (LUAO). Results: Before the procedure, patients treated with UAE (n = 100) had a dominant fibroid greater in size (68 vs. 48 mm) and a mean age lower (33.1 vs. 34.9 years) than surgically treated patients (n = 100). After 6 months, mean shrinkage of fibroid volume was 53 % after UAE and 39 % after LUAO (p = 0.063); 82 % of women after UAE, but only 23 % after LUAO, had complete myoma infarction (p = 0.001). Women treated with UAE had more complications (31 vs. 11 cases, p = 0.006) and greater incidence of hysteroscopically verified intrauterine necrosis (31 vs. 3 %, p = 0.001). Both groups were comparable in markers of ovarian functions and number of nonelective reinterventions. The groups did not differ in pregnancy (69 % after UAE vs. 67 % after LUAO), delivery (50 vs. 46 %), or abortion (34 vs. 33 %) rates. The mean birth weight of neonates was greater (3270 vs. 2768 g, p = 0.013) and the incidence of intrauterine growth restriction lower (13 vs. 38 %, p = 0.046) in post-UAE patients. Conclusion: Both methods are effective in the treatment of women with future reproductive plans and fibroids not suitable for LM. UAE is more effective in causing complete ischemia of fibroids, but it is associated with greater risk of intrauterine necrosis. Both methods have low rate of serious complications (except for a high abortion rate).

  10. Uterine leiomyoma: comparative study with MRI and histopathology

    International Nuclear Information System (INIS)

    Zhang Rong; Liang Biling; Fu Jiaping; Li Yong; Shen Jun

    2003-01-01

    Objective: To compare MRI findings of uterine leiomyomas with histologic subtypes, and to evaluate the value of enhanced MRI in differentiating leiomyoma subtypes. Methods: Forty-two cases of uterine leiomyomas with MRI and pathology were analyzed between 1998 and 2002. 101 uterine leiomyomas were analyzed. 34 cases were examined with Philips T5-II super-conducting magnetic resonance system (0.5T) using surface coil and 8 cases with Philips Intera 1.5 T super-conducting magnetic resonance system using body phase array coil. Plain scan were acquired with SE T 1 -weighted imaging and TSE T 2 -weighted imaging. Conventional contrast imaging was obtained with SE T 1 -weighted imaging after iv injection of Gd-DTPA (0.1mmol/kg). MR features were observed and compared with that of the pathological types. Results: Almost all the leiomyomas showed slight hypointensity or isointensity on T 1 -weighted images. Most ordinary (97%) leiomyomas displayed hypointensity on T 2 -weighted images. Most cellular (75%) and degenerated (55%) leiomyomas manifested as hyperintensity on T 2 -weighted images. The signal intensity was not statistically different between cellular leiomyomas and degenerated leiomyomas (χ 2 =4.192, P>0.05). However, there was a statistically significant difference in the signal intensity on T 2 -weighted images between ordinary leiomyomas and cellular or degenerated leiomyomas (χ 2 =81.564, P<0.05). The signal homogeneity was statistically different in leiomyomas among different pathological types. Three patterns of enhancement occurred in ordinary leiomyomas, but mostly showed homogeneously enhanced. Most cellular leiomyomas showed homogenous enhancement, the degenerated leiomyomas mostly displayed peripheral and mild enhancement. Conclusion: The signal intensity on MR imaging was different in leiomyomas with different pathological subtype. The Gd-DTPA enhanced scans was not indispensable for the diagnosis and detection of leiomyomas, but it can help to

  11. A randomized clinical trial of knotless barbed suture vs conventional suture for closure of the uterine incision at cesarean delivery.

    Science.gov (United States)

    Peleg, David; Ahmad, Ronan Said; Warsof, Steven L; Marcus-Braun, Naama; Sciaky-Tamir, Yael; Ben Shachar, Inbar

    2018-03-01

    Knotless barbed sutures are monofilament sutures with barbs cut into them. These sutures self-anchor, maintaining tissue approximation without the need for surgical knots. The hypothesis of this study was that knotless barbed suture could be used on the myometrium to close the hysterotomy at cesarean delivery. The objective was to compare uterine closure time, need for additional sutures, and blood loss between this and a conventional suture. This was a prospective, unblinded, randomized controlled trial conducted at the Ziv Medical Center, Zefat, Israel. The primary outcome was the length of time needed to close the uterine incision, which was measured from the start of the first suture on the uterus until obtaining uterine hemostasis. To minimize provider bias, women were randomized by sealed envelopes that were opened in the operating room just prior to uterine closure with either a bidirectional knotless barbed suture or conventional suture. Secondary outcomes included the number of additional hemostatic sutures needed and blood loss during incision closure. Patients were enrolled from August 2016 until March 2017. One hundred two women were randomized. Fifty-one had uterine closure with knotless barbed suture and 51 with conventional suture. The groups were similar for demographics as well as number of previous cesarean deliveries. Uterine closure time using the knotless barbed suture was significantly shorter than the conventional suture by a mean of 1 minute 43 seconds (P barbed sutures were associated with a lower need for hemostatic sutures (median 0 vs 1, P barbed suture is a reasonable alternative to conventional sutures because it reduced the closure time of the uterine incision. There was also less need for additional hemostatic sutures and slightly reduced estimated blood loss. Copyright © 2018 Elsevier Inc. All rights reserved.

  12. A randomised controlled trial of Outpatient versus inpatient Polyp Treatment (OPT) for abnormal uterine bleeding.

    Science.gov (United States)

    Clark, T Justin; Middleton, Lee J; Cooper, Natalie Am; Diwakar, Lavanya; Denny, Elaine; Smith, Paul; Gennard, Laura; Stobert, Lynda; Roberts, Tracy E; Cheed, Versha; Bingham, Tracey; Jowett, Sue; Brettell, Elizabeth; Connor, Mary; Jones, Sian E; Daniels, Jane P

    2015-07-01

    Uterine polyps cause abnormal bleeding in women and conventional practice is to remove them in hospital under general anaesthetic. Advances in technology make it possible to perform polypectomy in an outpatient setting, yet evidence of effectiveness is limited. To test the hypothesis that in women with abnormal uterine bleeding (AUB) associated with benign uterine polyp(s), outpatient polyp treatment achieved as good, or no more than 25% worse, alleviation of bleeding symptoms at 6 months compared with standard inpatient treatment. The hypothesis that response to uterine polyp treatment differed according to the pattern of AUB, menopausal status and longer-term follow-up was tested. The cost-effectiveness and acceptability of outpatient polypectomy was examined. A multicentre, non-inferiority, randomised controlled trial, incorporating a cost-effectiveness analysis and supplemented by a parallel patient preference study. Patient acceptability was evaluated by interview in a qualitative study. Outpatient hysteroscopy clinics and inpatient gynaecology departments within UK NHS hospitals. Women with AUB - defined as heavy menstrual bleeding (formerly known as menorrhagia) (HMB), intermenstrual bleeding or postmenopausal bleeding - and hysteroscopically diagnosed uterine polyps. We randomly assigned 507 women, using a minimisation algorithm, to outpatient polypectomy compared with conventional inpatient polypectomy as a day case in hospital under general anaesthesia. The primary outcome was successful treatment at 6 months, determined by the woman's assessment of her bleeding. Secondary outcomes included quality of life, procedure feasibility, acceptability and cost per quality-adjusted life-year (QALY) gained. At 6 months, 73% (166/228) of women who underwent outpatient polypectomy were successfully treated compared with 80% (168/211) following inpatient polypectomy [relative risk (RR) 0.91, 95% confidence interval (CI) 0.82 to 1.02]. The lower end of the CIs showed

  13. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity....... In order to overcome these various types of heterogeneity and to compare like with like, the treatment comparison should be stratified a posteriori by question (i.e., type of castration or type of anti-androgen studied) and by study. In this way, one may draw valid conclusions. Of course, those trials...

  14. Endometrial ablation by rollerball electrocoagulation compared to uterine balloon thermal ablation. Technical and safety aspects.

    NARCIS (Netherlands)

    Zon-Rabelink, I.A.A. van; Vleugels, M.P.; Merkus, J.M.W.M.; Graaf, R.M. de

    2003-01-01

    OBJECTIVE: To compare two methods of endometrial ablation, hysteroscopic rollerball electrocoagulation (RBE) and non-hysteroscopic uterine balloon thermal (UBT) ablation (Thermachoice), regarding intra- and post-operative technical complications and safety aspects. STUDY DESIGN: A randomised

  15. Nifedipine as a uterine relaxant for external cephalic version: a randomized controlled trial

    NARCIS (Netherlands)

    Kok, Marjolein; Bais, Joke M.; van Lith, Jan M.; Papatsonis, Dimitri M.; Kleiverda, Gunilla; Hanny, Dahrs; Doornbos, Johannes P.; Mol, Ben W.; van der Post, Joris A.

    2008-01-01

    OBJECTIVE: To estimate the effectiveness of nifedipine as a uterine relaxant during external cephalic version to correct breech presentation. METHODS: In this randomized, double-blind, placebo-controlled trial, women with a singleton fetus in breech presentation and a gestational age of 36 weeks or

  16. Atosiban versus fenoterol as a uterine relaxant for external cephalic version: randomised controlled trial.

    Science.gov (United States)

    Velzel, Joost; Vlemmix, Floortje; Opmeer, Brent C; Molkenboer, Jan F M; Verhoeven, Corine J; van Pampus, Mariëlle G; Papatsonis, Dimitri N M; Bais, Joke M J; Vollebregt, Karlijn C; van der Esch, Liesbeth; Van der Post, Joris A M; Mol, Ben Willem; Kok, Marjolein

    2017-01-26

     To compare the effectiveness of the oxytocin receptor antagonist atosiban with the beta mimetic fenoterol as uterine relaxants in women undergoing external cephalic version (ECV) for breech presentation.  Multicentre, open label, randomised controlled trial.  Eight hospitals in the Netherlands, August 2009 to May 2014.  830 women with a singleton fetus in breech presentation and a gestational age of more than 34 weeks were randomly allocated in a 1:1 ratio to either 6.75 mg atosiban (n=416) or 40 μg fenoterol (n=414) intravenously for uterine relaxation before ECV.  The primary outcome measures were a fetus in cephalic position 30 minutes after the procedure and cephalic presentation at delivery. Secondary outcome measures were mode of delivery, incidence of fetal and maternal complications, and drug related adverse events. All analyses were done on an intention-to-treat basis.  Cephalic position 30 minutes after ECV occurred significantly less in the atosiban group than in the fenoterol group (34% v 40%, relative risk 0.73, 95% confidence interval 0.55 to 0.93). Presentation at birth was cephalic in 35% (n=139) of the atosiban group and 40% (n=166) of the fenoterol group (0.86, 0.72 to 1.03), and caesarean delivery was performed in 60% (n=240) of women in the atosiban group and 55% (n=218) in the fenoterol group (1.09, 0.96 to 1.20). No significant differences were found in neonatal outcomes or drug related adverse events.  In women undergoing ECV for breech presentation, uterine relaxation with fenoterol increases the rate of cephalic presentation 30 minutes after the procedure. No statistically significant difference was found for cephalic presentation at delivery.  Dutch Trial Register, NTR 1877. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  17. The Comparing Options for Management: Patient-centered Results for Uterine Fibroids (COMPARE-UF) Registry: Rationale and Design.

    Science.gov (United States)

    Stewart, Elizabeth A; Lytle, Barbara L; Thomas, Laine; Wegienka, Ganesa R; Jacoby, Vanessa; Diamond, Michael P; Nicholson, Wanda K; Anchan, Raymond M; Venable, Sateria; Wallace, Kedra; Marsh, Erica E; Maxwell, George L; Borah, Bijan J; Catherino, William H; Myers, Evan R

    2018-05-08

    To design and establish a uterine fibroid (UF) registry based in the United States (US) to provide comparative effectiveness data regarding UF treatment. We report here the design and initial recruitment for the Comparing Options for Management: Patient-centered Results for Uterine Fibroids (COMPARE-UF) registry (Clinicaltrials.gov, NCT02260752), funded by the Agency for Healthcare Research and Quality (AHRQ) in collaboration with the-Patient-Centered Outcomes Research Institute (PCORI). COMPARE-UF is designed to help answer critical questions about treatment options for women with symptomatic UF. Women undergoing a procedure for UF (hysterectomy, myomectomy [abdominal, hysteroscopic, vaginal and laparoscopic/robotic], endometrial ablation, radiofrequency fibroid ablation, uterine artery embolization, magnetic resonance guided focused ultrasound or progestin-releasing intrauterine device insertion) at one of the COMPARE-UF sites are invited to participate in a prospective registry with three years follow-up for post-procedural outcomes. Enrolled participants provide annual follow-up through an online portal or through traditional phone contact. A central data abstraction center provides information obtained from imaging, operative or procedural notes and pathology reports. Women with uterine fibroids and other stakeholders are a key part of the COMPARE-UF registry and participate at all points from study design to dissemination of results. We built a network of nine clinical sites across the US with expertise in the care of women with UF to capture geographic, racial, ethnic and procedural diversity. Of the initial 2031 women enrolled in COMPARE-UF, 42% are self-identified as Black or African-American and 40% are age 40 years or younger with 16% of participants under age 35. Women undergoing myomectomy comprise the largest treatment group at 46% of all procedures with laparoscopic or robotic myomectomy comprising the largest subset of myomectomies at 19% of all

  18. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  19. Comparative study between the hysteroscopic and histological diagnosis of patients with abnormal uterine bleeding during menacme

    Directory of Open Access Journals (Sweden)

    Reginaldo Guedes Coelho Lopes

    2006-09-01

    Full Text Available Objective: The objective of this research was to evaluate the feasibilityand the diagnostic properties of hysteroscopy in a population of womenduring menacme with the complaint of abnormal uterine bleeding,comparing endoscopic with histological findings. Methods: The studywas retrospectively conducted in 314 outpatients submitted tohysteroscopy. Every woman was submitted to guided endometrialbiopsy, using a 3 or 5mm-diameter Novak curette. The hysteroscopesused were of 3 or 5mm caliber which image was reproduced in ascreen by means of an endocamera. The results of hysteroscopic andhistological exams were compared. Results: There were noabnormalities of the uterine cavity in 151 patients (48%. Submucousmyoma was the most frequent alteration found in 45 women (14.3%.Malignancy was detected in nine patients, out of which seven hadhistological confirmation. Sensibility and specificity of hysteroscopywere respectively: a 86.3% and 75.9% for abnormal uterine cavity; b100% and 99.4% for malignancy, and c 57.7% and 88.5% for endometrialhyperplasia. Five patients (6.6% were not submitted to hysteroscopydue to cervical stenosis. Two percent of the cases presented vagalreactions, such as sweating, nausea and dizziness, with short-timerecovery. Conclusions: For higher sensitivity and specificity, diagnostichysteroscopy should be complemented with histology of theendometrial biopsy. This procedure should be considered in the workupof patients at menacme with complaints of abnormal uterinebleeding.

  20. Impact of adding a second-layer to a single unlocked closure of Cesarean uterine incision: a randomized controlled trial

    DEFF Research Database (Denmark)

    Rudnicki, Martin; Bennich, G; Wilken-Jensen, C

    2016-01-01

    the criteria and accepted participation. Thirty-eight women were assigned to single-layer and 38 to double-layer unlocked closure technique. Groups were comparable regarding gestational age at delivery, duration of surgery and peroperative blood loss. RMT was without difference between the two groups, both......The purpose of the present study was to investigate short- and long term effects on residual myometrial thickness (RMT) by adding a second-layer to a single unlocked closure of caesarean uterine incision. METHOD: he study was a randomized double-blind controlled trial. Healthy nulliparous scheduled...... for first-time elective Caesarean delivery were operated using a modified version of the Misgav-Ladach surgical technique. The women were examined by abdominal ultrasound before discharge from the maternity ward and by hysterosonography five months post partum. RESULTS: Seventy-six nulliparous met...

  1. Hysteroscopic Endometrial Resection Versus Laparoscopic Supracervical Hysterectomy for Abnormal Uterine Bleeding: Long-term Follow-up of a Randomized Trial.

    Science.gov (United States)

    Zupi, Errico; Centini, Gabriele; Lazzeri, Lucia; Finco, Andrea; Exacoustos, Caterina; Afors, Karolina; Zullo, Fulvio; Petraglia, Felice

    2015-01-01

    To compare long-term efficacy of laparoscopic supracervical hysterectomy (LSH) and hysteroscopic endometrial ablation (HEA) in treating persistent abnormal uterine bleeding. Canadian Task Force II-2. University hospital. One hundred fifty-three women treated for abnormal uterine bleeding by LSH or HEA. Long-term follow-up assessment of reintervention rate and quality of life (QoL) using the Quality Metric's Health Survey Short Form 12. This study is the long-term follow-up of a randomized control trial conducted in 2003 comparing LSH and HEA in terms of reoperation rate and QoL. Starting from November 2010 all patients included in the first trial were invited to participate in this study and clinically evaluated through vaginal examination and transvaginal ultrasound. After a mean follow-up of 14.4 years, 29% of patients (20/71) treated with HEA underwent further surgery, whereas no patients after LSH had symptom recurrence. The reintervention rate was significantly higher in the HEA group (p abnormal uterine bleeding when compared with HEA. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.

  2. Single versus double-layer uterine closure at cesarean: impact on lower uterine segment thickness at next pregnancy.

    Science.gov (United States)

    Vachon-Marceau, Chantale; Demers, Suzanne; Bujold, Emmanuel; Roberge, Stephanie; Gauthier, Robert J; Pasquier, Jean-Charles; Girard, Mario; Chaillet, Nils; Boulvain, Michel; Jastrow, Nicole

    2017-07-01

    Uterine rupture is a potential life-threatening complication during a trial of labor after cesarean delivery. Single-layer closure of the uterus at cesarean delivery has been associated with an increased risk of uterine rupture compared with double-layer closure. Lower uterine segment thickness measurement by ultrasound has been used to evaluate the quality of the uterine scar after cesarean delivery and is associated with the risk of uterine rupture. To estimate the impact of previous uterine closure on lower uterine segment thickness. Women with a previous single low-transverse cesarean delivery were recruited at 34-38 weeks' gestation. Transabdominal and transvaginal ultrasound evaluation of the lower uterine segment thickness was performed by a sonographer blinded to clinical data. Previous operative reports were reviewed to obtain the type of previous uterine closure. Third-trimester lower uterine segment thickness at the next pregnancy was compared according to the number of layers sutured and according to the type of thread for uterine closure, using weighted mean differences and multivariate logistic regression analyses. Of 1613 women recruited, with operative reports available, 495 (31%) had a single-layer and 1118 (69%) had a double-layer closure. The mean third-trimester lower uterine segment thickness was 3.3 ± 1.3 mm and the proportion with lower uterine segment thickness cesarean delivery is associated with a thicker third-trimester lower uterine segment and a reduced risk of lower uterine segment thickness <2.0 mm in the next pregnancy. The type of thread for uterine closure has no significant impact on lower uterine segment thickness. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Randomized Comparison of Uterine Artery Embolization (UAE) with Surgical Treatment in Patients with Symptomatic Uterine Fibroids (REST Trial): Subanalysis of 5-Year MRI Findings

    Energy Technology Data Exchange (ETDEWEB)

    Ananthakrishnan, Ganapathy, E-mail: ganapathy.ananthakrishnan@nhs.net [Gartnavel General Hospital, Department of Interventional Radiology (United Kingdom); Murray, Lilian, E-mail: Lilian.murray@glasgow.ac.uk [Vital Statistics (United Kingdom); Ritchie, Moira, E-mail: moira.ritchie@ggc.scot.nhs.uk [Gartnavel General Hospital, Department of Interventional Radiology (United Kingdom); Murray, Gordon, E-mail: Gordon.murray@ed.ac.uk [Centre for Population Health Sciences, University of Edinburgh, Department of Medical Statistics (United Kingdom); Bryden, Fiona, E-mail: Fiona.bryden@ggc.scot.nhs.uk [Stobhill Hospital (United Kingdom); Lassman, Sue, E-mail: sue.lassman@ggc.scot.nhs.uk [Gartnavel General Hospital, Department of Interventional Radiology (United Kingdom); Lumsden, Mary Ann, E-mail: Maryann.lumsden@glasgow.ac.uk [Room 12, Level 4, Walton Building, Department of Medical Education and Gynaecology, Reproductive and Maternal Medicine (United Kingdom); Moss, Jon G., E-mail: jon.moss@ggc.scot.nhs.uk [Gartnavel General Hospital, Department of Interventional Radiology (United Kingdom)

    2013-06-15

    Purpose. To report 5-year contrast-enhanced magnetic resonance imaging findings of the REST trial recruits who underwent either uterine artery embolization (UAE) or myomectomy. Methods. A total of 157 patients were randomized to UAE or surgery (hysterectomy or myomectomy). Ninety-nine patients who had UAE and eight patients who had myomectomy were analyzed. MRI scans at baseline, 6 months, and 5 years were independently interpreted by two radiologists. Dominant fibroid diameter, uterine volume, total fibroid infarction (complete 100 %, almost complete 90-99 %, partial <90 %), and new fibroid formation were the main parameters assessed and related to the need for reintervention. Results. In the UAE group, mean {+-} standard deviation uterine volume was 670 {+-} 503, 422 {+-} 353, and 292 {+-} 287 mL at baseline, 6 months, and 5 years, respectively. Mean dominant fibroid diameter was 7.6 {+-} 3.0, 5.8 {+-} 2.9, and 5 {+-} 2.9 cm at baseline, 6 months, and 5 years. Fibroid infarction at 6 months was complete in 35 % of women, almost complete in 29 %, and partial in 36 %. Need for reintervention was 19, 10, and 33 % in these groups, respectively (p = 0.123). No myomectomy cases had further intervention. At 5 years, the prevalence of new fibroid was 60 % in the myomectomy group and 7 % in the UAE group (p = 0.008). Conclusion. There is a further significant reduction in both uterine volume and dominant fibroid diameter between 6 months and 5 years after UAE. Complete fibroid infarction does not translate into total freedom from a subsequent reintervention. New fibroid formation is significantly higher after myomectomy.

  4. [Research of gestrinone-related abnormal uterine bleeding and the intervention in the treatment: a multi-center, randomized, controlled clinical trial].

    Science.gov (United States)

    Duan, H; Wang, S; Hao, M; Chen, L; Tang, J; Wang, X; Peng, Y Z; Zhang, S C; Cao, L R; Yu, J J

    2016-02-01

    To investigate the incidence, influencing factors and intervention of gestrinone-related abnormal uterine bleeding at different dosage of gestrinone in the clinical treatment. This was a multicenter, randomized, control study of 195 Chinese women with endometriosis or adenomyosis from June 2011 to November 2013. The subjects were randomized into three groups with oral administration of gestrinone, 2.5 mg dose at one time; twice a week group: 67 cases with oral administration twice a week last three months; double dose first month group: 67 cases with oral administration triple times a week at first month, then twice a week for two months; three times a week group: 61 cases with oral administration three times a week last three months. The improvement of the abnormal uterine bleeding, the changes in estrogen, liver function and blood coagulation were evaluated. At the same time, B-ultrasound examination evaluation were performed. (1) Three months later, the incidence of abnormal uterine bleeding in twice a week group was 30% (20/67), in double dose first month group and three times a week group were 7%(5/67) and 16% (10/61) respectively, there were significant difference between three groups (Pabnormal uterine bleeding (OR=0.461,P= 0.003;OR=0.303,P=0.016); logistic regression analysis demonstrated that the risk of abnormal uterine bleeding in double dose first month group was the lowest when compared with twice a week group and three times a week group, the risk in twice a week group was 5-fold higher than that in double dose first month group (OR=0.211,P=0.011). The incidence of abnormal uterine bleeding in participants with abnormal ovarian volume results from ovarian cyst or ovarian surgery was significantly lower than those with normal ovarian volume (OR=0.304,P=0.018). (3) After the treatment of three months, there were no significant difference in alanine transaminase level between the groups (P>0.05). The body mass index significantly increased in three group

  5. Embolization therapy of uterine fibroids by using pingyangmycin lipiodol emulsion or polyvinyl alcohol particles: a clinical comparative study

    International Nuclear Information System (INIS)

    Zhang Dazhong; Yin Jianlin; Liu Hairi; Zhang Fuqiang; Huang Hai; Gu Youmei

    2010-01-01

    Objective: To evaluate the efficacy and safety of embolization of uterine fibroids by using pingyangmycin lipiodol emulsion or polyvinyl alcohol particles as embolismic materials. Methods: Seventy-three patients with uterine fibroids were divided into two groups. Patients in group A (29 cases) were treated with pingyangmycin lipiodol emulsion as embolismic materials, while patients in group B (44 cases) with polyvinyl alcohol particles (with a diameter of 300-700 μm) as embolismic materials. Embolization therapy of uterine fibroids was performed in all patients. The uterus volume, the size of uterine fibroid and sex hormone level both before and after the treatment were estimated and the results were compared between two groups. The occurrence of complications was observed. Results: The technical success of catheterization and embolization was 100% in both groups. After the therapy,both the uterus volume and the uterine fibroid size decreased significantly, but no significant difference in the size reduction existed between the two groups (P>0.05). The clinical symptoms showed a marked improvement in all patients, while the sex hormone level showed no obvious changes. No serious complications occurred. Conclusion: In treating uterine fibroids with embolization technique, both pingyangmycin lipiodol emulsion and polyvinyl alcohol particles are safe and effective embolismic materials. However, use of polyvinyl alcohol particles may be safer than pingyangmycin, as pingyangmycin is a kind of chemotherapeutic drugs, which might potentially cause some short-term or long-term complications. (authors)

  6. Economic evaluation of uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids: results from the randomized EMMY trial.

    Science.gov (United States)

    Volkers, Nicole A; Hehenkamp, Wouter J K; Smit, Patrick; Ankum, Willem M; Reekers, Jim A; Birnie, Erwin

    2008-07-01

    To investigate whether uterine artery embolization (UAE) is a cost-effective alternative to hysterectomy for patients with symptomatic uterine fibroids, the authors performed an economic evaluation alongside the multicenter randomized EMMY (EMbolization versus hysterectoMY) trial. Between February 2002 and February 2004, 177 patients were randomized to undergo UAE (n = 88) or hysterectomy (n = 89) and followed up until 24 months after initial treatment allocation. Conditional on the equivalence of clinical outcome, a cost minimization analysis was performed according to the intention to treat principle. Costs included health care costs inside and outside the hospital as well as costs related to absence from work (societal perspective). Cumulative standardized costs were estimated as volumes multiplied with prices. The nonparametric bootstrap method was used to quantify differences in mean (95% confidence interval [CI]) costs between the strategies. In total, 81 patients underwent UAE and 75 underwent hysterectomy. In the UAE group, 19 patients (23%) underwent secondary hysterectomies. The mean total costs per patient in the UAE group were significantly lower than those in the hysterectomy group ($11,626 vs $18,563; mean difference, -$6,936 [-37%], 95% CI: -$9,548, $4,281). The direct medical in-hospital costs were significantly lower in the UAE group: $6,688 vs $8,313 (mean difference, -$1,624 [-20%], 95% CI: -$2,605, -$586). Direct medical out-of-hospital and direct nonmedical costs were low in both groups (mean cost difference, $156 in favor of hysterectomy). The costs related to absence from work differed significantly between the treatment strategies in favor of UAE (mean difference, -$5,453; 95% CI: -$7,718, -$3,107). The costs of absence from work accounted for 79% of the difference in total costs. The 24-month cumulative cost of UAE is lower than that of hysterectomy. From a societal economic perspective, UAE is the superior treatment strategy in women with

  7. Nifedipine as a uterine relaxant for external cephalic version: a randomized controlled trial.

    Science.gov (United States)

    Kok, Marjolein; Bais, Joke M; van Lith, Jan M; Papatsonis, Dimitri M; Kleiverda, Gunilla; Hanny, Dahrs; Doornbos, Johannes P; Mol, Ben W; van der Post, Joris A

    2008-08-01

    To estimate the effectiveness of nifedipine as a uterine relaxant during external cephalic version to correct breech presentation. In this randomized, double-blind, placebo-controlled trial, women with a singleton fetus in breech presentation and a gestational age of 36 weeks or more were eligible for enrollment. Participating women received two doses of either nifedipine 10 mg or placebo, 30 and 15 minutes before the external cephalic version attempt. The primary outcome was a cephalic-presenting fetus immediately after the procedure. Secondary outcome measures were cephalic presentation at delivery, mode of delivery, and adverse events. A sample size of 292 was calculated to provide 80% power to detect a 17% improvement of the external cephalic version success rate, assuming a placebo group rate of 40% and alpha of .05. Outcome data for 310 of 320 randomly assigned participants revealed no significant difference in external cephalic version success rates between treatment (42%) and control group (37%) (relative risk 1.1, 95%; 95% confidence interval 0.85-1.5). The cesarean delivery rate was 51% in the treatment group and 46% in the control group (relative risk 1.1, 95% confidence interval 0.88-1.4). Nifedipine did not significantly improve the success of external cephalic version. Future use of nifedipine to improve the outcome of external cephalic version should be limited to large clinical trials.

  8. Pain and Return to Daily Activities after Uterine Artery Embolization and Hysterectomy in the Treatment of Symptomatic Uterine Fibroids: Results from the Randomized EMMY Trial

    International Nuclear Information System (INIS)

    Hehenkamp, Wouter J.K.; Volkers, Nicole A.; Birnie, Erwin; Reekers, Jim A.; Ankum, Willem M.

    2006-01-01

    Purpose. To evaluate the safety and efficacy of uterine artery embolization (UAE) and hysterectomy for symptomatic uterine fibroids by means of a randomized controlled trial. The present paper analyses short-term outcomes, i.e., pain and return to daily activities. Methods. Patients were randomized (1:1) to UAE or hysterectomy. Pain was assessed during admission and after discharge, both quantitatively and qualitatively, using a numerical rating scale and questionnaires. Time to return to daily activities was assessed by questionnaire. Results. Seventy-five patients underwent hysterectomy and 81 patients underwent UAE. UAE patients experienced significantly less pain during the first 24 hr after treatment (p = 0.012). Non-white patients had significantly higher pain scores. UAE patients returned significantly sooner to daily activities than hysterectomy patients (for paid work: 28.1 versus 63.4 days; p < 0.001). In conclusion, pain appears to be less after UAE during hospital stay. Return to several daily activities was in favor of UAE in comparison with hysterectomy

  9. Operative technique at caesarean delivery and risk of complete uterine rupture in a subsequent trial of labour at term. A registry case-control study

    DEFF Research Database (Denmark)

    Thisted, Dorthe L. A.; Mortensen, Laust H.; Hvidman, Lone

    2017-01-01

    Objective: To estimate the relation of single-layer closure at previous caesarean delivery, and other pre-labour and intra-partum risk factors for complete uterine rupture in trial of vaginal birth after a caesarean (TOLAC) at term. Study design: Population-based case-control study. We identified...... all women (n = 39 742) recorded in the Danish Medical Birth Registry (DMBR) during a 12-year period (1997–2008) with a singleton pregnancy at term and TOLAC. Among these, all women with a complete uterine rupture were identified (cases). Information from the registry was validated against medical...... of uterine rupture. Conclusion: Single-layer uterine closure did not remain significantly associated to uterine rupture during TOLAC at term after adjustment for confounding factors. Induction of labour with an unfavourable cervix, birth weight ≥ 4000g and indicators of prolonged labour were all major risk...

  10. The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial.

    Science.gov (United States)

    Vervoort, A J M W; Van der Voet, L F; Witmer, M; Thurkow, A L; Radder, C M; van Kesteren, P J M; Quartero, H W P; Kuchenbecker, W K H; Bongers, M Y; Geomini, P M A J; de Vleeschouwer, L H M; van Hooff, M H A; van Vliet, H A A M; Veersema, S; Renes, W B; van Meurs, H S; Bosmans, J; Oude Rengerink, K; Brölmann, H A M; Mol, B W J; Huirne, J A F

    2015-11-12

    A caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection. We planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months. The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation. This trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection. Dutch Trial Register NTR3269 . Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030.

  11. Comparative studies on the increase of uterine weight and related mechanisms of cadmium and p-nonylphenol

    International Nuclear Information System (INIS)

    Zhang Wenchang; Yang Jinsong; Wang Jiali; Xia Pincang; Xu Youqiong; Jia Haimei; Chen Yongshan

    2007-01-01

    The research was designed to compare the effect of cadmium and p-nonylphenol on the increase of uterine weight and to study the related mechanisms. It provided basic evidence for us to understand the possible different mechanisms among different EEDs. In this study, both ovaries of 60 Wistar rats (28 days age) were ectomized, and after 21 days recovery, the rats were randomly assigned into six groups and exposed to cadmium (0.12, 1.20 mg/kg), NP (100, 200 mg/kg), control (sterile PBS), and positive control (17β-estradiol) per day for 3 days, respectively, then related indexes were detected. The results showed that the increase of uterine weight induced by cadmium was accompanied by the increase of the thickness of luminal epithelium cell and endometrium but the decrease of nuclear/cytoplasm of luminal epithelium cell and endometrium, while the increase of uterine weight induced by p-nonylphenol was accompanied by the increase of the thickness of luminal epithelium cell, endometrium, and myometrium but the decrease of nuclear/cytoplasm of luminal epithelium cell and endometrium. Cadmium could inhibit the positive expression of PCNA while p-nonylphenol prompted it. Exposure to cadmium and NP both could also stimulate phosphorylation of ERK mitogen-activated protein kinases, implying that this signal pathway had an effect on the increase of the uterine weight induced by cadmium and p-nonylphenol. The results indicate that cadmium may induce the increase of uterine weight, which is accompanied with toxic effect on endometrium, while NP's effect of the increase of uterine weight is due to cell proliferation of endometrium, the mechanisms of which are the same as estrogen, but they may both activate ERK signal pathway

  12. Diagnostic value of saline contrast sonohysterography comparing with hysteroscopy for detecting endometrial abnormalities in women with abnormal uterine bleeding

    Directory of Open Access Journals (Sweden)

    Farzaneh Goharzad

    2011-01-01

    Full Text Available Background: Abnormal uterine bleeding is a common presentation of uterine abnormalities among premenopausal and postmenopausal women.Objective: To evaluate and compare the diagnostic accuracy of saline contrast sonohysterography and hysteroscopy for detecting the cause of abnormal uterine bleeding.Materials and Methods: A total of 65 women with abnormal uterine bleeding were enrolled in this study. A prior saline contrast sonohysetrography followed by a hysteroscopy was performed in all cases. Sensitivity, specificity, positive and negative predictive value and test accuracy were calculated.Results: As the most common abnormality, SCSH showed hyperplasia in 19 patients while hysteroscopy diagnosed polyp in 15 cases. A sensitivity of 73.3%, 71.4% and 90.9% were reported for polyp, hyperplasia and submucous myoma respectively whereas the specificity was calculated 96% for polyps, 82.3% for hyperplasia and 90.7% for submucous myoma.Conclusion: Comparing with hysteroscopy, sonohysterography showed a high sensitivity and specificity for detecting submucous myoma but not for endometrial polyp and endometrial hyperplasia

  13. Optimal Order of Successive Office Hysteroscopy and Endometrial Biopsy for the Evaluation of Abnormal Uterine Bleeding: A Randomized Controlled Trial.

    Science.gov (United States)

    Sarkar, Papri; Mikhail, Emad; Schickler, Robyn; Plosker, Shayne; Imudia, Anthony N

    2017-09-01

    To estimate the optimal order of office hysteroscopy and endometrial biopsy when performed successively for evaluation of abnormal uterine bleeding. Patients undergoing successive office hysteroscopy and endometrial biopsy were included in a single-blind, prospective, randomized trial. The primary outcome was to evaluate the effect of order of procedures on patients' pain score. Prespecified secondary outcomes include procedure duration, hysteroscopic visualization of the uterine cavity, endometrial sample adequacy, and number of attempts at biopsy. Pain scores were assessed using a visual analog scale from 0 to 10 and endometrial sample adequacy was determined from the histopathology report. Hysteroscopy images were recorded. Sample size of 34 per group (n=68) was determined to be adequate to detect a difference of 20% in visual analog scale score between hysteroscopy first (group A) and biopsy first (group B) at α of 0.05 and 80% power. Between October 2015 and January 2017, 78 women were randomized to group A (n=40) and group B (n=38). There was no difference in global pain perception [7 (0-10) vs 7 (0-10); P=.57, 95% CI 5.8-7.1]. Procedure duration [3 (1-9) vs 3 (2-10), P=.32, 95% CI 3.3-4.1] and endometrial sample adequacy (78.9% vs 75.7%, P=.74) were similar in both groups. Group A patients had better endometrial visualization (Pabnormal uterine bleeding, the global pain perception, and time required are independent of the order in which procedures are performed. Performing hysteroscopy first ensures better image, whereas biopsy first yields adequate tissue sample with fewer attempts. ClinicalTrials.gov, NCT02472184.

  14. Umbilical cord mesenchyme stem cell local intramuscular injection for treatment of uterine niche: Protocol for a prospective, randomized, double-blinded, placebo-controlled clinical trial.

    Science.gov (United States)

    Fan, Dazhi; Wu, Shuzhen; Ye, Shaoxin; Wang, Wen; Guo, Xiaoling; Liu, Zhengping

    2017-11-01

    Uterine niche is defined as a triangular anechoic structure at the site of the scar or a gap in the myometrium at the site of a previous caesarean section. The main clinical manifestations are postmenstrual spotting and intrauterine infection, which may seriously affect the daily life of nonpregnant women. Trials have shown an excellent safety and efficacy for the potential of mesenchymal stem cells (MSCs) as a therapeutic option for scar reconstruction. Therefore, this study is designed to investigate the safety and efficacy of using MSCs in the treatment for the uterine niche. This phase II clinical trial is a single-center, prospective, randomized, double-blind, placebo-controlled with 2 arms. One hundred twenty primiparous participants will be randomly (1:1 ratio) assigned to receive direct intramuscular injection of MSCs (a dose of 1*10 cells in 1 mL of 0.9% saline) (MSCs group) or an identical-appearing 1 mL of 0.9% saline (placebo-controlled group) near the uterine incision. The primary outcome of this trial is to evaluate the proportion of participants at 6 months who is found uterine niche in the uterus by transvaginal utrasonography. Adverse events will be documented in a case report form. The study will be conducted at the Department of Obstetric of Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan. This trial is the first investigation of the potential for therapeutic use of MSCs for the management of uterine niche after cesarean delivery. This protocol will help to determine the efficacy and safety of MSCs treatment in uterine niche and bridge the gap with regards to the current preclinical and clinical evidence. NCT02968459 (Clinical Trials.gov: http://clinicaltrials.gov/).

  15. Abnormal uterine bleeding in VTE patients treated with rivaroxaban compared to vitamin K antagonists

    NARCIS (Netherlands)

    de Crem, Nico; Peerlinck, Kathelijne; Vanassche, Thomas; Vanheule, Kristine; Debaveye, Barbara; Middeldorp, Saskia; Verhamme, Peter; Peetermans, Marijke

    2015-01-01

    Introduction: Rivaroxaban is a convenient oral anticoagulant for patients with venous thromboembolism (VTE). The impact of rivaroxaban and vitamin K antagonists (VKAs) on abnormal uterine bleeding (AUB) in real life has not been previously explored. Materials and methods: We performed a

  16. A Prospective Randomized Clinical Trial of Single vs. Double Layer Closure of Hysterotomy at the Time of Cesarean Delivery: The Effect on Uterine Scar Thickness.

    Science.gov (United States)

    Bamberg, Christian; Dudenhausen, Joachim W; Bujak, Verena; Rodekamp, Elke; Brauer, Martin; Hinkson, Larry; Kalache, Karim; Henrich, Wolfgang

    2018-06-01

     We undertook a randomized clinical trial to examine the outcome of a single vs. a double layer uterine closure using ultrasound to assess uterine scar thickness.  Participating women were allocated to one of three uterotomy suture techniques: continuous single layer unlocked suturing, continuous locked single layer suturing, or double layer suturing. Transvaginal ultrasound of uterine scar thickness was performed 6 weeks and 6 - 24 months after Cesarean delivery. Sonographers were blinded to the closure technique.  An "intent-to-treat" and "as treated" ANOVA analysis included 435 patients (n = 149 single layer unlocked suturing, n = 157 single layer locked suturing, and n = 129 double layer suturing). 6 weeks postpartum, the median scar thickness did not differ among the three groups: 10.0 (8.5 - 12.3 mm) single layer unlocked vs. 10.1 (8.2 - 12.7 mm) single layer locked vs. 10.8 (8.1 - 12.8 mm) double layer; (p = 0.84). At the time of the second follow-up, the uterine scar was not significantly (p = 0.06) thicker if the uterus had been closed with a double layer closure 7.3 (5.7 - 9.1 mm), compared to single layer unlocked 6.4 (5.0 - 8.8 mm) or locked suturing techniques 6.8 (5.2 - 8.7 mm). Women who underwent primary or elective Cesarean delivery showed a significantly (p = 0.03, p = 0.02, "as treated") increased median scar thickness after double layer closure vs. single layer unlocked suture.  A double layer closure of the hysterotomy is associated with a thicker myometrium scar only in primary or elective Cesarean delivery patients. © Georg Thieme Verlag KG Stuttgart · New York.

  17. A comparison between electrical uterine monitor, tocodynamometer and intra uterine pressure catheter for uterine activity in labor.

    Science.gov (United States)

    Hadar, Eran; Biron-Shental, Tal; Gavish, Oz; Raban, Oded; Yogev, Yariv

    2015-08-01

    We aimed to evaluate the performance of a non-invasive EMG electrical uterine monitor (EUM) versus tocodynamometry (TOCO) by comparing both to internal uterine pressure catheter (IUPC). Prospective observational trial. Uterine activity was recorded continuously and simultaneously, in women during active term labor, with TOCO, EUM and IUPC. Uterine activity tracings were analyzed by three blinded physicians. Overall, 385 tracings from 43 women were analyzed. A similar rate of interpretable tracings between physicians was demonstrated for EUM (87%; 95% CI 80.9-92.7%) and IUPC (94.8%; 95% CI 83.4-96.3%), with a significantly lower rate for TOCO (67.5%; 95% CI 59.4-76.8%, p TOCO versus IUPC (-3.34 ± 4.97). There is a high variability between the timing of TOCO contractions as compared to IUPC (4.74 ± 10.03 seconds), while a gap of 8.46 ± 4.24 seconds was detected for EUM. The sensitivity, positive predictive value and false positive rate for individual contraction identification by TOCO and EUM are 54.0%, 84.4%, 15.6% and 94.2%, 87.6%, 12.4%, respectively. EUM is efficient as IUPC for uterine activity assessment and both techniques are superior in comparison to external tocodynamometry. Our results support the use of non-invasive EMG technology to monitor uterine activity.

  18. To Compare the Diagnostic Effectiveness of Transvaginal Ultrasonography, Sonohisterography and Endometrial Biopsy in Woman with Abnormal Uterine Bleeding

    Directory of Open Access Journals (Sweden)

    Ahmet Kökden

    2005-12-01

    Full Text Available OBJECTIVE: To compare the effectiveness of saline sonohysterography in abnormal uterine bleeding with endometrial biopsy and transvaginal ultrasound. Design: Controlled clinical study. Settings: Bakirkoy Dr.Sadi Konuk Research and Training Hospital Patients: Total 51 pre and postmenopausal women age between 35 and 73 Interventions: Sonohysterography, endometrial biopsy, transvaginal ultrasound RESULTS: When we compared SIS with endometrail biopsy at the diagnosis of intracavitery lesions like myomas and polyps, endometrial biopsy diagnosed 7 on the other hand SIS diagnosed 12 of pathologies (p

  19. A comparative study of ethamsylate and mefenamic acid in dysfunctional uterine bleeding.

    Science.gov (United States)

    Chamberlain, G; Freeman, R; Price, F; Kennedy, A; Green, D; Eve, L

    1991-07-01

    The effects of ethamsylate and mefenamic acid on menstrual blood loss were compared in a double-blind trial in 34 women with menorrhagia. Both drugs produced statistically significant reductions in blood loss during the 3 months of treatment; the overall reduction was 20% in the ethamsylate group and 24% in the mefenamic acid group. Compared with pretreatment values, blood loss was significantly less in each of the 3 treatment months in the mefenamic acid group, but only in the second and third months of treatment in the ethamsylate group. However, more women had a clinically useful reduction in blood loss (greater than 40%) in the ethamsylate group. The onset of effect of mefenamic acid was rapid but ethamsylate showed a comparatively greater effect as the trial progressed. Cessation of treatment was followed by an increase in blood loss, more pronounced in mefenamic acid group who reverted to pre-treatment levels. A greater number of side-effects were reported with mefenamic acid.

  20. Uterine Cancer

    Science.gov (United States)

    ... is pregnant. There are different types of uterine cancer. The most common type starts in the endometrium, ... the uterus. This type is also called endometrial cancer. The symptoms of uterine cancer include Abnormal vaginal ...

  1. Uterine fibroids

    Science.gov (United States)

    ... Instructions Hysterectomy - abdominal - discharge Hysterectomy - laparoscopic - discharge Hysterectomy - vaginal - discharge Uterine artery embolization - discharge Images Pelvic laparoscopy Female ...

  2. Effect of vaginal progesterone suppository (200 mg on preventing preterm labor after the inhibition of uterine contractions: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Azin Alavi

    2016-10-01

    Full Text Available Preterm labor implies a childbirth before the completion of 37 weeks, and accounts for the majority of infant mortalities. Finding proper medications is essential in the treatment procedure. The present research aimed to investigate the effect of vaginal progesterone suppository (200 mg on the prevention of preterm labor after inhibiting uterine contractions. Participants were patients hospitalized in Shariati Hospital of Bandar Abbas in 2014-15. As a randomized clinical trial, the present research focused on all pregnant women who referred to Shariati Hospital in Bandar Abbas due to preterm uterine contractions in 2014-15. The inclusion criteria were: pregnancy with a singleton and passing one’s 26th-34th week of pregnancy. Through convenient sampling method, 200 women were selected to enter the study. According to the table obtained from Random Allocation software, they were randomly divided into two groups, each comprised of 100 subjects. They were monitored for 48 hours in terms of uterine contractions and then if there were no contractions and change of dilatation or cervical effacement, they were discharged. They were asked to return for a revisit one week later in their 34th week of pregnancy. SPSS (version 17 was used to analyze the data through Man-Whitney U-test, Fisher’s exact test, t-test and chi-squared test. P-value of significance was set at ≤.05. A statistically significant difference was found between the two groups in terms of the frequency of term and preterm labors (P<0.05. The Apgar score of infants in the intervention group was higher than the control (P<0.05. The rate of respiratory problems in the intervention group was significantly lower than the control (P<0.001. The rate of septicemia in the infants of the intervention group was 8% as compared to the control group 20%. The weight of infants in the intervention group was significantly higher than the control (P<0.05. Prescribing vaginal progesterone suppository

  3. Uterine artery embolization to treat uterine fibroids

    International Nuclear Information System (INIS)

    Machan, L.; Martin, M.

    2001-01-01

    The first reported application of uterine artery embolization, in 1979, was to treat life-threatening hemorrhage after a failed hysterectomy. Since then, uterine artery embolization has been used very successfully to control acute or delayed post-partum hemorrhage, post-surgical hemorrhage and hemorrhage from ectopic pregnancy, to treat uterine arteriovenous malformations and as prophylaxis before high-risk surgery, such as cesarean delivery in women with placenta previa. In contrast to these proven but underutilized applications, uterine embolization for fibroids has, in a short time, achieved significant notice in the lay press and is being widely offered. Ravina and colleagues, first reported uterine fibroid shrinkage after embolization for the treatment of acute bleeding. Since then, his group has performed over 100 procedures with up to a 6-year follow-up. The cumulative clinical success rate for the treatment of abnormal uterine bleeding due to fibroids is reported to be approximately 85% and for treatment of pain or pressure symptoms, about 75%. Six-month follow-up sonography reveals an average reduction of fibroid size of approximately 40%. However, to date, no studies have compared patients who undergo embolization with a nontreatment cohort or with surgical intervention. (author)

  4. Uterine artery embolization to treat uterine fibroids

    Energy Technology Data Exchange (ETDEWEB)

    Machan, L.; Martin, M. [Univ. of British Columbia Hospital, Dept. of Radiology, Vancouver, BC (Canada)

    2001-06-01

    The first reported application of uterine artery embolization, in 1979, was to treat life-threatening hemorrhage after a failed hysterectomy. Since then, uterine artery embolization has been used very successfully to control acute or delayed post-partum hemorrhage, post-surgical hemorrhage and hemorrhage from ectopic pregnancy, to treat uterine arteriovenous malformations and as prophylaxis before high-risk surgery, such as cesarean delivery in women with placenta previa. In contrast to these proven but underutilized applications, uterine embolization for fibroids has, in a short time, achieved significant notice in the lay press and is being widely offered. Ravina and colleagues, first reported uterine fibroid shrinkage after embolization for the treatment of acute bleeding. Since then, his group has performed over 100 procedures with up to a 6-year follow-up. The cumulative clinical success rate for the treatment of abnormal uterine bleeding due to fibroids is reported to be approximately 85% and for treatment of pain or pressure symptoms, about 75%. Six-month follow-up sonography reveals an average reduction of fibroid size of approximately 40%. However, to date, no studies have compared patients who undergo embolization with a nontreatment cohort or with surgical intervention. (author)

  5. Abnormal uterine bleeding in VTE patients treated with rivaroxaban compared to vitamin K antagonists.

    Science.gov (United States)

    De Crem, Nico; Peerlinck, Kathelijne; Vanassche, Thomas; Vanheule, Kristine; Debaveye, Barbara; Middeldorp, Saskia; Verhamme, Peter; Peetermans, Marijke

    2015-10-01

    Rivaroxaban is a convenient oral anticoagulant for patients with venous thromboembolism (VTE). The impact of rivaroxaban and vitamin K antagonists (VKAs) on abnormal uterine bleeding (AUB) in real life has not been previously explored. We performed a single-center retrospective study on AUB in female VTE patients of reproductive age who were treated with either rivaroxaban or VKAs. Questionnaire results were available for 52 patients in each treatment group. Approximately two thirds of all women reported AUB after initiation of anticoagulant therapy. Patients using rivaroxaban were more likely to experience prolonged (>8days) menstrual bleeding (27 % vs. 8.3%, P=0.017). Rivaroxaban treatment increased the duration of menstrual bleeding from median 5 (IQR 3.5-6.0) days before start of treatment to 6 (IQR 4.1-8.9) days (Pbleeding and more medical interventions and adaptation of anticoagulant treatment for AUB. These data can guide proactive discussion with patients starting anticoagulant therapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Uterine sarcoma - current perspectives.

    Science.gov (United States)

    Benson, Charlotte; Miah, Aisha B

    2017-01-01

    Uterine sarcomas comprise a group of rare tumors with differing tumor biology, natural history and response to treatment. Diagnosis is often made following surgery for presumed benign disease. Currently, preoperative imaging does not reliably distinguish between benign leiomyomas and other malignant pathology. Uterine leiomyosarcoma is the most common sarcoma, but other subtypes include endometrial stromal sarcoma (low grade and high grade), undifferentiated uterine sarcoma and adenosarcoma. Clinical trials have shown no definite survival benefit of adjuvant radiotherapy or chemotherapy and have been hampered by the rarity and heterogeneity of these disease types. There is a role of adjuvant treatment in carefully selected cases following multidisciplinary discussion at sarcoma reference centers. In patients with metastatic disease, systemic chemotherapy can then be considered. There is activity of a number of agents, including doxorubicin, trabectedin, gemcitabine-based chemotherapy, eribulin and pazopanib. Patients should be considered for clinical trial entry where possible. Close international collaboration is important to allow progress in this group of diseases.

  7. A randomised controlled trial of intra-uterine insemination versus in vitro fertilisation in patients with idiopathic or mild male infertility.

    Science.gov (United States)

    Elzeiny, Hossam; Garrett, Claire; Toledo, Manuela; Stern, Kate; McBain, John; Baker, Hugh William Gordon

    2014-04-01

    The cause of infertility is unexplained or poorly explained in 30-40% of couples undergoing standard investigations, and treatment ranges from expectant management to IUI and IVF. The aim of this study was to compare the clinical pregnancy rates and costs of intra-uterine insemination (IUI) and in vitro fertilisation (IVF) in women where the same ovarian stimulation led to the development of two or three mature follicles. A randomised controlled clinical trial compared the efficacy of IUI and IVF in a tertiary fertility centre (ISRCTN28780587). Primary outcome measures were fetal heart positive pregnancy rate and cost per live birth. The selection criteria were age: females 18-42 years and males 18-60 years, infertility for one year or more, no IVF or IUI for 12 months prior to the trial, and no coital, tubal or ovulatory disorders, oligospermia, untreated endometriosis or contraindication for multiple pregnancy. All women (n = 102) had the same dose FSH stimulation protocol. Those who developed two or three preovulatory follicles were randomised 3:1 to IUI (n = 33) or IVF (n = 10). IUI or IVF was performed 36 h after hCG administration with single or double embryo transfer on day two. Clinical pregnancy rates (40% vs 12%, P = 0.04) and live birth rate (40% vs 6%, P = 0.01) were higher for IVF than IUI. The cost per live birth was AU$8735 for IVF compared with $42,487 for IUI. This study provides evidence that IVF is more successful and cost-effective than IUI using the same doses of FSH. Further confirmatory studies are required. © 2014 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  8. The effect of uterine fundal pressure on the duration of the second stage of labor: a randomized controlled trial.

    Science.gov (United States)

    Api, Olus; Balcin, Muge Emeksiz; Ugurel, Vedat; Api, Murat; Turan, Cem; Unal, Orhan

    2009-01-01

    To determine the effect of uterine fundal pressure on shortening the second stage of labor and on the fetal outcome. Randomized controlled trial. Teaching and research hospital. One hundred ninety-seven women between 37 and 42 gestational weeks with singleton cephalic presentation admitted to the delivery unit. Random allocation into groups with or without manual fundal pressure during the second stage of labor. The primary outcome measure was the duration of the second stage of labor. Secondary outcome measures were umbilical artery pH, HCO3-, base excess, pO2, pCO2 values and the rate of instrumental delivery, severe maternal morbidity/mortality, neonatal trauma, admission to neonatal intensive care unit, and neonatal death. There were no significant differences in the mean duration of the second stage of labor and secondary outcome measures except for mean pO2 which was lower and mean pCO2 which was higher in the fundal pressure group. Nevertheless, the values still remained within normal ranges and there were no neonates with an Apgar score <7 in either of the groups. Application of fundal pressure on a delivering woman was ineffective in shortening the second stage of labor.

  9. Storage container of radium source newly manufactured for trial for intracavitary irradiation of cancer of the uterine cervix, 2

    International Nuclear Information System (INIS)

    Yamamoto, Chiaki; Sasaki, Tsuneo; Tanaka, Yoshiaki

    1977-01-01

    To decrease exposure dose from radium source to operators during the treatment of cancer of the uterine cervix, new-type storage container was manufactured and its usefullness was discussed. The new-type container manufactured for trial houses radium source, for intracavitary irradiation of cancer of the cervix, connecting with TAO-type applicator for afterloading. TLD 1200 Type was used for measurement of radiation dose, and radium 50 mCi was used per one case. The obtained results were as follows: Using the new-type container, 45-60% decrease of exposure dose in the hands and fingers and 44% decrease in the body were obtained. The exposure dose of persons engaged in work of radiotherapy for one week was only 2.2% of the maximum permissible exposure dose, The time treating radium source was shortened to 50% by using the new-type container, and the shortening of that time was a great factor of countermeasures for decreasing exposure dose to operators. From above-mentioned results, the new-type storage container can be put sufficiently to practical use as a storage container of radium source for intracavitary irradiation of cancer of the cervix (when using TAO type afterloading method). (Tsunoda, M.)

  10. Comparative evaluation of two methods care of the perioperative period after laparoscopic operations on uterine appendages

    Directory of Open Access Journals (Sweden)

    О. S. Lashkul

    2017-10-01

    Full Text Available Aim – тo assess the impact of the early multimodal rehabilitation concept on postoperative period after laparoscopic operations on uterine appendages. Маterials and methods. The study involved 79 patients who were randomized by envelope method in two groups. In the main group (26 patients, a protocol of early multimodal rehabilitation (ERAS was used. In the control group (53 patients, the traditional perioperative regimen was used. In both groups, laparoscopic operations were performed under general anesthesia with mechanical ventilation (propofol + fentanyl. In perioperative anesthesia NSAIDs (dexketoprofen, ketorolac, paracetamol were included. Non-invasive monitoring was performed by the «Leon» monitor (StO2, blood pressure, heart rate, capnogram, hourly diuresis was taken into account, thermometry was performed. In the postoperative period analgesia with combination with systemic administration of dexketoprofen (100–150 mg/day + ketorolac (60 mg/day + paracetamol (3000 mg/day was used. Results. The groups were homogeneous according to anamnestic (the beginning of menstruation, the number of pregnancies, childbirth, abortions, miscarriages, anthropometric and demographic characteristics, the duration of operations, blood loss and baseline values of systolic, diastolic, mean arterial pressures and heart rate. In groups the volumes of diuresis did not differ significantly (p < 0.05. Positive intraoperative hemohydrate balance in the FTS group was almost half that in the control group. When assessing pain at rest by VAS, a statistically significant difference was found at the 6 and 24 hours study stages. Nevertheless, at the study stages the pain level in the control group did not exceed 30 mm, which indicates adequate analgesia at rest. The level of cough pain in the control group exceeded the level of pain in the main group, the statistical difference was determined after 6 hours and 24 hours, but was above 30 mm, which required

  11. Uterine massage for preventing postpartum haemorrhage.

    Science.gov (United States)

    Hofmeyr, G Justus; Abdel-Aleem, Hany; Abdel-Aleem, Mahmoud A

    2013-07-01

    Postpartum haemorrhage (PPH) (bleeding from the genital tract after childbirth) is a major cause of maternal mortality and disability, particularly in under-resourced areas. In these settings, uterotonics are often not accessible. There is a need for simple, inexpensive techniques which can be applied in low-resourced settings to prevent and treat PPH. Uterine massage is recommended as part of the routine active management of the third stage of labour. However, it is not known whether it is effective. If shown to be effective, uterine massage would represent a simple intervention with the potential to have a major effect on PPH and maternal mortality in under-resourced settings. To determine the effectiveness of uterine massage after birth and before or after delivery of the placenta, or both, to reduce postpartum blood loss and associated morbidity and mortality. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2013). All published, unpublished and ongoing randomised controlled trials comparing uterine massage alone or in addition to uterotonics before or after delivery of the placenta, or both, with non-massage. Two researchers independently considered trials for eligibility, assessed risk of bias and extracted the data using the agreed form. Data were checked for accuracy. The effect of uterine massage commenced before or after placental delivery were first assessed separately, and then the combined for an overall result. This review included two randomised controlled trials. The first trial included 200 women who were randomised to receive uterine massage or no massage following delivery of the placenta, after active management of the third stage of labour including use of oxytocin. The numbers of women with blood loss more than 500 mL was small, with no statistically significant difference (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.16 to 1.67). There were no cases of retained placenta in either group. The mean

  12. A COMPARATIVE STUDY OF CLINICAL EXAMINATION, ULTRASOUND FINDINGS, DIAGNOSTIC HYSTEROSCOPY WITH HISTOPATHOLOGICAL EXAMINATION REPORT OF ENDOMETRIUM IN PATIENTS WITH ABNORMAL UTERINE BLEEDING

    Directory of Open Access Journals (Sweden)

    Sathenahalli Devegowda Prathibha

    2016-08-01

    Full Text Available BACKGROUND AND OBJECTIVES Abnormal Uterine Bleeding (AUB is a very frequent gynaecological complaint and occurs across the entire age spectrum, approximately 75000 hysterectomies are carried out each year with 30% of these for menstrual problems alone. These menstrual aberrations occur more commonly at extremes of reproductive life. The introduction of hysteroscopy has opened a new dimension in evaluation of patient with AUB replacing the blind technique of Dilatation and Curettage. The present study was undertaken to know the accuracy of various tests with Histopathology. MATERIALS AND METHODS The present prospective study was carried out on 100 patients from reproductive, perimenopausal and postmenopausal age group with abnormal uterine bleeding in Dr. B. R. Ambedkar Medical College and Hospital. RESULTS In the present study, in relation to histopathological examination, clinical findings and hysteroscopy had better accuracy (72% as compared to ultrasound findings (41% in diagnosis of abnormal uterine bleeding. CONCLUSION Hysteroscopy guided biopsy and histopathology complements each other in the evaluation of patient with abnormal uterine bleeding for accurate diagnosis and further treatment.

  13. Uterine arterial embolization to treat uterine leiomyoma

    International Nuclear Information System (INIS)

    Wang Huali; Han Lu; Wang Feng

    2002-01-01

    Objective: To assess the clinical effects of uterine arterial embolization on uterine leiomyoma. Methods: The authors treated 21 patients with uterine leiomyoma by Seldinger's uterine arterial embolization. The 4.0 F Cobra catheter was laced into the double uterine arteries with Polyvinyl Alcohol Foam (PVA) particles as the embolization. At 3 and 6 months postoperatively, the authors investigated the effects of the embolization. Results: After uterine arterial embolization, the volume of uterine leiomyoma decreased and menorrhagia was under controlled. The symptoms of anemia and oppression were relieved. The physiologic functions of ovary and uterus were preserved completely. Conclusions: Uterine arterial embolization is an effective and less invasive way to treat uterine leiomyoma

  14. Comparing the effects of low-dose contraceptive pills to control dysfunctional uterine bleeding by oral and vaginal methods.

    Science.gov (United States)

    Mehrabian, Ferdous; Abbassi, Fariba

    2013-09-01

    Background and Objective : Contraceptive pills are generally taken orally and can cause side effects such as nausea, vomiting and hypertension. The vaginal use of these pills can reduce such complications. Our objective was to compare the efficacy and side effects of low dose contraceptive pills by oral and vaginal route in the management of dysfunctional uterine bleeding-(DUB) Methods: This comparative observational study was conducted at Beheshti and Alzahra (SA) teaching hospitals, affiliated to Isfahan University of Medical Sciences in 2010-2011. One hundred women who presented with DUB were randomly assigned into two groups of equal number, receiving the low dose oral contraceptive pills by oral or vaginal route for three month. The amount and duration of bleeding were compared at the beginning and at the end of the study and side effects by these two methods compared. The results of this study showed that both oral and vaginal routes effectively reduced the duration and amount of bleeding due to DUB after three courses of treatment. This effect was better in the vaginal method compared with oral administration (P = 0.03). Regarding the side effects, nausea and vomiting were significantly higher in the oral group than in the vaginal group (P = 0.03). Vulvovaginitis infection was more frequent in the vaginal group than in the oral group (P = 0.03). Low dose contraceptive pills are effective in reducing the amount, time, and duration of bleeding in patients with DUB. In addition, reduction of gastrointestinal side effects by vaginal route helps to use these pills by the patient with proper training of physicians, midwives and patients.

  15. Uterine sacculation.

    Science.gov (United States)

    Spearing, G J

    1978-01-01

    A case of uterine sacculation is reported in which a classic cesarean section was required for safe delivery. The definition and diagnosis of the condition and some difficulties in management are discussed.

  16. Uterine sarcoma

    Science.gov (United States)

    ... Livingstone; 2014:chap 88. Crum CP, Laury AR, Hirsch MS, Quick CM, Peters WA. Undifferentiated uterine sarcoma. ... Crum CP, Quick CM, Laury AR, Peters WA, Hirsch MS, eds. Gynecologic and Obstetric Pathology . Philadelphia, PA: ...

  17. Comparison of the Efficacy of the Embolic Agents Acrylamido Polyvinyl Alcohol Microspheres and Tris-Acryl Gelatin Microspheres for Uterine Artery Embolization for Leiomyomas: A Prospective Randomized Controlled Trial

    International Nuclear Information System (INIS)

    Worthington-Kirsch, Robert L.; Siskin, Gary P.; Hegener, Paul; Chesnick, Richard

    2011-01-01

    Objective: To evaluate the efficacy of acrylamido polyvinyl alcohol microspheres (a-PVAM) as an embolic agent for uterine artery embolization (UAE) compared with Tris-acryl gelatin microspheres (TAGM).Design, Setting, ParticipantsProspective randomized double-blind noninferiority trial. Conducted at two sites both with regional UAE practices. Forty-six women with symptomatic leiomyomas.InterventionUAE procedure was performed with either of the two embolic agents. Either 700–900-μm a-PVAM or 500–700-μm TAGM was used.Main Outcome MeasuresChanges in leiomyoma perfusion, overall uterine volume, and dominant leiomyomas volume measured by contrast-enhanced magnetic resonance imaging at 1 week, 3 months, and 6 months after UAE by a reader blinded to the embolic agent used. Changes in Uterine Fibroid Symptoms and Quality of Life questionnaire scores were measured at 3, 6, and 12 months after UAE. Results: Forty-six patients were randomized and treated under the study protocol (a-PVAM n = 22, TAGM n = 24). There were no procedure-related complications. Two patients were excluded from analysis (one technical failure of the procedure, one withdrawal from study). Successful (>90%) leiomyoma devascularization was observed in 81% of subjects at 1 week after UAE, 97% at 3 months after UAE, and 95% at 6 months after UAE. No significant differences were observed in 14 of 15 outcome measurements, consistent with noninferiority. TAGM was slightly superior to a-PVAM on one comparison (overall quality of life at 3 months after UAE).

  18. Do knowledge of uterine artery resistance in the second trimester and targeted surveillance improve maternal and perinatal outcome? UTOPIA study: a randomized controlled trial.

    Science.gov (United States)

    García, B; Llurba, E; Valle, L; Gómez-Roig, M D; Juan, M; Pérez-Matos, C; Fernández, M; García-Hernández, J A; Alijotas-Reig, J; Higueras, M T; Calero, I; Goya, M; Pérez-Hoyos, S; Carreras, E; Cabero, L

    2016-06-01

    To ascertain whether screening for pre-eclampsia (PE) and intrauterine growth restriction (IUGR) by uterine artery (UtA) Doppler in the second trimester of pregnancy and targeted surveillance improve maternal and perinatal outcomes in an unselected population. This was a multicenter randomized open-label controlled trial. At the routine second-trimester anomaly scan, women were assigned randomly to UtA Doppler or non-Doppler groups. Women with abnormal UtA Doppler were offered intensive surveillance at high-risk clinics of the participating centers with visits every 4 weeks that included measurement of maternal blood pressure, dipstick proteinuria, fetal growth and Doppler examination. The primary outcome was a composite score for perinatal complications, defined as the presence of any of the following: PE, IUGR, spontaneous labor 90(th) percentile was able to detect 59% of early-onset PE and 60% of early-onset IUGR with a false-positive rate of 11.1%. When perinatal and maternal data according to assigned group (UtA Doppler vs non-Doppler) were compared, no differences were found in perinatal or maternal complications. However, screened patients had more medical interventions, such as corticosteroid administration (relative risk (RR), 1.79 (95% CI, 1.4-2.3)) and induction of labor for IUGR (RR, 1.36 (95% CI, 1.07-1.72)). In women developing PE or IUGR, there was a trend towards fewer maternal complications (RR, 0.46 (95% CI, 0.19-1.11)). Routine second-trimester UtA Doppler ultrasound in an unselected population identifies approximately 60% of women at risk for placental complications; however, application of this screening test failed to improve short-term maternal and neonatal morbidity and mortality. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

  19. Uterine fibroid management: from the present to the future

    Science.gov (United States)

    Donnez, Jacques; Dolmans, Marie-Madeleine

    2016-01-01

    Abstract Uterine fibroids (also known as leiomyomas or myomas) are the most common form of benign uterine tumors. Clinical presentations include abnormal bleeding, pelvic masses, pelvic pain, infertility, bulk symptoms and obstetric complications. Almost a third of women with leiomyomas will request treatment due to symptoms. Current management strategies mainly involve surgical interventions, but the choice of treatment is guided by patient's age and desire to preserve fertility or avoid ‘radical’ surgery such as hysterectomy. The management of uterine fibroids also depends on the number, size and location of the fibroids. Other surgical and non-surgical approaches include myomectomy by hysteroscopy, myomectomy by laparotomy or laparoscopy, uterine artery embolization and interventions performed under radiologic or ultrasound guidance to induce thermal ablation of the uterine fibroids. There are only a few randomized trials comparing various therapies for fibroids. Further investigations are required as there is a lack of concrete evidence of effectiveness and areas of uncertainty surrounding correct management according to symptoms. The economic impact of uterine fibroid management is significant and it is imperative that new treatments be developed to provide alternatives to surgical intervention. There is growing evidence of the crucial role of progesterone pathways in the pathophysiology of uterine fibroids due to the use of selective progesterone receptor modulators (SPRMs) such as ulipristal acetate (UPA). The efficacy of long-term intermittent use of UPA was recently demonstrated by randomized controlled studies. The need for alternatives to surgical intervention is very real, especially for women seeking to preserve their fertility. These options now exist, with SPRMs which are proven to treat fibroid symptoms effectively. Gynecologists now have new tools in their armamentarium, opening up novel strategies for the management of uterine fibroids. PMID

  20. Midpregnancy Doppler ultrasound of the uterine artery in metformin- versus placebo-treated PCOS women: a randomized trial.

    Science.gov (United States)

    Stridsklev, Solhild; Carlsen, Sven M; Salvesen, Øyvind; Clemens, Ilka; Vanky, Eszter

    2014-03-01

    Metformin is used to reduce pregnancy complications in women with polycystic ovary syndrome (PCOS), although it is not approved for this indication and solid evidence is lacking. Midpregnancy Doppler ultrasound is one of the best methods for prediction of adverse pregnancy outcome. The objectives of the study were to investigate the following: 1) whether metformin treatment influenced the midpregnancy pulsatility index (PI) of the uterine artery; 2) whether metabolic or endocrine factors affect the PI of the uterine artery of PCOS women; and 3) whether PI predicted adverse pregnancy outcome in PCOS woman. This is a substudy of a randomized, placebo-controlled, double-blind, multicenter study conducted at 11 secondary care centers. We randomly assigned 273 pregnancies to receive metformin or placebo, from the first trimester of pregnancy to delivery. In the present substudy, 231 pregnancies are included, ie, those who completed the ultrasound examinations. Midpregnancy PI in the uterine artery related to metformin use, androgen levels, an oral glucose tolerance test, and insulin levels was measured. We found no difference in the PI between the metformin and placebo groups. In multivariate analyses, fasting serum glucose of the first and second trimester correlated positively to the midpregnancy PI. Only in univariate analyses a weak correlation between androstenedione and PI was seen. Metformin treatment did not affect uterine artery blood flow, measured by PI. High fasting blood glucose correlated inversely to uterine artery blood flow. The midpregnancy PI correlated positively to preeclampsia, hypertension, and gestational diabetes mellitus in PCOS pregnancies. Androgen levels correlated only to PI in univariate analyses.

  1. The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial

    NARCIS (Netherlands)

    Vervoort, A. J. M. W.; van der Voet, L. F.; Witmer, M.; Thurkow, A. L.; Radder, C. M.; van Kesteren, P. J. M.; Quartero, H. W. P.; Kuchenbecker, W. K. H.; Bongers, M. Y.; Geomini, P. M. A. J.; de Vleeschouwer, L. H. M.; van Hooff, M. H. A.; van Vliet, H. A. A. M.; Veersema, S.; Renes, W. B.; van Meurs, H. S.; Bosmans, J.; Oude Rengerink, K.; Brölmann, H. A. M.; Mol, B. W. J.; Huirne, J. A. F.

    2015-01-01

    A caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce

  2. Abnormal uterine bleeding

    Science.gov (United States)

    Anovulatory bleeding; Abnormal uterine bleeding - hormonal; Polymenorrhea - dysfunctional uterine bleeding ... ACOG committee opinion no. 557: Management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women. Reaffirmed 2015. www. ...

  3. Prednisolone Trial: Study protocol for a randomised controlled trial of prednisolone for women with idiopathic recurrent miscarriage and raised levels of uterine natural killer (uNK cells in the endometrium

    Directory of Open Access Journals (Sweden)

    Drury Jo

    2009-11-01

    Full Text Available Abstract Background Idiopathic recurrent miscarriage is defined as 3 consecutive pregnancy losses with no contributing features found on investigations. At present there are no treatments of proven efficacy for idiopathic recurrent miscarriage. Uterine natural killer (uNK cells, the most predominant leucocyte in the endometrium are adjacent to foetal trophoblast cells and thought to be involved in implantation. The exact mechanisms of how uNK cells affect implantation are not clear but are probably through the regulation of angiogenesis. Multiple studies have shown an association between high density of uterine natural killer cells and recurrent miscarriage. We have shown that prednisolone reduces the number of uNK cells in the endometrium. The question remains as to whether reducing the number of uNK cells improves pregnancy outcome. Methods We propose a randomised, double-blind, placebo controlled trial of prednisolone with a pilot phase to assess feasibility of recruitment, integrity of trial procedures, and to generate data to base future power calculations. The primary aim is to investigate whether prednisolone therapy during the first trimester of pregnancy is able to improve live birth rates in patients with idiopathic recurrent miscarriage and raised uNK cells in the endometrium. Secondary outcomes include conception rate, karyotype of miscarriage, miscarriages (first and second trimester, stillbirths, pregnancy complications, gestational age at delivery, congenital abnormality and side effects of steroids. The trial has 2 stages: i screening of non-pregnant women and ii randomisation of the pregnant cohort. All patients who fit the inclusion criteria ( Trial Registration Current Controlled Trials ISRCTN28090716

  4. Uterine fibroid embolization

    International Nuclear Information System (INIS)

    Totev, M.

    2013-01-01

    Full text: Introduction: Today, after numerous lengthy randomized trials embolization of uterine fibroids has become a standard treatment. Percutaneous embolization of myomas is a micro - invasive surgery, which can be regarded as an alternative to traditional surgery. Although these data 2/3 of the patients were not informed about this treatment option. What you will learn: The uterine embolization is minimal invasive non-surgical procedure. It is an alternative treatment to surgery. Under local anesthesia in the femoral artery puncture reaches the internal iliac artery and uterine arteries. Reached selectively by the catheter and chemicals, which causes clogging, are injected into them. In the vessels that feed fibroids occur a process like an attack, the feeding stops, it starts to shrink and it is replaced by fibrous tissue. The blood vessels of the healthy tissue are different in size and have a plurality of collateral connections as opposed to those of the myoma and thus the blood supply to the normal tissue of the uterus is not distorted. Discussion: Nowadays there are more well- calibrated materials for embolization and those with a particle size of about 700µ are proven as the most successful. The procedure is well tolerated, but after a pain occurs, which has to be covered with anesthetics. Usually pain and metrorrhagia disappear immediately. The fibroids themselves shrink to varying degrees. Hospital stay was significantly shorter than that after surgery, and remained fertile power. Complications are few and rare require further treatment. Multiple nodes are problematic and it is difficult to detect the primary one. A three and six months tracking by MRI is desirable. Conclusion: Embolization of uterine myoma is an established method of treatment primarily on clinical symptoms resulting therefrom. In all patients rapidly disappear metrorrhagia symptoms and morbidity, the volume of the assembly decrease, which together with shorter hospital stays and

  5. Uterine activity monitoring during labour--a multi-centre, blinded two-way trial of external tocodynamometry against electrohysterography.

    Science.gov (United States)

    Reinhard, J; Hayes-Gill, B R; Schiermeier, S; Löser, H; Niedballa, L M; Haarmann, E; Sonnwald, A; Hatzmann, W; Heinrich, T M; Louwen, F

    2011-10-01

    The aim of this study was to determine the quality of intrapartum uterine activity (UA) monitoring in daily practice during the first and second stages of labour. The total duration of inadequate UA monitoring is quantified in relation to the technique applied, namely, external tocodynamometry (TOCO) or electrohysterography (EHG). 144 UA recordings, collected from 1st September 2008 until 15th October 2009 from deliveries at the Marien-Hospital Witten, Germany, were analysed by obstetricians based at different centres. The included recordings were from singleton and simultaneously with external TOCO and EHG monitored pregnancies. External TOCO and EHG UA recordings were blinded. The percentages of "adequate" UA recordings in the first and second stages of labour were much higher for the external EHG than the external TOCO mode (pTOCO. Intrapartum UA monitoring in -daily practice via the EHG mode provides a more recognisable UA trace than the TOCO. © Georg Thieme Verlag KG Stuttgart · New York.

  6. Can Intrapartum Cardiotocography Predict Uterine Rupture among Women with Prior Caesarean Delivery?: A Population Based Case-Control Study.

    Directory of Open Access Journals (Sweden)

    Malene M Andersen

    Full Text Available To compare cardiotocographic abnormalities recorded during labour in women with prior caesarean delivery (CD and complete uterine rupture with those recorded in controls with prior CD without uterine rupture.Women with complete uterine rupture during labour between 1997 and 2008 were identified in the Danish Medical Birth Registry (n = 181. Cases were validated by review of medical records and 53 cases with prior CD, trial of labour, available cardiotocogram (CTG and complete uterine rupture were included and compared with 43 controls with prior CD, trial of labour and available CTG. The CTG tracings were assessed by 19 independent experts divided into groups of three different experts for each tracing. The assessors were blinded to group, outcome and clinical data. They analyzed occurrence of defined abnormalities and classified the traces as normal, suspicious, pathological or pre-terminal according to international guidelines (FIGO.A pathological CTG during the first stage of labour was present in 77% of cases and in 53% of the controls (OR 2.58 [CI: 0.96-6.94] P = 0.066. Fetal tachycardia was more frequent in cases with uterine rupture (OR 2.50 [CI: 1.0-6.26] P = 0.053. Significantly more cases showed more than 10 severe variable decelerations compared with controls (OR 22 [CI: 1.54-314.2] P = 0.022. Uterine tachysystole was not correlated with the presence of uterine rupture.A pathological cardiotocogram should lead to particular attention on threatening uterine rupture but cannot be considered a strong predictor as it is common in all women with trial of labour after caesarean delivery.

  7. Medical Treatment of Uterine Leiomyoma

    Science.gov (United States)

    Sabry, Mohamed; Al-Hendy, Ayman

    2012-01-01

    Uterine leiomyomas (also called myomata or fibroids) are the most common gynecologic tumors in the United States. The prevalence of leiomyomas is at least 3 to 4 times higher among African American women than in white women. Pathologically, uterine leiomyomas are benign tumors that arise in any part of the uterus under the influence of local growth factors and sex hormones, such as estrogen and progesterone. These common tumors cause significant morbidity for women and they are considered to be the most common indication for hysterectomy in the world; they are also associated with a substantial economic impact on health care systems that amounts to approximately $2.2 billion/year in the United States alone. Uterine myomas cause several reproductive problems such as heavy or abnormal uterine bleeding, pelvic pressure, infertility, and several obstetrical complications including miscarriage and preterm labor. Surgery has traditionally been the gold standard for the treatment of uterine leiomyomas and has typically consisted of either hysterectomy or myomectomy. In recent years, a few clinical trials have evaluated the efficacy of orally administered medications for the management of leiomyoma-related symptoms. In the present review, we will discuss these promising medical treatments in further detail. PMID:22378865

  8. Comparative trials in registration files of cardiovascular drugs : Comparator drugs and dosing schemes.

    NARCIS (Netherlands)

    Wieringa, NF; Vos, R; de Graeff, PA

    Registration files of 13 cardiovascular drugs were analysed with respect to the number of double-blind phase-III clinical trials, the use of placebo and active comparator drugs and their dosing schemes. Half of the 146 double-blind trials used active comparator drugs. The majority of files included

  9. Carcinoma of the uterine cervix

    International Nuclear Information System (INIS)

    Hayakawa, Norihiko

    1992-01-01

    There are few reports on uterine cancer in relation to radiation. This chapter discusses uterine cancer in A-bomb survivors, with special reference to the mortality rate, in a review of the literature. The Atomic Bomb Casualty Commission has first discovered 28 cases of uterine cancer among A-bomb survivors during the period 1953-1957. Since 1970, mortality rate from uterine cancer has been investigated statistically according to the T65D system. The Radiation Effect Research Foundation (RERF) has revealed 282 death cases from uterine cancer during the period 1950-1974. The RERF's data up to 1982 has revealed no radiation-dependent mortality from uterine cancer. More recent data (1950-1985) has revealed that mortality rate was increased by 22% in A-bomb survivors exposed to 1 Gy or more. When mortality of uterine cancer was investigated statistically using the 1968-1982 data for the population of the Research Institute for Nuclear Medicine and Biology, Hiroshima University, it was 1.2 times higher in the entire exposed group and 1.4 times higher in the group of proximally exposed A-bomb survivors (within 2 km from the hypocenter) than the non-exposed group, with statistically significant difference. It tended to be high in the group of distally exposed A-bomb survivors (who entered the city within 3 days after A-bombing) than the non-exposed group. When comparing the group of Hiroshima City with the group of Hiroshima Prefecture, mortality from uterine cancer was 1.3 times higher in the municipal group for proximally exposed A-bomb survivors and 1.3 times higher in the prefectural group for distally exposed A-bomb survivors and the others. Mortality rate was highest within one year after the acquisition of health handbook in the exposed group. (N.K.)

  10. The clinical efficacy of methotrexate and 5-fluorouracil in the interventional treatment of uterine incisional pregnancy after cesarean section: a comparative study

    International Nuclear Information System (INIS)

    Zhang Lei; Gu Weijin; Wan Jun; Ji Lihua; Wang Haiyun; Wang Ying; Ji Fang; Chen Qing

    2012-01-01

    Objective: To compare the interventional therapeutic efficacy of methotrexate (MTX) with that of 5-fluorouracil (5-FU) in treating uterine incisional pregnancy after cesarean section. Methods: A total of 92 patients with uterine incisional pregnancy after cesarean section, who were admitted to the hospital during the period from 2007 to 2010, were randomly divided into two groups: group MTX and group 5-FU. Patients in group MTX (n=46) received intra-arterial infusion of MTX (60-200) mg, which was followed by arterial embolization. Patients in group 5-FU (n=46) received intra-arterial infusion of 5-FU (1000-1250) mg, which was followed by arterial embolization. After the treatment the serum β-HCG and progesterone levels were determined daily for three succeeding days. The patients were followed up for three months. The clinical results were compared between the two groups. Results: The cure rates in group MTX and group 5-FU were 97.2% and 100%, respectively. No significant difference in cure rate existed between the two groups (P>0.05). A rapid fall in the serum β-HCG and progesterone levels within 1-3 days after the treatment were detected in 40 cases of group MTX and 38 cases of group 5-FU, and the decreasing extent was over 50%-80%, but the difference between the two groups was not significant (P>0.05). At the operation day, all patients of both groups had abdominal pain, and three patients in group MTX and 2 patients in 5-FU group had nausea and vomiting, but the difference between the two groups was not significant (P>0.05). During the follow-up period, no significant difference in the recovery time of the mental cycle and the hormone levels were found between the two groups (P>0.05). Conclusion: For the interventional treatment of uterine incisional pregnancy after cesarean section, the use of MTX has the same clinical efficacy as the use of 5-FU does. (authors)

  11. Uterine sarcoma – current perspectives

    Directory of Open Access Journals (Sweden)

    Benson C

    2017-08-01

    Full Text Available Charlotte Benson,1 Aisha B Miah1,2 1Sarcoma Unit, Royal Marsden Hospital, 2Department of Radiotherapy and Imaging, The Institute of Cancer Research, London, UK Abstract: Uterine sarcomas comprise a group of rare tumors with differing tumor biology, natural history and response to treatment. Diagnosis is often made following surgery for presumed benign disease. Currently, preoperative imaging does not reliably distinguish between benign leiomyomas and other malignant pathology. Uterine leiomyosarcoma is the most common sarcoma, but other subtypes include endometrial stromal sarcoma (low grade and high grade, undifferentiated uterine sarcoma and adenosarcoma. Clinical trials have shown no definite survival benefit of adjuvant radiotherapy or chemotherapy and have been hampered by the rarity and heterogeneity of these disease types. There is a role of adjuvant treatment in carefully selected cases following multidisciplinary discussion at sarcoma reference centers. In patients with metastatic disease, systemic chemotherapy can then be considered. There is activity of a number of agents, including doxorubicin, trabectedin, gemcitabine-based chemotherapy, eribulin and pazopanib. Patients should be considered for clinical trial entry where possible. Close international collaboration is important to allow progress in this group of diseases. Keywords: sarcoma, leiomyosarcoma, endometrial stromal sarcoma, undifferentiated uterine sarcoma, leiomyoma

  12. Labor Dystocia and the Risk of Uterine Rupture in Women with Prior Cesarean.

    Science.gov (United States)

    Vachon-Marceau, Chantale; Demers, Suzanne; Goyet, Martine; Gauthier, Robert; Roberge, Stéphanie; Chaillet, Nils; Laroche, Jasmin; Bujold, Emmanuel

    2016-05-01

    Objective The objective of this study was to evaluate the association between labor dystocia and uterine rupture. Methods We performed a secondary analysis of a multicenter case-control study that included women with single, prior, low-transverse cesarean section who experienced complete uterine rupture during a trial of labor (TOL). For each case, three women who underwent a TOL without uterine rupture were selected as controls. Data were collected on cervical dilatations from admission to delivery. We evaluated the relationship between uterine rupture and labor dystocia according to several criteria, including the World Health Organization's (WHO's) partogram. Results Data were available for 90 cases and 260 controls. Compared with the controls, uterine rupture was associated with less cervical dilatation on admission, slower cervical dilatation in the first stage of labor and longer second stage of labor (all with p dystocia is a significant risk factor for uterine rupture. Labor progression should be assessed regularly in women with prior cesarean. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  13. The impact of adjuvant radiation therapy on survival in women with uterine carcinosarcoma

    International Nuclear Information System (INIS)

    Clayton Smith, D.; Kenneth Macdonald, O.; Gaffney, David K.

    2008-01-01

    Background and purpose: Uterine carcinosarcoma is an aggressive neoplasm and the benefit of adjuvant radiation therapy (RT) is unclear. This retrospective study analyzes the influence of RT on survival using a large population database. Materials and methods: Data were obtained from the Surveillance, Epidemiology, and End Results (SEER) program of the US National Cancer Institute. Women with uterine carcinosarcoma who underwent primary surgery were eligible. Survival rates and multivariate analyses were performed by standard methods. Results: Of the 2461 women in the analysis, 890 received adjuvant RT. Five-year rates of overall survival were 41.5% and 33.2% (P < 0.001) and uterine-specific survival were 56.0% and 50.8% (P = 0.005), for women receiving RT compared to those who did not. Women with stages I-III disease experienced a benefit in overall survival (HR 0.87, P = 0.03) while women with stage IV disease experienced benefits in overall (HR 0.63, P < 0.001) and uterine-specific survival (HR 0.63, P = 0.004) with RT. Conclusions: RT predicted for improved overall and disease specific survival in women with uterine carcinosarcoma within the SEER database. The benefit in disease specific survival was restricted to stage IV disease. These benefits may indicate a role for adjuvant RT in future prospective trials in the treatment of uterine carcinosarcoma

  14. High-flavanol and high-theobromine versus low-flavanol and low-theobromine chocolate to improve uterine artery pulsatility index: a double blind randomized clinical trial.

    Science.gov (United States)

    Bujold, Emmanuel; Leblanc, Vicky; Lavoie-Lebel, Élise; Babar, Asma; Girard, Mario; Poungui, Lionel; Blanchet, Claudine; Marc, Isabelle; Lemieux, Simone; Belkacem, Abdous; Sidi, Elhadji Laouan; Dodin, Sylvie

    2017-09-01

    To evaluate the impact of high-flavanol and high-theobromine (HFHT) chocolate in women at risk of preeclampsia (PE). We conducted a single-center randomized controlled trial including women with singleton pregnancy between 11 and 14 weeks gestation who had bilateral abnormal uterine artery (UtA) waveforms (notching) and elevated pulsatility index (PI). Participants were randomized to either HFHT or low-flavanol and low-theobromine (LFLT) chocolate (30 grams daily for a total of 12 weeks). UtA PI, reported as multiple of medians (MoM) adjusted for gestational age, was assessed at baseline and 12 weeks after randomization. One hundred thirty-one women were randomized with mean gestational age of 12.4 ± 0.6 weeks and a mean UtA PI of 1.39 ± 0.31 MoM. UtA PI adjusted for gestational age significantly decreased from baseline to the second visit (12 weeks later) in the two groups (p chocolate, daily intake of HFHT chocolate was not associated with significant changes of UtA PI. Nevertheless, the improvement observed in both groups suggests that chocolate could improve placental function independently of flavanol and/or theobromine content.

  15. Uterine leiomyoma

    International Nuclear Information System (INIS)

    Swe, Than-Than; Onitsuka, Hideo; Kawamoto, Kenji; Ueyama, Toshihiko; Tsuruchi, Nobuhiro; Masuda, Kouji

    1992-01-01

    To correlate the signal intensity of uterine leiomyoma with its pathologic characteristics, with particular emphasis on the fibrous component, 33 magnetic resonance (MR) examinations that revealed 93 leiomyomas were prospectively studied. All patients were imaged in axial and sagittal planes with different spin-echo pulse sequences to obtain T 1 -, T 2 -weighted, and proton density images. Nondegenerative leiomyomas (N-62) showing a homogeneous signal of low intensity, and degenerative leiomyomas (N-31) with a heterogeneous signal of variable intensity on T 2 -weighted images could be correlated. Histopathological assessment of fiber constitution and degeneration, and MR intensity were interpreted by independent observers. There was excellent accord between the averages for MR intensity, T 2 relaxation time and fiber content, although the intensity values in each fiber grade showed a wide range. The greater the fiber content the lower the MR intensity on T 2 -weighted images, and the shorter the T 2 relaxation time (p<0.0001). In addition, the manner in which fiber distribution affected MR appearance was also elucidated. These data contribute to guidelines for precise tissue differentiation of myogenic tumors on MR images, and for MR imaging tissue diagnosis of any lesion with a considerable fibrous element. (author)

  16. Clinical Trial Of Glimepiride Compared With Glibenclamide For ...

    African Journals Online (AJOL)

    Objective: The study was undertaken to compare the efficacy and safety of Glimepiride against Glibenclamide in the management of patients with type 2 DM in Jos, Nigeria. Study design: An open, randomised controlled trial. Setting: Diabetes Clinic of the Jos University Teaching Hospital, Jos, Nigeria. Subjects: Seventy four ...

  17. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  18. A retrospective comparison of microwave ablation and high intensity focused ultrasound for treating symptomatic uterine fibroids

    Energy Technology Data Exchange (ETDEWEB)

    Zhao, Wen-Peng, E-mail: zwp215@163.com; Han, Zhi-Yu, E-mail: hanzhiyu301@hotmail.com; Zhang, Jing, E-mail: zjbch@sina.com; Liang, Ping, E-mail: liangping301@hotmail.com

    2015-03-15

    Highlights: •Both HIFU and PMWA are thermal ablation techniques and they all provide safe and reliable alternative treatment methods for uterine fibroids. •However, whether there are obvious difference between these two kinds of approaches in improving symptom, treatment time, ablation rate, regression rate and adverse events, until now, there are no clinical trials which have been performed to compare the therapeutic effects of HIFU and PMWA. •In this research, we retrospectively compare the results of these two treatment methods. •To our knowledge, our study is the first directly comparing long-term outcome after PMWA and HIFU in patients with uterine fibroids. -- Abstract: Objectives: To retrospectively compare the effectiveness and safety of percutaneous microwave ablation (PMWA) and ultrasound-guided high-intensity focused ultrasound (USgHIFU) for treating symptomatic uterine fibroids. Methods: Seventy-three women with symptomatic uterine fibroids who met the inclusion criteria were enrolled in our study from September 2012 to December 2013. Thirty-one patients with forty uterine fibroids underwent PMWA, and forty-two patients with fifty-one uterine fibroids underwent USgHIFU. A contrast-enhanced MRI was performed before and after treatment, and all patients were followed up for 6 months. Assessment endpoints included symptom severity scores (SSS), treatment time, ablation rate, fibroid regression rate and adverse events. Results: The mean age of the patients in our study was 35.4 ± 6.2 years (range, 21–49 years), and the median volume of uterine fibroids was 95.7 cm{sup 3} (60.3–131.5 cm{sup 3}). The ablation rate of uterine fibroids was 79.8 ± 18.2% and 77.1 ± 14.9% in the PMWA group and the USgHIFU group, respectively, and showed no significant difference between the groups. Changes in SSS after PMWA were similar in the PMWA group (47.7 pre-treatment vs. 29.9 post-treatment) and USgHIFU group (42.1 pre-treatment vs. 24.6 post-treatment). The

  19. Randomized clinical trial comparing cold knife conization of the cervix with and without lateral hemostatic sutures.

    Science.gov (United States)

    Bueno, Letícia Rossi; Binda, Marcia; Monego, Heleusa; Scherer, Roberta Luísa; Rolim, Karen Machado; Bottini, Alessandra Leal; Fregnani, José H T G; dos Reis, Ricardo

    2015-06-01

    Compare blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures in the cervical branches of the uterine arteries. Randomized clinical trial. Hospital de Clínicas de Porto Alegre (HCPA). 102 patients that underwent cold knife conization. Women that underwent cold knife conization of the cervix were randomized to undergo the procedure with or without lateral hemostatic sutures. blood loss measured in grams. operative time and postoperative intervention. Only the participants were blinded to group assignment. From March 2009 to August 2012, patients were randomly assigned to one of the study groups. There were no differences in amount of blood loss between patients that underwent the procedure with and without sutures (p = 0.39). Operative time was shorter in the group without suture (p = 0.020). There were no differences in intervention due to bleeding (p = 0.20). Blood loss was greater among menstruating women than for menopausal women (p = 0.011). There were no differences in amount of blood lost between smoking and nonsmoking patients (p = 0.082). Lateral hemostatic sutures do not affect the amount of intraoperative bleeding or the number of postoperative interventions. Their use is not necessary because they result in longer operative time, have a higher cost due to the use of suture material and pose the risk of ureter lesion in case the sutures are not placed at a lower position in the cervix. ClinicalTrials. gov identifier: NCT02184975. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  20. A randomised controlled trial comparing oxytocin and oxytocin + ...

    African Journals Online (AJOL)

    Background. Globally 166 000 women die annually as a result of obstetric haemorrhage. More than 50% of these deaths occur in sub- Saharan Africa. Uterine atony is the commonest cause of severe postpartum haemorrhage (PPH). Bleeding at or after caesarean section (CS) is responsible for >30% of maternal deaths ...

  1. Uterine artery embolisation versus hysterectomy for leiomyomas: primary and 2-year follow-up results of a randomised prospective clinical trial

    International Nuclear Information System (INIS)

    Ruuskanen, Anu; Hippelaeinen, Maritta; Sipola, Petri; Manninen, Hannu

    2010-01-01

    To compare uterine artery embolisation (UAE) and hysterectomy for the treatment of leiomyomas at 2-year follow-up in a prospective, randomised, single-centre study. Fifty-seven symptomatic patients were randomised to UAE (n = 27) or hysterectomy (n = 30). Complications, recovery, reinterventions and satisfaction with treatment were recorded. Primary endpoint was improvement of symptoms. Analyses were performed by intent-to-treat and per protocol. Two hysterectomy patients (7%) developed major complications. Hospital discharge occurred earlier after UAE than after hysterectomy (p < 0.001). Length of sick leave was longer after hysterectomy than after UAE (p < 0.001). Twenty-two (82%) UAE patients and 28 (93%) hysterectomy patients reported overall relief of symptoms (p = 0.173). In 12/18 (67%) UAE patients menorrhagia was completely resolved or reduced. Improvement of pressure symptoms was reported significantly more by UAE patients than by hysterectomy patients (19/20 [95%] versus 18/26 [69%], respectively; p = 0.029). Five (19%) UAE patients underwent additional interventions due to worsening symptoms. Twenty-four (89%) UAE patients and 29 (97%) hysterectomy patients would have chosen treatment again (p = 0.336). UAE gave relief of symptoms (apart from menorrhagia) comparable to hysterectomy with less severe complications, but with an increased rate of secondary interventions. UAE may be the preferable treatment especially for patients with pressure symptoms. (orig.)

  2. Uterine Artery Embolization versus Myomectomy: Impact on Quality of Life—Results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial

    International Nuclear Information System (INIS)

    Manyonda, Isaac T.; Bratby, Mark; Horst, Jessica S.; Banu, Nassera; Gorti, Maha; Belli, Anna-Maria

    2012-01-01

    Purpose: This study was designed to compare quality of life (QoL) outcomes after uterine artery embolization (UAE) or myomectomy. Methods: Women with symptomatic fibroids diagnosed by ultrasound who wished to preserve their uterus were randomized to myomectomy (n = 81) or UAE (n = 82). Endpoints at 1 year were QoL measured by a validated questionnaire, hospital stay, rates of complications, and need for reintervention. Results: UAE patients had shorter hospitalization (2 vs. 6 days, p < 0.001). By 1 year postintervention, significant and equal improvements in QoL scores had occurred in both groups (myomectomy n = 59; UAE n = 61). There had been two (2.9%) major complications among UAE versus 6 (8%) among myomectomy patients (not significant). By 2 years, among UAE patients (n = 57) there were eight (14.0%) reinterventions for inadequate symptom control compared with one (2.7%) among myomectomy patients (n = 37). Half of the women who required hysterectomy had concomitant adenomyosis missed by US. Conclusions: UAE and myomectomy both result in significant and equal improvements in QoL. UAE allows a shorter hospital stay and fewer major complications but with a higher rate of reintervention.

  3. Uterine artery embolisation versus hysterectomy for leiomyomas: primary and 2-year follow-up results of a randomised prospective clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Ruuskanen, Anu [Kuopio University Hospital, Department of Clinical Radiology, P.O. Box 1777, Kuopio (Finland); Hippelaeinen, Maritta [Kuopio University Hospital, Department of Obstetrics and Gynaecology, P.O. Box 1777, Kuopio (Finland); Sipola, Petri; Manninen, Hannu [Kuopio University Hospital, Department of Clinical Radiology, P.O. Box 1777, Kuopio (Finland); University of Eastern Finland, Faculty of Health Sciences, Institute of Clinical Medicine, P.O. Box 1627, Kuopio (Finland)

    2010-10-15

    To compare uterine artery embolisation (UAE) and hysterectomy for the treatment of leiomyomas at 2-year follow-up in a prospective, randomised, single-centre study. Fifty-seven symptomatic patients were randomised to UAE (n = 27) or hysterectomy (n = 30). Complications, recovery, reinterventions and satisfaction with treatment were recorded. Primary endpoint was improvement of symptoms. Analyses were performed by intent-to-treat and per protocol. Two hysterectomy patients (7%) developed major complications. Hospital discharge occurred earlier after UAE than after hysterectomy (p < 0.001). Length of sick leave was longer after hysterectomy than after UAE (p < 0.001). Twenty-two (82%) UAE patients and 28 (93%) hysterectomy patients reported overall relief of symptoms (p = 0.173). In 12/18 (67%) UAE patients menorrhagia was completely resolved or reduced. Improvement of pressure symptoms was reported significantly more by UAE patients than by hysterectomy patients (19/20 [95%] versus 18/26 [69%], respectively; p = 0.029). Five (19%) UAE patients underwent additional interventions due to worsening symptoms. Twenty-four (89%) UAE patients and 29 (97%) hysterectomy patients would have chosen treatment again (p = 0.336). UAE gave relief of symptoms (apart from menorrhagia) comparable to hysterectomy with less severe complications, but with an increased rate of secondary interventions. UAE may be the preferable treatment especially for patients with pressure symptoms. (orig.)

  4. Comparison of an Additional Transdermal Fentanyl Patch Compared to Intravenous NSAID and Opioid Analgesics within 24 Hours of an Uterine Artery Embolization for Myoma and Adenomyosis

    Energy Technology Data Exchange (ETDEWEB)

    Song, Suk Yun; Kang, Byung Chul; Rho, Kyung Min [Dept. of Radiology, Mokdong Hospital, Ewha Womans University School of Medicine, Seoul (Korea, Republic of)

    2011-05-15

    To evaluate the effectiveness of an additional transdermal fentanyl patch compared to intravenous analgesics in pain control during the 24-hour period following uterine artery embolization (UAE) for myoma and adenomyosis. Between September 2009 and August 2010, 42 patients underwent UAE for myoma or adenomyosis. Of these, 21 received an intravenous opioid (pethidine) and a nonsteroidal anti-inflammatory drug (group A), and 21 received an additional transdermal fentanyl patch (group B). Pain perception levels were established verbally on a 0-10 scale during the 24-hour period following UAE. Differences in pain trends, mean dose of intravenous pethidine, and adverse effects were compared between the two groups. Pain perception was most severe at 6 hours after UAE and the mean pain level of group B at that time was 6.3 {+-} 0.7, which was significantly lower than that of group A, 8.2 {+-} 0.7 (p<0.05). The mean dose of intravenous pethidine was 114.3 {+-} 59.5 mg in group A and 90.5 {+-} 49.0 mg in group B, while the incidence of nausea was 67% in group A and 77% in group B. In both cases, the differences were not significantly different (p>0.05), and no evidence of respiratory distress was demonstrated. The addition of a transdermal fentanyl patch to intravenous analgesics is effective in reducing post-embolization pain during the 24-hour period after UAE.

  5. Comparison of an Additional Transdermal Fentanyl Patch Compared to Intravenous NSAID and Opioid Analgesics within 24 Hours of an Uterine Artery Embolization for Myoma and Adenomyosis

    International Nuclear Information System (INIS)

    Song, Suk Yun; Kang, Byung Chul; Rho, Kyung Min

    2011-01-01

    To evaluate the effectiveness of an additional transdermal fentanyl patch compared to intravenous analgesics in pain control during the 24-hour period following uterine artery embolization (UAE) for myoma and adenomyosis. Between September 2009 and August 2010, 42 patients underwent UAE for myoma or adenomyosis. Of these, 21 received an intravenous opioid (pethidine) and a nonsteroidal anti-inflammatory drug (group A), and 21 received an additional transdermal fentanyl patch (group B). Pain perception levels were established verbally on a 0-10 scale during the 24-hour period following UAE. Differences in pain trends, mean dose of intravenous pethidine, and adverse effects were compared between the two groups. Pain perception was most severe at 6 hours after UAE and the mean pain level of group B at that time was 6.3 ± 0.7, which was significantly lower than that of group A, 8.2 ± 0.7 (p 0.05), and no evidence of respiratory distress was demonstrated. The addition of a transdermal fentanyl patch to intravenous analgesics is effective in reducing post-embolization pain during the 24-hour period after UAE.

  6. An economic evaluation of outpatient versus inpatient polyp treatment for abnormal uterine bleeding.

    Science.gov (United States)

    Diwakar, L; Roberts, T E; Cooper, N A M; Middleton, L; Jowett, S; Daniels, J; Smith, P; Clark, T J

    2016-03-01

    To undertake a cost-effectiveness analysis of outpatient uterine polypectomy compared with standard inpatient treatment under general anaesthesia. Economic evaluation carried out alongside the multi-centre, pragmatic, non-inferiority, randomised controlled Outpatient Polyp Treatment (OPT) trial. The UK National Health Service (NHS) perspective was used in the estimation of costs and the interpretation of results. Thirty-one secondary care UK NHS hospitals between April 2008 and July 2011. Five hundred and seven women with abnormal uterine bleeding and hysteroscopically diagnosed endometrial polyps. Outpatient uterine polypectomy versus standard inpatient treatment. Clinicians were free to choose the technique for polypectomy within the allocated setting. Patient-reported effectiveness of the procedure determined by the women's self-assessment of bleeding at 6 months, and QALY gains at 6 and 12 months. Inpatient treatment was slightly more effective but more expensive than outpatient treatment, resulting in relatively high incremental cost-effectiveness ratios. Intention-to-treat analysis of the base case at 6 months revealed that it cost an additional £9421 per successfully treated patient in the inpatient group and £ 1,099,167 per additional QALY gained, when compared with outpatient treatment. At 12 months, these costs were £22,293 per additional effectively treated patient and £445,867 per additional QALY gained, respectively. Outpatient treatment of uterine polyps associated with abnormal uterine bleeding appears to be more cost-effective than inpatient treatment at willingness-to-pay thresholds acceptable to the NHS. HTA-funded OPT trial concluded that outpatient uterine polypectomy is cost-effective compared with inpatient polypectomy. © 2015 Royal College of Obstetricians and Gynaecologists.

  7. Ulipristal acetate versus leuprolide acetate for uterine fibroids.

    Science.gov (United States)

    Donnez, Jacques; Tomaszewski, Janusz; Vázquez, Francisco; Bouchard, Philippe; Lemieszczuk, Boguslav; Baró, Francesco; Nouri, Kazem; Selvaggi, Luigi; Sodowski, Krzysztof; Bestel, Elke; Terrill, Paul; Osterloh, Ian; Loumaye, Ernest

    2012-02-02

    The efficacy and side-effect profile of ulipristal acetate as compared with those of leuprolide acetate for the treatment of symptomatic uterine fibroids before surgery are unclear. In this double-blind noninferiority trial, we randomly assigned 307 patients with symptomatic fibroids and excessive uterine bleeding to receive 3 months of daily therapy with oral ulipristal acetate (at a dose of either 5 mg or 10 mg) or once-monthly intramuscular injections of leuprolide acetate (at a dose of 3.75 mg). The primary outcome was the proportion of patients with controlled bleeding at week 13, with a prespecified noninferiority margin of -20%. Uterine bleeding was controlled in 90% of patients receiving 5 mg of ulipristal acetate, in 98% of those receiving 10 mg of ulipristal acetate, and in 89% of those receiving leuprolide acetate, for differences (as compared with leuprolide acetate) of 1.2 percentage points (95% confidence interval [CI], -9.3 to 11.8) for 5 mg of ulipristal acetate and 8.8 percentage points (95% CI, 0.4 to 18.3) for 10 mg of ulipristal acetate. Median times to amenorrhea were 7 days for patients receiving 5 mg of ulipristal acetate, 5 days for those receiving 10 mg of ulipristal acetate, and 21 days for those receiving leuprolide acetate. Moderate-to-severe hot flashes were reported for 11% of patients receiving 5 mg of ulipristal acetate, for 10% of those receiving 10 mg of ulipristal acetate, and for 40% of those receiving leuprolide acetate (P<0.001 for each dose of ulipristal acetate vs. leuprolide acetate). Both the 5-mg and 10-mg daily doses of ulipristal acetate were noninferior to once-monthly leuprolide acetate in controlling uterine bleeding and were significantly less likely to cause hot flashes. (Funded by PregLem; ClinicalTrials.gov number, NCT00740831.).

  8. The Manchester procedure versus vaginal hysterectomy in the treatment of uterine prolapse

    DEFF Research Database (Denmark)

    Tolstrup, Cæcilie Krogsgaard; Lose, Gunnar; Klarskov, Niels

    2017-01-01

    INTRODUCTION AND HYPOTHESIS: Uterine prolapse is a common health problem and the number of surgical procedures is increasing. No consensus regarding the surgical strategy for repair of uterine prolapse exists. Vaginal hysterectomy (VH) is the preferred surgical procedure worldwide, but uterus......-intervention rate, complications and operative outcomes. METHODS: We systematically searched Embase, PubMed, the Cochrane databases, Clinicaltrials and Clinical trials register using the MeSh terms "uterine prolapse", "uterus prolapse", "vaginal prolapse" "pelvic organ prolapse", "prolapsed uterus", "Manchester...... procedure" and "vaginal hysterectomy". No limitations regarding language, study design or methodology were applied. In total, nine studies published from 1966 to 2014 comparing the MP to VH were included. RESULTS: The anatomical recurrence rate for the middle compartment was 4-7 % after VH, whereas...

  9. Uterine endometrial stromal sarcoma located in uterine myometrium: MRI appearance

    Energy Technology Data Exchange (ETDEWEB)

    Ueda, M.; Otsuka, M.; Hatakenaka, M. [Dept. of Radiology, Medical Institute of Bioregulation, Kyushu University, Beppu (Japan); Torii, Y. [Dept. of Radiology, Saga Prefectural Hospital (Japan)

    2000-05-01

    Two cases of uterine endometrial stromal sarcoma whose main mass was located in uterine myometrium are reported. They mimicked uterine leiomyoma with cystic degeneration or uterine leiomyosarcoma. Endometrial stromal sarcoma should be suggested in the differential diagnosis of mass lesion in uterine myometrium. (orig.)

  10. Increased expression of electron transport chain genes in uterine leiomyoma.

    Science.gov (United States)

    Tuncal, Akile; Aydin, Hikmet Hakan; Askar, Niyazi; Ozkaya, Ali Burak; Ergenoglu, Ahmet Mete; Yeniel, Ahmet Ozgur; Akdemir, Ali; Ak, Handan

    2014-01-01

    The etiology and pathophysiology of uterine leiomyomas, benign smooth muscle tumors of the uterus, are not well understood. To evaluate the role of mitochondria in uterine leiomyoma, we compared electron transport gene expressions of uterine leiomyoma tissue with myometrium tissue in six uterine leiomyoma patients by RT-PCR array. Our results showed an average of 1.562 (±0.445) fold increase in nuclear-encoded electron transport genes. These results might suggest an increase in size, number, or activity of mitochondria in uterine leiomyoma that, to our knowledge, has not been previously reported. © 2014 by the Association of Clinical Scientists, Inc.

  11. Efficacy and patient satisfaction after NovaSure and Minerva endometrial ablation for treating abnormal uterine bleeding: a retrospective comparative study.

    Science.gov (United States)

    Scordalakes, Constantine; delRosario, Robert; Shimer, Andrew; Stankiewicz, Russell

    2018-01-01

    Compare amenorrhea rate, menstrual symptoms, patient satisfaction, and adverse events in women who underwent endometrial ablation with the NovaSure versus the Minerva radiofrequency ablation systems. We surveyed 189 premenopausal women (mean 40.8±6.2 years old) who underwent endometrial ablation for abnormal uterine bleeding using the NovaSure (n=97) or Minerva (n=92) systems, at four private US gynecology clinics, and whose procedure date was after July 2015 with follow-up ≥3 months. Women were surveyed an average of 11.3±3.9 months (range 137-532 days) after ablation. The subject-reported amenorrhea rate was 52% higher in NovaSure subjects than Minerva subjects (64% and 42%, respectively; p =0.004). Age and bleeding cyclicity did not affect amenorrhea rate in either group. Normal-to-no bleeding was reported by >90% of subjects after either treatment. NovaSure was significantly more effective than Minerva at reducing pad/tampon use in women with any residual bleeding (2.4±5.2 items/day versus 4.7±5.5 items/day, p =0.049). NovaSure was significantly more effective than Minerva at reducing premenstrual syndrome (PMS) symptoms ( p =0.019) and menstrual pain ( p =0.003), and more NovaSure subjects (94%) than Minerva subjects (78%) were satisfied with clinical outcomes ( p =0.003). Adverse events did not differ by treatment; three women in each group progressed to hysterectomy. While overall bleeding reduction in premenopausal women with abnormal uterine bleeding was excellent with either endometrial ablation system, NovaSure treatment resulted in a higher patient-reported 1-year amenorrhea rate, and women with residual bleeding used fewer pads and tampons than Minerva-treated women. Additionally, NovaSure subjects reported better menstrual-related life quality and PMS symptom alleviation, and greater satisfaction with outcomes than Minerva-treated women.

  12. Uterine sarcoma – current perspectives

    Science.gov (United States)

    Benson, Charlotte; Miah, Aisha B

    2017-01-01

    Uterine sarcomas comprise a group of rare tumors with differing tumor biology, natural history and response to treatment. Diagnosis is often made following surgery for presumed benign disease. Currently, preoperative imaging does not reliably distinguish between benign leiomyomas and other malignant pathology. Uterine leiomyosarcoma is the most common sarcoma, but other subtypes include endometrial stromal sarcoma (low grade and high grade), undifferentiated uterine sarcoma and adenosarcoma. Clinical trials have shown no definite survival benefit of adjuvant radiotherapy or chemotherapy and have been hampered by the rarity and heterogeneity of these disease types. There is a role of adjuvant treatment in carefully selected cases following multidisciplinary discussion at sarcoma reference centers. In patients with metastatic disease, systemic chemotherapy can then be considered. There is activity of a number of agents, including doxorubicin, trabectedin, gemcitabine-based chemotherapy, eribulin and pazopanib. Patients should be considered for clinical trial entry where possible. Close international collaboration is important to allow progress in this group of diseases. PMID:28919822

  13. Decision on performing interim analysis for comparative clinical trials.

    Science.gov (United States)

    Pak, Kyongsun; Jacobus, Susanna; Uno, Hajime

    2017-09-01

    In randomized-controlled trials, interim analyses are often planned for possible early trial termination to claim superiority or futility of a new therapy. While unblinding is necessary to conduct the formal interim analysis in blinded studies, blinded data also have information about the potential treatment difference between the groups. We developed a blinded data monitoring tool that enables investigators to predict whether they observe such an unblinded interim analysis results that supports early termination of the trial. Investigators may skip some of the planned interim analyses if an early termination is unlikely. We specifically focused on blinded, randomized-controlled studies to compare binary endpoints of a new treatment with a control. Assuming one interim analysis is planned for early termination for superiority or futility, we conducted extensive simulation studies to assess the impact of the implementation of our tool on the size, power, expected number of interim analyses, and bias in the treatment effect. The numerical study showed the proposed monitoring tool does not affect size or power, but dramatically reduces the expected number of interim analyses when the effect of the treatment difference is small. The tool serves as a useful reference when interpreting the summary of the blinded data throughout the course of the trial, without losing integrity of the study. This tool could potentially save the study resources and budget by avoiding unnecessary interim analyses.

  14. DNA level and stereologic estimates of nuclear volume in squamous cell carcinomas of the uterine cervix. A comparative study with analysis of prognostic impact

    DEFF Research Database (Denmark)

    Sørensen, Flemming Brandt; Bichel, P; Jakobsen, A

    1992-01-01

    Grading of malignancy in squamous cell carcinomas of the uterine cervix is based on qualitative, morphologic examination and suffers from poor reproducibility. Using modern stereology, unbiased estimates of the three-dimensional, volume-weighted mean nuclear volume (nuclear vv), were obtained...... in pretreatment biopsies from 51 patients treated for cervical cancer in clinical Stages I through III (mean age of 56 years, follow-up period greater than 5 years). In addition, conventional, two-dimensional morphometric estimates of nuclear and mitotic features were obtained. DNA indices (DI) were estimated...... carcinoma of the uterine cervix....

  15. The management of uterine leiomyomas.

    Science.gov (United States)

    Vilos, George A; Allaire, Catherine; Laberge, Philippe-Yves; Leyland, Nicholas

    2015-02-01

    The aim of this guideline is to provide clinicians with an understanding of the pathophysiology, prevalence, and clinical significance of myomata and the best evidence available on treatment modalities. The areas of clinical practice considered in formulating this guideline were assessment, medical treatments, conservative treatments of myolysis, selective uterine artery occlusion, and surgical alternatives including myomectomy and hysterectomy. The risk-to-benefit ratio must be examined individually by the woman and her health care provider. Implementation of this guideline should optimize the decision-making process of women and their health care providers in proceeding with further investigation or therapy for uterine leiomyomas, having considered the disease process and available treatment options, and reviewed the risks and anticipated benefits. Published literature was retrieved through searches of PubMed, CINAHL, and Cochrane Systematic Reviews in February 2013, using appropriate controlled vocabulary (uterine fibroids, myoma, leiomyoma, myomectomy, myolysis, heavy menstrual bleeding, and menorrhagia) and key words (myoma, leiomyoma, fibroid, myomectomy, uterine artery embolization, hysterectomy, heavy menstrual bleeding, menorrhagia). The reference lists of articles identified were also searched for other relevant publications. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date limits but results were limited to English or French language materials. Searches were updated on a regular basis and incorporated in the guideline to January 2014. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, and national and international medical specialty societies. The majority of fibroids are asymptomatic and require no intervention or further

  16. Is a history of cesarean section a risk factor for abnormal uterine bleeding in patients with uterine leiomyoma?

    Science.gov (United States)

    Kinay, Tugba; Basarir, Zehra O; Tuncer, Serap F; Akpinar, Funda; Kayikcioglu, Fulya; Koc, Sevgi; Karakaya, Jale

    2016-08-01

    To determine whether a history of cesarean section was a risk factor for abnormal uterine bleeding in patients with uterine leiomyomas, and to identify other risk factors for this symptom. We analyzed retrospectively, the medical records of patients who underwent hysterectomies due to the presence of uterine leiomyomas during a 6-year period (2009 and 2014) at Etlik Zubeyde Hanim Women's Health Training and Research Hospital, Ankara, Turkey. Uterine leiomyoma was diagnosed based on histopathological examination of hysterectomy specimens. Demographic characteristics, and laboratory and histopathological findings were compared between patients with uterine leiomyoma with and without abnormal uterine bleeding. In total, 501 (57.9%) patients had abnormal uterine bleeding and 364 (42.1%) patients had other symptoms. A history of cesarean section was more common in patients with abnormal uterine bleeding than in those with other symptoms (17.6% versus 9.3%, p=0.001; odds ratio [OR]: 2.1; 95% confidence interval [CI]: 1.4-3.3). The presence of a submucosal leiomyoma (OR: 2.1; 95% CI: 1.5-3.1) and coexistent adenomyosis (OR: 1.6; 95% CI: 1.1-2.4) were also associated with abnormal uterine bleeding. A history of cesarean section was an independent risk factor for abnormal uterine bleeding in patients with uterine leiomyomas; submucosal leiomyoma and coexisting adenomyosis were also independent risk factors.

  17. Phase II Trial of Adjuvant Pelvic Radiation “Sandwiched” Between Combination Paclitaxel and Carboplatin in Women with Uterine Papillary Serous Carcinoma

    Science.gov (United States)

    Einstein, Mark H.; Frimer, Marina; Kuo, Dennis Y-S; Reimers, Laura L.; Mehta, Keyur; Mutyala, Subhakar; Huang, Gloria S.; Hou, June Y.; Goldberg, Gary L.

    2013-01-01

    Objective To evaluate the safety and survival in women treated with adjuvant pelvic radiation “sandwiched” between six cycles of paclitaxel and carboplatin chemotherapy with completely resected UPSC. Methods Surgically staged women with UPSC (FIGO stage 1-4) and no visible residual disease were enrolled. Treatment involved paclitaxel (175 mg/m2) and carboplatin (AUC=6.0-7.5) every 21 days for 3 doses, followed by radiation therapy (RT), followed by an additional 3 cycles of paclitaxel and carboplatin (AUC=5-6). Survival analysis, using Kaplan-Meier methods, was performed on patients who completed at least 3 cycles of chemotherapy and RT. Results A total of 81 patients were enrolled, of which 72 patients completed the first 3 cycles of chemotherapy followed by prescribed RT. Median age was 67 years (range: 43–82 years). 59/72 (82%) had disease confined to the uterus and 13/72 (18%) had completely resected extra-uterine disease (stage 3&4). 65 (83%) completed the protocol. Overall PFS and OS for combined stage 1&2 patients was 65.5±3.6 months and 76.5±4.3 months, respectively. PFS and OS for combined stage 3&4 patients was 25.8±3.0 and 35.9±5.3 months, respectively. Three-year % survival probability for stage 1&2 patients was 84% and for stage 3&4 patients was 50%. Of the 435 chemotherapy cycles administered, there were 11(2.5%) G3/G4 non-hematologic toxicities. 26(6.0%) cycles had dose reductions and 37(8.5%) had dose delays. Conclusions Compared to prior studies of single modality adjuvant therapy, RT “sandwiched” between paclitaxel and carboplatin chemotherapy is well-tolerated and highly efficacious in women with completely resected UPSC. PMID:22035806

  18. Laparoscopic uterine surgery as a risk factor for uterine rupture during pregnancy.

    Science.gov (United States)

    Chao, An-Shine; Chang, Yao-Lung; Yang, Lan-Yan; Chao, Angel; Chang, Wei-Yang; Su, Sheng-Yuan; Wang, Chin-Jung

    2018-01-01

    The incidence of uterine rupture through a previous cesarean scar (CS) is declining as a result of a lower parity and fewer options for vaginal birth after cesarean. However, uterine ruptures attributable to other causes that traumatize the myometrium are on the rise. To determine whether changes in the causes of uterine rupture had occurred in recent years, we retrospective retrieved the clinical records of all singletons with uterine rupture observed in the delivery room of a Taiwanese tertiary obstetric center over a 15-year period. The overall uterine rupture rate was 3.8 per 10,000 deliveries. A total of 22 cases in 20 women (with two of them experiencing two episodes). Seven uterine ruptures occurred through a previous cesarean scar (CS ruptures, 32%), 13 through a non-cesarean scar (non-CS ruptures, 59%), whereas the remaining two (9%) were in women who did not previously undergo any surgery. All of the 13 non-CS ruptures were identified in women with a history of laparoscopic procedures to the uterus. Specifically, 10 (76%) occurred after a previous laparoscopic myomectomy, one (8%) following a hysteroscopic myomectomy, and two (16%) after a laparoscopic wedge resection of cornual ectopic pregnancy. Severe bleeding (blood loss >1500 mL) requiring transfusions was more frequent in women who experienced non-CS compared with CS ruptures (10 versus 1 case, respectively, P = 0.024). Patients with a history of endoscopic uterine surgery should be aware of uterine rupture during pregnancy.

  19. Laparoscopic uterine surgery as a risk factor for uterine rupture during pregnancy

    Science.gov (United States)

    Chao, An-Shine; Chang, Yao-Lung; Yang, Lan-Yan; Chao, Angel; Chang, Wei-Yang; Su, Sheng-Yuan

    2018-01-01

    The incidence of uterine rupture through a previous cesarean scar (CS) is declining as a result of a lower parity and fewer options for vaginal birth after cesarean. However, uterine ruptures attributable to other causes that traumatize the myometrium are on the rise. To determine whether changes in the causes of uterine rupture had occurred in recent years, we retrospective retrieved the clinical records of all singletons with uterine rupture observed in the delivery room of a Taiwanese tertiary obstetric center over a 15-year period. The overall uterine rupture rate was 3.8 per 10,000 deliveries. A total of 22 cases in 20 women (with two of them experiencing two episodes). Seven uterine ruptures occurred through a previous cesarean scar (CS ruptures, 32%), 13 through a non-cesarean scar (non-CS ruptures, 59%), whereas the remaining two (9%) were in women who did not previously undergo any surgery. All of the 13 non-CS ruptures were identified in women with a history of laparoscopic procedures to the uterus. Specifically, 10 (76%) occurred after a previous laparoscopic myomectomy, one (8%) following a hysteroscopic myomectomy, and two (16%) after a laparoscopic wedge resection of cornual ectopic pregnancy. Severe bleeding (blood loss >1500 mL) requiring transfusions was more frequent in women who experienced non-CS compared with CS ruptures (10 versus 1 case, respectively, P = 0.024). Patients with a history of endoscopic uterine surgery should be aware of uterine rupture during pregnancy. PMID:29787604

  20. Laparoscopic uterine surgery as a risk factor for uterine rupture during pregnancy.

    Directory of Open Access Journals (Sweden)

    An-Shine Chao

    Full Text Available The incidence of uterine rupture through a previous cesarean scar (CS is declining as a result of a lower parity and fewer options for vaginal birth after cesarean. However, uterine ruptures attributable to other causes that traumatize the myometrium are on the rise. To determine whether changes in the causes of uterine rupture had occurred in recent years, we retrospective retrieved the clinical records of all singletons with uterine rupture observed in the delivery room of a Taiwanese tertiary obstetric center over a 15-year period. The overall uterine rupture rate was 3.8 per 10,000 deliveries. A total of 22 cases in 20 women (with two of them experiencing two episodes. Seven uterine ruptures occurred through a previous cesarean scar (CS ruptures, 32%, 13 through a non-cesarean scar (non-CS ruptures, 59%, whereas the remaining two (9% were in women who did not previously undergo any surgery. All of the 13 non-CS ruptures were identified in women with a history of laparoscopic procedures to the uterus. Specifically, 10 (76% occurred after a previous laparoscopic myomectomy, one (8% following a hysteroscopic myomectomy, and two (16% after a laparoscopic wedge resection of cornual ectopic pregnancy. Severe bleeding (blood loss >1500 mL requiring transfusions was more frequent in women who experienced non-CS compared with CS ruptures (10 versus 1 case, respectively, P = 0.024. Patients with a history of endoscopic uterine surgery should be aware of uterine rupture during pregnancy.

  1. A randomized trial comparing treatments for varicose veins.

    Science.gov (United States)

    Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; Francis, Jill; Tassie, Emma; Scotland, Graham; Wileman, Samantha; Campbell, Marion K

    2014-09-25

    Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain. In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success. After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (Pdisease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

  2. CT differentiation of solid ovarian tumor and uterine subserosal leiomyoma

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Kyung Rae; Cho, Kyoung Sik [Asan Medical Center, Ulsan Univ. College of Medicine, Seoul (Korea, Republic of); Sohn, Chul Ho [Dongsan Medical Center, Keimyung Univ. College of Medicine, Taegu (Korea, Republic of); Ji, Eun Kyung [Bombit Hospital, Seoul (Korea, Republic of)

    1999-06-01

    On the basis of CT findings, to differentiate between solid ovarian tumor and uterine subserosal myoma. In eight surgically proven cases of solid ovarian tumor and in ten uterine subserosal myoma patients, contrast-enhanced CT images were obtained. Two genitourinary radiologists reviewed the findings with regard to degree of enhancement of the mass as compared with enhancement of uterine myometrium, thickening of round ligaments, visualization of normal ovaries, contour of the mass, and the presence of ascites in the pelvic cavity. Six of eight ovarian tumors but only two of ten uterine myomas were less enhanced than normal uterine myometrium (p<0.05). Pelvic ascites were seen in six of eight ovarian tumors, but in only one of ten uterine myomas (P<0.05). Three of 16 ovaries in ovarian tumor patients, but 12 of 20 ovaries in uterine myoma patients, were normal (p<0.05). Six of 16 round ligaments of the uterus in ovarian tumor patients, were thichened but 11 of 20 round ligaments in uterine myoma patients, were thickened (p>0.05). The contour of the mass was lobulated in two of eight ovarian tumor patients, but in five of ten uterine myoma patients (p>0.05). CT findings suggestive of solid ovarian tumor were less contrast enhancement of the mass than of normal uterine myometrium, pelvic ascites, and nonvisualization of normal ovary.

  3. Uterine Cancer—Patient Version

    Science.gov (United States)

    Uterine cancers can be of two types: endometrial cancer (common) and uterine sarcoma (rare). Endometrial cancer can often be cured. Uterine sarcoma is often more aggressive and harder to treat. Start here to find information on uterine cancer treatment, causes and prevention, screening, research, and statistics.

  4. Early stage cervical cancer of the uterine

    International Nuclear Information System (INIS)

    Kaneyasu, Yuuko; Fujiwara, Hisaya

    2011-01-01

    This paper describes the present state of radiotherapy (RT) of early stage cervical cancer involving the history, outcomes of clinical trials, procedure for each stage, irradiation methods, concurrent chemo-RT (CCRT), late adverse events, and QOL after RT. It has a history of >100 years from the brachytherapy with radium, but is not yet completely established even now. There are many RT trials hitherto. Retrospectively, no significant difference is seen in outcomes of radical RT and surgery: 80-90% efficacy for stage I and 60-80% for II in the former, respectively, and 80-96% and 65-80%, in the latter. Between RT and surgery, there is a report of randomized comparative study in Italy. In Japan, reported are comparative outcomes based on patients' choice for therapy, retrospective studies including authors' one, prospective multi-institutional cooperative trials by Japanese Radiation Oncology Study Group, and Treatment Guidelines for Cervical Cancer (2007). RT procedure depends on the stage defined by FIGO (International Federation of Gynecology and Obstetrics) and at stages I-II, intracavitary RT is major with optimal dose 29 Gy/5 fractions for I, and 23/4 Gy with external total pelvic radiation 50 Gy for II. In external radiation, the planning target volume includes the whole pelvic field with 1.8-2 Gy/5 weeks and optionally, the extended field when metastasis suspicious. Intracavitary RT with application device in the uterine is of significance for the cancer as 50% complete cure even in stage III is reported. CCRT brings about good prognosis, which is shown in a Japanese trial to compare postoperative RT alone and CCRT with CDDP and 5-FU. The late adverse events are seen mainly in the large bowel and studies of QOL, an important factor for choice of treatment, are now in progress. (T.T.)

  5. Expression and prognostic value of lactate dehydrogenase-A and -D subunits in human uterine myoma and uterine sarcoma.

    Science.gov (United States)

    Song, Ke-Juan; Yu, Xiao-Ni; Lv, Teng; Chen, Yu-Long; Diao, Yu-Chao; Liu, Su-Li; Wang, Yan-Kui; Yao, Qin

    2018-04-01

    This study aimed to determine the expression of lactate dehydrogenase (LDH)-A and LDH-D in patients with uterine myoma, cellular leiomyoma (CLM), and uterine sarcoma and to evaluate their prognostic significance. Protein expression levels of LDH-A and LDH-D were determined in tissue samples from 86 patients (26 uterine myoma, 10 CLM, 50 uterine sarcoma) by immunohistochemistry and their associations with clinicopathologic parameters and outcomes were analyzed in patients with uterine sarcoma. The positivity rates for LDH-A and LDH-D were significantly higher in patients with uterine sarcoma compared with those with uterine myoma or CLM (P sarcoma were classified as having uterine leiomyosarcoma (LMS), malignant endometrial stromal sarcoma, and malignant mixed Mullerian tumor, with 5-year overall survival rates of 59%, 71%, and 29%, respectively (P sarcoma. Furthermore, the overexpressions of LDH-A and LDH-D in uterine sarcoma patients may contribute to further understanding of the mechanism of LDH in tumor metabolism in uterine sarcoma. Positive expression of LDH-A in patients with LMS may act as a potential prognostic biomarker in these patients.

  6. Role of bevacizumab in uterine leiomyosarcoma.

    Science.gov (United States)

    Bogani, Giorgio; Ditto, Antonino; Martineli, Fabio; Signorelli, Mauro; Chiappa, Valentina; Fonatella, Caterina; Sanfilippo, Roberta; Leone Roberti Maggiore, Umberto; Ferrero, Simone; Lorusso, Domenica; Raspagliesi, Francesco

    2018-06-01

    In the recent years, angiogenetic inhibitors have emerged for the treatment of several malignancies. In particular, bevacizumab has proved to be effective in many types of cancers (including sarcoma), but the limitations of antiangiogenic therapy have been shown in practice. Here, we sought to review the current evidence on the role and efficacy of bevacizumab in patients affected by uterine leiomyosarcoma. On April 2017, Literature was searched in order to identify studies reporting outcomes of patients affected either by early stage or advanced/recurred uterine leiomyosarcoma undergoing treatment with bevacizumab, alone or in combination with other chemotherapeutic regimens. Searching the literature data of 69 patients affected by metastatic, unresectable uterine leiomyosarcoma were retrieved; on the contrary, no data regarding the use of bevacizumab in patients with early-stage uterine leiomyosarcoma was published. Current evidence suggested that the addiction of bevacizumab to standard treatment modality does not increase grade 3 or worse toxicity (assessed by CTCAE). Pooled data regarding response rate suggested that 35%, 28%, 26% and 11% of patients experienced objective cure (complete + partial response), stable disease, progressive disease and unknown response, respectively. Data from the only one randomized controlled trial suggested that objective cure rate does not differ from standard chemotherapy treatment, thus limiting the indication to add bevacizumab in patients affected by metastatic, unresectable uterine leiomyosarcoma. The current evidence does not justify the use of bevacizumab into clinical practice. Further randomized studies testing the role of bevacizumab are warranted. Copyright © 2018 Elsevier B.V. All rights reserved.

  7. Complications Associated with Uterine Artery Embolisation for Fibroids

    Directory of Open Access Journals (Sweden)

    Maria Memtsa

    2012-01-01

    Full Text Available Uterine artery embolisation (UAE is a relative newcomer to the mainstream treatment modalities available for fibroid-related problems. The efficacy of UAE is indisputable and has been shown to be comparable to hysterectomy in the short term in large-scale trials. Moreover, compared with hysterectomy, UAE is less invasive, carries a superior risk profile, and, importantly, preserves the uterus. UAE therefore offers patients symptom relief whilst at the same time retaining reproductive potential. Notably however, although women can have successful pregnancies following UAE, it is becoming increasingly evident that pregnancies after UAE are more risky especially during the early stages. Long-term outcome data from randomised trials involving UAE have very recently become available and show that whilst high satisfaction rates previously identified during early-stage followup are sustained, one notable drawback is a substantial risk of reintervention. It remains to be seen how this facet of UAE will impact on its future uptake.

  8. Uterine artery embolisation for uterine leiomyomas

    African Journals Online (AJOL)

    The presenting symptoms were menorrhagia, dysmenorrhoea, pressure symptoms and intermenstrual bleeding. Three women were treated for primary infertility. Uterine artery sub-selection and embolisation was successful in all patients. Complications included low-grade pyrexia (3/36, 8.3%) and readmission (1/36, 2.8%).

  9. Uterine Leiomyoma: Hysterosalpingographic Appearances

    Directory of Open Access Journals (Sweden)

    Firoozeh Ahmadi

    2008-01-01

    Full Text Available Uterine leiomyoma is the most common benign tumor of genital tract. The etiology of myomasis unknown. Leiomyoma shows a broad spectrum of radiographic appearances depending on thenumber, size, and location of the tumor. The diagnostic method for uterine leiomyomas is basedprimarily on the clinical situation. Despite of the varied diagnostic options such as; transvaginalsonography, sonohysterography, hysteroscopy, laparoscopy and MRI; hysterosalpingography isstill one of the valuable imaging methods for identification of uterine leiomyoma.The various features of the proved leiomyoma are illustrated in this pictorial review. The incidence,risk factors and clinical features will also be discussed briefly.

  10. Uterine Fibroid Embolization (UFE)

    Science.gov (United States)

    ... or gynecologist. top of page What are the benefits vs. risks? Benefits Uterine fibroid embolization, done under local anesthesia , is ... risk of infection. The chance of infection requiring antibiotic treatment appears to be less than one in ...

  11. Uterine Leiomyomas: An ENIGMA

    Directory of Open Access Journals (Sweden)

    Kempula Geethamala

    2016-01-01

    Conclusion: Though hysterectomy is a routine procedure in the management of uterine leiomyomas, occasional cases of tumor or infective pathology may be missed. Therefore, histopathology is mandatory and conscientious quest must be done for confirmed diagnosis and ensuring optimal management.

  12. Uterine Cancer Statistics

    Science.gov (United States)

    ... Doing AMIGAS Stay Informed Cancer Home Uterine Cancer Statistics Language: English (US) Español (Spanish) Recommend on Facebook ... the most commonly diagnosed gynecologic cancer. U.S. Cancer Statistics Data Visualizations Tool The Data Visualizations tool makes ...

  13. The clinical application of uterine arterial embolization with dextran microspheres in treating uterine leiomyomas

    International Nuclear Information System (INIS)

    Xu Qiang; Huang Youhua; Shi Hongjian; Shen Tao; Zhou Huaming; Wu Xiaosong; Jiang Lei; Chen Jing; Chu Jumei

    2011-01-01

    Objective: To prospectively investigate the clinical application of bilateral uterine arterial embolization with dextran microspheres in treating uterine leiomyomas. Methods: A total of 60 patients with uterine leiomyomas, encountered in the authors' hospital during the period from Jan. 2003 to Dec. 2010, were enrolled in this study. The patients were randomly divided into study group and control group with 30 cases in each group. Patients in the study group received bilateral uterine artery embolization by using dextran microspheres (Sephadex, g-50, 100-300 μm) as embolic agents, while patients in control group received bilateral uterine artery embolization by using KMG (500-700 μm) as embolic agents. Before and after the treatment, all patients were kept under observation for the menstrual flow, the size of the uterine and the leiomyoma and the changes in sex hormone level. The hospitalization costs were recorded. The results were compared between the two groups. Results: The technical success rate of catheterization and embolization procedure was 100% in both groups. After the therapy, the volumes of both the uterine and the leiomyoma were significantly decreased, but no significant difference in the size reduction existed between the two groups (both P.0.05). The clinical symptoms were markedly improved in all patients. The sex hormone level showed no obvious changes. No serious complications occurred. The hospitalization cost of the study group was significantly lower than that of the control group (P<0.05). Conclusion: For the treatment of uterine leiomyomas, uterine artery embolization with dextran microspheres is very effective and safe. Moreover, the hospitalization cost is lower. Therefore, it is of value to use this technique in clinical practice. (authors)

  14. Trial of labor compared to repeat cesarean section in women with no other risk factors than a prior cesarean delivery

    DEFF Research Database (Denmark)

    Studsgaard, Anne; Skorstengaard, Malene; Glavind, Julie

    2013-01-01

    OBJECTIVE: To compare outcomes with trial of labor after cesarean (TOLAC) or elective repeat cesarean delivery on maternal request (ERCD-MR). DESIGN: Prospective cohort study. SETTING: Danish university hospital. POPULATION: Women with TOLAC (n = 1161) and women with ERCD-MR (n = 622) between 2003...... registration of the deliveries. MAIN OUTCOME MEASURES: Adverse neonatal outcomes, risk factors for emergency cesarean, and uterine rupture in case of TOLAC. RESULTS: TOLAC was associated with an increased risk of neonatal depression [odds ratio (OR) 3.6, 95% confidence interval (CI) 1.1-19.1] and neonatal...... vaginal delivery (adjusted OR 1.8, 95% CI 1.1-3.0), index emergency cesarean during labor (adjusted OR 3.0, 95% CI 2.3-4.1), maternal age ≥35 years (adjusted OR 1.9, 95% CI 1.3-2.8), pre-pregnancy body mass index ≥30 (adjusted OR 2.1, 95% CI 1.3-3.3), and birthweight 4000-4499 g (adjusted OR 1.5, 95% CI 1...

  15. Comparing abrupt and gradual smoking cessation: a randomized trial.

    Science.gov (United States)

    Etter, Jean-François

    2011-11-01

    To compare abrupt and gradual smoking cessation. Randomized trial and observational study, Internet, 2007-2010. Smokers with no strong preference for abrupt or gradual quitting were randomly assigned to quitting immediately (n=472), or to gradually reducing their cigarette consumption over 2 weeks and then quit (n=502). Smokers who strongly preferred to quit abruptly were instructed to do so immediately (n=2456), those who strongly preferred gradual were instructed to reduce their cigarette consumption over 2 weeks, then quit (n=1801). Follow-up was conducted 4 weeks after target quit dates. Those who preferred abrupt quitting were the most motivated to quit and the most confident in their ability to quit. At follow-up, quit rates were 16% in those who preferred abrupt cessation, 7% in those who preferred gradual cessation and 9% in those who had no preference (pmotivation to quit and confidence in ability to quit: those who had low levels of motivation or low levels of confidence were more likely to quit at follow-up if they preferred and used abrupt rather than gradual. In those who had no strong preference for either method, abrupt and gradual produced similar results. Those who preferred and used the abrupt method were more likely to quit than those who preferred and used the gradual method, in particular when they had low motivation and confidence. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  16. DNA level and stereologic estimates of nuclear volume in squamous cell carcinomas of the uterine cervix. A comparative study with analysis of prognostic impact

    DEFF Research Database (Denmark)

    Sørensen, Flemming Brandt; Bichel, P; Jakobsen, A

    1992-01-01

    Grading of malignancy in squamous cell carcinomas of the uterine cervix is based on qualitative, morphologic examination and suffers from poor reproducibility. Using modern stereology, unbiased estimates of the three-dimensional, volume-weighted mean nuclear volume (nuclear vv), were obtained...... in pretreatment biopsies from 51 patients treated for cervical cancer in clinical Stages I through III (mean age of 56 years, follow-up period greater than 5 years). In addition, conventional, two-dimensional morphometric estimates of nuclear and mitotic features were obtained. DNA indices (DI) were estimated...

  17. Clinical trial of osteoarthritis jamu formula compare to piroxicam

    Directory of Open Access Journals (Sweden)

    Danang Ardiyanto

    2016-12-01

    is a lack of evidence of its efficacy and safety. The objectives of study were to investigate the efficacy and safety of  a traditional formula for OA. Methods: Design of the study was a randomized clinical trial (RCT involved 123 patients (subjects for 28 days intervention. This study was conducted between March - December 2014 with 30 physicians were participated at 20 regencies in Indonesia. The variables measured were VAS score, PGAP functional status assessment (FSA, and Short Form (SF-36 to assess jamu efficacy in comparison to piroxicam. To evaluate the safety of jamu formula using values of SGOT, SGPT, BUN, and creatinine. Result: The jamu formula administration effects can reduce VAS significantly  (p<0.05  if it was compared to baseline. FSA score of jamu formula group was decreased significantly (p=0.000 when compared to the start of intervention. Short Form (SF-36 of jamu formula group were significantly improved when compared with baseline value. The result of the three parameters between jamu group and piroxicam group should not significantly different. There was no difference in those parameters between both groups (p>0.05. In biological parameters, SGPT, SGOT, BUN, and creatinine level, showed normal range in both groups. Conclusion: This study showed that the efficacy and safety of jamu formula was clinically comparable to piroxicam after 28 days of treatment. Keywords: efficacy, safety, RCT, jamu formula  

  18. A systematic review on efficacy and safety of gasless laparoscopy in the management of uterine leiomyoma.

    Science.gov (United States)

    Liu, Qi-wei; Han, Tong; Yang, Min; Tong, Xiao-wen; Wang, Jian-jun

    2016-02-01

    Uterine leiomyoma causes considerable morbidity in women. This study systematically reviewed the efficacy and safety of gasless laparoscopic myomectomy (GLM) in the management of uterine leiomyoma by comparing GLM with other minimally invasive procedures. Cochrane Library, Pub- Med, EMBASE, Web of Science, WANFANG database and China National Knowledge Infrastructure (CNKI) were searched for studies published in English or Chinese between January 1995 and May 2015, and related references were traced. Study outcomes from randomized controlled trials and retrospective cohort studies were presented as mean difference (MD) or odds ratio (OR) with a 95% confidence interval (CI). Seventeen studies (including 1862 patients) meeting the inclusion criteria, including 934 treated with GLM and 928 treated with other minimally invasive procedures were reviewed. The results of meta-analysis revealed that GLM resulted in significantly shorter operating time [MD=-10.34, 95% CI (-18.12,-2.56), Ppost-operative fever [MD=-0.52, 95% CI (-1.46, 0.42)] between the two groups. Additionally, GLM was associated with lower febrile morbidity, lower postoperative abdominal pain, and higher postoperative hemoglobin than other minimally invasive procedures for the treatment of uterine leiomyoma. In conclusion, GLM and other minimally invasive procedures are feasible, safe, and reliable for uterine leiomyoma treatment. However, available studies show that GLM is more effective and safer than other minimally invasive approaches.

  19. Tratamento do abortamento incompleto por aspiração manual ou curetagem Comparative study of manual vacuum aspiration and uterine curettage for treatment of abortion

    Directory of Open Access Journals (Sweden)

    Pedro Paulo Pereira

    2006-10-01

    Full Text Available OBJETIVOS: Comparar aspiração manual intra-uterina (AMIU com curetagem uterina (D&C em abortamentos no primeiro trimestre no que se refere a eficiência para eliminar restos ovulares do método de aspiração manual intra-uterina com a dilatação e curetagem, ocorrência de complicações (perfuração uterina, laceração cervical, hemorragia pós-tratamento, tempo duração dos procedimentos e tempo de internação das pacientes. MÉTODOS: Cinqüenta pacientes no grupo AMIU e 50 pacientes no grupo D&C foram incluídas prospectivamente de maneira aleatória. Critérios de inclusão: abortamento espontâneo, idade gestacional de até 13 semanas, colo pérvio, espessura endometrial maior que 15 mm, estado afebril, hemoglobina superior a 10 g/dl. Amostras sangüíneas foram colhidas antes e após os procedimentos cirúrgicos para controle dos níveis de hemoglobina; anestesia foi realizada em todos os casos. O tempo para realização de cada procedimento cirúrgico foi cronometrado. RESULTADOS: Os grupos eram semelhantes quanto à idade gestacional (9,93±2,40; 9,73±2,58, p 0,71, espessura endometrial antes da cirurgia (22,14±4,80; 22,68±5,68, p 0,65. Não foram observadas complicações cirúrgicas ou anestésicas em nenhum grupo. Os tempos de realização do procedimento e internação foram significativamente menores nas pacientes do grupo AMIU (3,71; 10,18 min, p OBJECTIVES: To compare manual vacuum aspiration (MVA and uterine curettage (D&C for first trimester abortions, in terms of the efficiency of eliminating ovular remnants, frequency of complications, duration of the procedure, and duration of patients' hospitalization. METHODS: In a prospective study, 50 patients in the MVA group and 50 in the D&C group were randomly included. Inclusion criteria were: spontaneous abortion, gestational age less than 13 weeks, patent cervix, endometrial thickness >15 mm, afebrile state, and hemoglobin >10 g/dl. Blood samples were collected before

  20. Identification of Distant Metastatic Disease in Uterine Cervical and Endometrial Cancers with FDG PET/CT: Analysis from the ACRIN 6671/GOG 0233 Multicenter Trial.

    Science.gov (United States)

    Gee, Michael S; Atri, Mostafa; Bandos, Andriy I; Mannel, Robert S; Gold, Michael A; Lee, Susanna I

    2018-04-01

    Purpose To assess the accuracy of staging positron emission tomography (PET)/computed tomography (CT) in detecting distant metastasis in patients with local-regionally advanced cervical and high-risk endometrial cancer in the clinical trial by the American College of Radiology Imaging Network (ACRIN) and the Gynecology Oncology Group (GOG) (ACRIN 6671/GOG 0233) and to compare central and institutional reader performance. Materials and Methods In this prospective multicenter trial, PET/CT and clinical data were reviewed for patients enrolled in ACRIN 6671/GOG 0233. Two central readers, blinded to site read and reference standard, reviewed PET/CT images for distant metastasis. Central review was then compared with institutional point-of-care interpretation. Reference standard was pathologic and imaging follow-up. Test performance for central and site reviews of PET/CT images was calculated and receiver operating characteristic analysis was performed. Generalized estimating equations and nonparametric bootstrap procedure for clustered data were used to assess statistical significance. Results There were 153 patients with cervical cancer and 203 patients with endometrial cancer enrolled at 28 sites. Overall prevalence of distant metastasis was 13.7% (21 of 153) for cervical cancer and 11.8% (24 of 203) for endometrial cancer. Central reader PET/CT interpretation demonstrated sensitivity, specificity, positive predictive value (PPV), and negative predictive value of 54.8%, 97.7%, 79.3%, and 93.1% for cervical cancer metastasis versus 64.6%, 98.6%, 86.1%, and 95.4% for endometrial cancer, respectively. By comparison, local institutional review demonstrated sensitivity, specificity, PPV, and negative predictive value of 47.6%, 93.9%, 55.6%, and 91.9% for cervical cancer metastasis and 66.7%, 93.9%, 59.3%, and 95.5% for endometrial cancer, respectively. For central readers, the specificity and PPV of PET/CT detection of cervical and endometrial cancer metastases were all

  1. Acute puerperal uterine inversion

    International Nuclear Information System (INIS)

    Hussain, M.; Liaquat, N.; Noorani, K.; Bhutta, S.Z; Jabeen, T.

    2004-01-01

    Objective: To determine the frequency, causes, clinical presentations, management and maternal mortality associated with acute puerperal inversion of the uterus. Materials and Methods: All the patients who developed acute puerperal inversion of the uterus either in or outside the JPMC were included in the study. Patients of chronic uterine inversion were not included in the present study. Abdominal and vaginal examination was done to confirm and classify inversion into first, second or third degrees. Results: 57036 deliveries and 36 acute uterine inversions occurred during the study period, so the frequency of uterine inversion was 1 in 1584 deliveries. Mismanagement of third stage of labour was responsible for uterine inversion in 75% of patients. Majority of the patients presented with shock, either hypovolemic (69%) or neurogenic (13%) in origin. Manual replacement of the uterus under general anaesthesia with 2% halothane was successfully done in 35 patients (97.5%). Abdominal hysterectomy was done in only one patient. There were three maternal deaths due to inversion. Conclusion: Proper education and training regarding placental delivery, diagnosis and management of uterine inversion must be imparted to the maternity care providers especially to traditional birth attendants and family physicians to prevent this potentially life-threatening condition. (author)

  2. Imaging for Polyps and Leiomyomas in Women With Abnormal Uterine Bleeding: A Systematic Review.

    Science.gov (United States)

    Maheux-Lacroix, Sarah; Li, Fiona; Laberge, Philippe Y; Abbott, Jason

    2016-12-01

    To evaluate the accuracy of saline infusion sonohysterography in comparison with transvaginal ultrasonography for diagnosing polyps and submucosal leiomyomas in women with abnormal uterine bleeding. We searched the databases MEDLINE, EMBASE, CENTRAL, and ClinicalTrials.gov as well as citations and reference lists to the end of November 2015. Two authors screened 5,347 citations for eligibility. We included randomized controlled trials or prospective cohort studies published in English, assessing the accuracy of saline infusion sonohysterography and transvaginal ultrasonography for diagnosing polyps and submucosal leiomyomas in women with abnormal uterine bleeding. We considered studies using histopathologic specimens obtained at either hysteroscopy or hysterectomy as criterion standard. Twenty-five studies were eligible. Two authors extracted data and assessed the quality of included studies. Bivariate random-effects models were used to compare the different tests and evaluate sources of heterogeneity. Saline infusion sonohysterography was superior to transvaginal ultrasonography with pooled sensitivity and specificity of 0.92 and 0.89 compared with 0.64 and 0.90, respectively (Pabnormal uterine bleeding. Although less specific than hysteroscopy, saline infusion sonohysterography offers a similar detection rate and permits concomitant visualization of the ovaries and myometrium. Cost, convenience, and tolerability of different imaging techniques require further evaluation. PROSPERO International prospective register of systematic reviews, http://www.crd.york.ac.uk/PROSPERO, CRD42016034005.

  3. Endometriosis and uterine malformations: infertility may increase severity of endometriosis.

    Science.gov (United States)

    Boujenah, Jeremy; Salakos, Eleonora; Pinto, Mélodie; Shore, Joanna; Sifer, Christophe; Poncelet, Christophe; Bricou, Alexandre

    2017-06-01

    The aim of our study was to compare the stage and severity of endometriosis in fertile and infertile women with congenital uterine malformations. We performed an observational study from September 2007 to December 2015 in a tertiary care university hospital and assisted reproductive technology center. A total of 52 patients with surgically proven uterine malformations were included. We compared 41 infertile patients with uterine malformations with 11 fertile patients with uterine malformation. The main outcome was the stage, score and type of endometriosis in regard to infertility and class of uterine malformation. The rate of endometriosis did not differ between the two groups (43.9 vs. 36.4%). The mean revised American Fertility Society score was higher in infertile patients with uterine malformations (19.02 vs. 6, p endometriosis (43.9 vs. 37.5%). Endometrioma and deep infiltrating endometriosis were associated with uterine malformations in infertile women, respectively 14.6 and 0%. No difference in the characteristics of endometriosis was found regarding the class of malformation. The association of uterine malformations and infertility may increase the severity of endometriosis and raise the issue of their diagnosis and management. © 2016 Nordic Federation of Societies of Obstetrics and Gynecology.

  4. DNA level and stereologic estimates of nuclear volume in squamous cell carcinomas of the uterine cervix. A comparative study with analysis of prognostic impact

    DEFF Research Database (Denmark)

    Sørensen, Flemming Brandt; Bichel, P; Jakobsen, A

    1992-01-01

    Grading of malignancy in squamous cell carcinomas of the uterine cervix is based on qualitative, morphologic examination and suffers from poor reproducibility. Using modern stereology, unbiased estimates of the three-dimensional, volume-weighted mean nuclear volume (nuclear vv), were obtained...... in pretreatment biopsies from 51 patients treated for cervical cancer in clinical Stages I through III (mean age of 56 years, follow-up period greater than 5 years). In addition, conventional, two-dimensional morphometric estimates of nuclear and mitotic features were obtained. DNA indices (DI) were estimated...... of nuclear vv were only of marginal prognostic significance (2P = 0.07). However, Cox multivariate regression analysis showed independent prognostic value of patient age and nuclear vv along with clinical stage and DI. All other investigated variables were rejected from the model. A prognostic index...

  5. Endovascular uterine artery interventions

    Directory of Open Access Journals (Sweden)

    Chandan J Das

    2017-01-01

    Full Text Available Percutaneous vascular embolization plays an important role in the management of various gynecologic and obstetric abnormalities. Transcatheter embolization is a minimally invasive alternative procedure to surgery with reduced morbidity and mortality, and preserves the patient's future fertility potential. The clinical indications for transcatheter embolization are much broader and include many benign gynecologic conditions, such as fibroid, adenomyosis, and arteriovenous malformations (AVMs, as well as intractable bleeding due to inoperable advanced-stage malignancies. The most well-known and well-studied indication is uterine fibroid embolization. Uterine artery embolization (UAE may be performed to prevent or treat bleeding associated with various obstetric conditions, including postpartum hemorrhage (PPH, placental implantation abnormality, and ectopic pregnancy. Embolization of the uterine artery or the internal iliac artery also may be performed to control pelvic bleeding due to coagulopathy or iatrogenic injury. This article discusses these gynecologic and obstetric indications for transcatheter embolization and reviews procedural techniques and outcomes.

  6. Uterine Vascular Lesions

    Science.gov (United States)

    Vijayakumar, Abhishek; Srinivas, Amruthashree; Chandrashekar, Babitha Moogali; Vijayakumar, Avinash

    2013-01-01

    Vascular lesions of the uterus are rare; most reported in the literature are arteriovenous malformations (AVMs). Uterine AVMs can be congenital or acquired. In recent years, there has been an increasing number of reports of acquired vascular lesions of the uterus following pregnancy, abortion, cesarean delivery, and curettage. It can be seen from these reports that there is confusion concerning the terminology of uterine vascular lesions. There is also a lack of diagnostic criteria and management guidelines, which has led to an increased number of unnecessary invasive procedures (eg, angiography, uterine artery embolization, hysterectomy for abnormal vaginal bleeding). This article familiarizes readers with various vascular lesions of the uterus and their management. PMID:24340126

  7. Therapeutic efficacy of uterine arterial embolization for intractable uterine hemorrhage

    International Nuclear Information System (INIS)

    Liu Lang; Lu Lianwei; Ke Mengjia; Zhao Ru'en; Zeng Shaolan

    2010-01-01

    Objective: To evaluate the therapeutic efficacy of uterine arterial embolization (UAE) for intractable uterine hemorrhage. Methods: 16 patients with intractable uterine hemorrhage underwent bilateral UAE after failed conventional conservative treatment. Results: Uterine hemorrhage ceased within 12 hours in 15 patients (93.8%) after bilateral super-selective UAE. Internal iliac artery embolization was performed on one patient (6.2%) and hysterectomy was eventually carried out because of recurrent hemorrhage. Conclusion: UAE is a rapid and effective treatment method obviating hysterectomy for intractable uterine hemorrhage. (authors)

  8. Acute migraine therapy: recent evidence from randomized comparative trials

    DEFF Research Database (Denmark)

    Mett, A.; Tfelt-Hansen, P.

    2008-01-01

    (1) A wide array of data regarding acute migraine treatment are available, but few trials strictly adhere to International Headache Society guidelines for patient inclusion criteria. (2) Triptans appear to have similar efficacy profiles, but among newer triptans, almotriptan offers improved...

  9. Uterine mesenchymal tumors

    Directory of Open Access Journals (Sweden)

    Nikhil A Sangle

    2011-01-01

    Full Text Available Uterine mesenchymal tumors are a heterogeneous group of neoplasms that can frequently be diagnostically challenging. Differentiation between the benign and malignant counterparts of mesenchymal tumors is significant due to differences in clinical outcome, and the role of the surgical pathologist in making this distinction (especially in the difficult cases cannot be underestimated. Although immunohistochemical stains are supportive toward establishing a final diagnosis, the morphologic features trump all the other ancillary techniques for this group of neoplasms. This review therefore emphasizes the key morphologic features required to diagnose and distinguish uterine mesenchymal tumors from their mimics, with a brief description of the relevant immunohistochemical features.

  10. Uterin Lipoleiomyoma: MR Findings

    International Nuclear Information System (INIS)

    Batur, Abdussamet; Alpaslan, Muhammed; Dundar, Ilyas; Ozgokce, Mesut; Yavuz, Alpaslan

    2015-01-01

    Uterine lipoleiomyoma is a rare and specific type of leiomyoma. A 60-year-old postmenopausal woman presented with abdominal pain. Her pelvic ultrasound demonstrated a normal- sized uterus with a well- circumscribed, heterogeneous mass located in the anterior corpus. A pelvic MRI revealed a mass including hyperintense areas on T1-weighted images and hypointense on fat-suppressed T1-weighted images, compatible with lipoleiomyoma. Uterine lipoleiomyomas are often misdiagnosed pre-operatively and it is important to distinguish leiomyomas from other tumors for prevention from supererogatory surgery. Imaging plays an important role for the exact differentiation

  11. The generalizability of NCI-sponsored clinical trials accrual among women with gynecologic malignancies.

    Science.gov (United States)

    Mishkin, Grace; Minasian, Lori M; Kohn, Elise C; Noone, Anne-Michelle; Temkin, Sarah M

    2016-12-01

    Enrollment of a representative population to cancer clinical trials ensures scientific reliability and generalizability of results. This study evaluated the similarity of patients enrolled in NCI-supported group gynecologic cancer trials to the incident US population. Accrual to NCI-sponsored ovarian, uterine, and cervical cancer treatment trials between 2003 and 2012 were examined. Race, ethnicity, age, and insurance status were compared to the analogous US patient population estimated using adjusted SEER incidence data. There were 18,913 accruals to 156 NCI-sponsored gynecologic cancer treatment trials, ovarian (56%), uterine (32%), and cervical cancers (12%). Ovarian cancer trials included the least racial, ethnic and age diversity. Black women were notably underrepresented in ovarian trials (4% versus 11%). Hispanic patients were underrepresented in ovarian and uterine trials (4% and 5% versus 18% and 19%, respectively), but not in cervical cancer trials (14 versus 11%). Elderly patients were underrepresented in each disease area, with the greatest underrepresentation seen in ovarian cancer patients over the age of 75 (7% versus 29%). Privately insured women were overrepresented among accrued ovarian cancer patients (87% versus 76%), and the uninsured were overrepresented among women with uterine or cervical cancers. These patterns did not change over time. Several notable differences were observed between the patients accrued to NCI funded trials and the incident population. Improving representation of racial and ethnic minorities and elderly patients on cancer clinical trials continues to be a challenge and priority. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. The utility of serum CA-125 in predicting extra-uterine disease in apparent early-stage endometrial cancer.

    Science.gov (United States)

    Nicklin, James; Janda, Monika; Gebski, Val; Jobling, Thomas; Land, Russell; Manolitsas, Tom; McCartney, Anthony; Nascimento, Marcelo; Perrin, Lewis; Baker, Jannah F; Obermair, Andreas

    2012-08-15

    Surgical staging in early-stage uterine cancer is controversial. Preoperative serum CA-125 may be of clinical value in predicting the presence of extra-uterine disease in patients with apparent early-stage endometrial cancer. Between October 6, 2005, and June 17, 2010, 760 patients were enrolled in an international, multicentre, prospective randomized trial (LACE) comparing laparotomy with laparoscopy in the management of endometrial cancer apparently confined to the uterus. Of these, 657 patients with endometrial adenocarcinoma had a preoperative serum CA-125 value recorded. Multiple cross-validation analysis was undertaken to correlate preoperative serum CA-125 with stage of disease (Stage I vs. Stage II+) after surgery. Patients' median preoperative serum CA-125 was 14 U/ml. A cutoff point of 30 U/ml was associated with the smallest misclassification error, and using this cutoff, 98 patients (14.9%) had elevated CA-125 levels. Of those, 36 (36.7%) had evidence of extra-uterine disease. Of the 116 patients (17.7%) with evidence of extra-uterine disease, 31.0% had an elevated CA-125 level. On univariate and multivariable logistic regression analysis, only preoperative CA-125 level, but no other preoperative clinical characteristics were found to be associated with extra-uterine spread of disease. Utilizing a cutoff point of 30 U/ml achieved a sensitivity, specificity, positive predictive value and negative predictive value of 31.0, 88.5, 36.7 and 85.7%, respectively. Elevated CA-125 above 30 U/ml in patients with apparent early-stage disease is a risk factor for the presence of extra-uterine disease and may assist clinicians in the management of patients with clinical Stage I endometrial cancer. Copyright © 2011 UICC.

  13. The mycotic ulcer treatment trial: a randomized trial comparing natamycin vs voriconazole.

    Science.gov (United States)

    Prajna, N Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Prajna, Lalitha; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; Ray, Kathryn J; Zegans, Michael E; McLeod, Stephen D; Porco, Travis C; Acharya, Nisha R; Lietman, Thomas M

    2013-04-01

    To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycintreated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=0.18 logMAR; 95% CI, 0.30 to 0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=0.41 logMAR; 95% CI,0.61 to 0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=0.02 logMAR; 95% CI, 0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Voriconazole should not be used as monotherapy in filamentous keratitis. clinicaltrials.gov Identifier: NCT00996736

  14. Uterine fibroids: clinical manifestations and contemporary management.

    Science.gov (United States)

    Doherty, Leo; Mutlu, Levent; Sinclair, Donna; Taylor, Hugh

    2014-09-01

    Uterine fibroids (leiomyomata) are extremely common lesions that are associated with detrimental effects including infertility and abnormal uterine bleeding. Fibroids cause molecular changes at the level of endometrium. Abnormal regulation of growth factors and cytokines in fibroid cells may contribute to negative endometrial effects. Understanding of fibroid biology has greatly increased over the last decade. Although the current armamentarium of Food and Drug Administration-approved medical therapies is limited, there are medications approved for use in heavy menstrual bleeding that can be used for the medical management of fibroids. Emergence of the role of growth factors in pathophysiology of fibroids has led researchers to develop novel therapeutics. Despite advances in medical therapies, surgical management remains a mainstay of fibroid treatment. Destruction of fibroids by interventional radiological procedures provides other effective treatments. Further experimental studies and clinical trials are required to determine which therapies will provide the greatest benefits to patients with fibroids. © The Author(s) 2014.

  15. Sexuality and Body Image After Uterine Artery Embolization and Hysterectomy in the Treatment of Uterine Fibroids: A Randomized Comparison

    International Nuclear Information System (INIS)

    Hehenkamp, Wouter J. K.; Volkers, Nicole A.; Bartholomeus, Wouter; Blok, Sjoerd de; Birnie, Erwin; Reekers, Jim A.; Ankum, Willem M.

    2007-01-01

    In this paper the effect of uterine artery embolization (UAE) on sexual functioning and body image is investigated in a randomized comparison to hysterectomy for symptomatic uterine fibroids. The EMbolization versus hysterectoMY (EMMY) trial is a randomized controlled study, conducted at 28 Dutch hospitals. Patients were allocated hysterectomy (n = 89) or UAE (n 88). Two validated questionnaires (the Sexual Activity Questionnaire [SAQ] and the Body Image Scale [BIS]) were completed by all patients at baseline, 6 weeks, and 6, 12, 18, and 24 months after treatment. Repeated measurements on SAQ scores revealed no differences between the groups. There was a trend toward improved sexual function in both groups at 2 years, although this failed to reach statistical significance except for the dimensions discomfort and habit in the UAE arm. Overall quality of sexual life deteriorated in a minority of cases at all time points, with no significant differences between the groups (at 24 months: UAE, 29.3%, versus hysterectomy, 23.5%; p = 0.32). At 24 months the BIS score had improved in both groups compared to baseline, but the change was only significant in the UAE group (p = 0.009). In conclusion, at 24 months no differences in sexuality and body image were observed between the UAE and the hysterectomy group. On average, both after UAE and hysterectomy sexual functioning and body image scores improved, but significantly so only after UAE

  16. Comparing Transcervical Intrauterine Lidocaine Instillation with Rectal Diclofenac for Pain Relief During Outpatient Hysteroscopy: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Sussan S. Mohammadi

    2015-05-01

    Full Text Available Objectives: There are a number of potential advantages to performing hysteroscopy in an outpatient setting. However, the ideal approach, using local uterine anesthesia or rectal non-steroidal anti-inflammatory drugs, has not been determined. Our objective was to compare the efficacy of intrauterine lidocaine instillation with rectal diclofenac for pain relief during diagnostic hysteroscopy. Methods: We conducted a double-blind randomized controlled trial on 70 nulliparous women with primary infertility undergoing diagnostic hysteroscopy. Subjects were assigned into one of two groups to receive either 100mg of rectal diclofenac or 5mL of 2% intrauterine lidocaine. The intensity of pain was measured by a numeric rating scale 0–10. Pain scoring was performed during insertion of the hysteroscope, during visualization of the intrauterine cavity, and during extrusion of the hysteroscope. Results: There were no statistically significant differences between the groups with regard to the mean pain score during intrauterine visualization (p=0.500. The mean pain score was significantly lower during insertion and extrusion of the hysteroscope in the diclofenac group (p=0.001 and p=0.030, respectively. Nine patients in the lidocaine group and five patients in diclofenac group needed supplementary intravenous propofol injection for sedation (p=0.060. Conclusions: Rectal diclofenac appears to be more effective than intrauterine lidocaine in reducing pain during insertion and extrusion of hysteroscope, but there are no significant statistical and clinical differences between the two methods with regard to the mean pain score during intrauterine inspection.

  17. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery.

    Science.gov (United States)

    Tuuli, Methodius G; Liu, Jingxia; Stout, Molly J; Martin, Shannon; Cahill, Alison G; Odibo, Anthony O; Colditz, Graham A; Macones, George A

    2016-02-18

    Preoperative skin antisepsis has the potential to decrease the risk of surgical-site infection. However, evidence is limited to guide the choice of antiseptic agent at cesarean delivery, which is the most common major surgical procedure among women in the United States. In this single-center, randomized, controlled trial, we evaluated whether the use of chlorhexidine-alcohol for preoperative skin antisepsis was superior to the use of iodine-alcohol for the prevention of surgical-site infection after cesarean delivery. We randomly assigned patients undergoing cesarean delivery to skin preparation with either chlorhexidine-alcohol or iodine-alcohol. The primary outcome was superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of definitions from the Centers for Disease Control and Prevention. From September 2011 through June 2015, a total of 1147 patients were enrolled; 572 patients were assigned to chlorhexidine-alcohol and 575 to iodine-alcohol. In an intention-to-treat analysis, surgical-site infection was diagnosed in 23 patients (4.0%) in the chlorhexidine-alcohol group and in 42 (7.3%) in the iodine-alcohol group (relative risk, 0.55; 95% confidence interval, 0.34 to 0.90; P=0.02). The rate of superficial surgical-site infection was 3.0% in the chlorhexidine-alcohol group and 4.9% in the iodine-alcohol group (P=0.10); the rate of deep infection was 1.0% and 2.4%, respectively (P=0.07). The frequency of adverse skin reactions was similar in the two groups. The use of chlorhexidine-alcohol for preoperative skin antisepsis resulted in a significantly lower risk of surgical-site infection after cesarean delivery than did the use of iodine-alcohol. (Funded by the National Institutes of Health and Washington University School of Medicine in St. Louis; ClinicalTrials.gov number, NCT01472549.).

  18. ENDOVASCULAR HEMOSTASIS IN UTERINE BLEEDING IN PATIENTS WITH UTERINE LEIOMYOMA

    Directory of Open Access Journals (Sweden)

    M. M. Damirov

    2017-01-01

    Full Text Available We report results of treatment for 72 patients with uterine leiomyoma (LM of various sizes and location, who had arrived with excessive uterine bleeding. All patients underwent urgent or urgently-delayed endovascular hemostasis by performing uterine arteries embolization (UAE. We analyzed clinical features of the disease after UAE in various sizes of tumors and studied immediate and long-term results of UAE in patients with LM.

  19. Uterine Cancer: Cancer of the Uterus

    Science.gov (United States)

    ... Subscribe To receive Publications email updates Submit Uterine cancer Cancer of the uterus (uterine cancer) is cancer ... Institute . Expand all | Collapse all What is uterine cancer? Cancer is a disease in which certain body ...

  20. Uterine transplantation: a systematic review

    Directory of Open Access Journals (Sweden)

    Dani Ejzenberg

    Full Text Available Up to 15% of the reproductive population is infertile, and 3 to 5% of these cases are caused by uterine dysfunction. This abnormality generally leads women to consider surrogacy or adoption. Uterine transplantation, although still experimental, may be an option in these cases. This systematic review will outline the recommendations, surgical aspects, immunosuppressive drugs and reproductive aspects related to experimental uterine transplantation in women.

  1. Clinical trial to compare tinnitus masking and tinnitus retraining therapy.

    Science.gov (United States)

    Henry, J A; Schechter, M A; Zaugg, T L; Griest, S; Jastreboff, P J; Vernon, J A; Kaelin, C; Meikle, M B; Lyons, K S; Stewart, B J

    2006-12-01

    Both tinnitus masking (TM) and tinnitus retraining therapy (TRT) can be effective therapies for amelioration of tinnitus. TM may be more effective for patients in the short term, but with continued treatment TRT may produce the greatest effects. Although TM and TRT have been used for many years, research has not documented definitively the efficacy of these methods. The present study was a controlled clinical trial to prospectively evaluate the clinical efficacy of these two methods for US military veterans with severe tinnitus. Over 800 veterans were screened to ensure that enrolled patients had tinnitus of sufficient severity to justify 18 months of individualized treatment. Qualifying patients (n=123) were placed quasi-randomly (alternating placement) into treatment with either TM or TRT. Treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated primarily using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index). Findings are presented from the three written questionnaires with respect to three categories of patients: describing tinnitus as a 'moderate,' 'big,' and 'very big' problem at baseline. Based on effect sizes, both groups showed considerable improvement overall. In general, TM effects remained fairly constant over time while TRT effects improved incrementally. For the patients with a 'moderate' and 'big' problem, TM provided the greatest benefit at 3 and 6 months; benefit to these TRT patients was slightly greater at 12 months, and much greater at 18 months. For patients with a 'very big' problem, TM provided the greatest benefit at 3 months. For these latter patients, results were about the same between groups at 6 months, and improvement for TRT was much greater at 12 months, with further gains at 18 months.

  2. Vaginal or uterine bleeding - overview

    Science.gov (United States)

    ... and other menstrual conditions; Abnormal menstrual periods; Abnormal vaginal bleeding ... There are many causes of abnormal vaginal bleeding. HORMONES ... Doctors call the problem abnormal uterine bleeding (AUB) . AUB ...

  3. A randomised controlled trial comparing the effect of adjuvant ...

    African Journals Online (AJOL)

    Background: Intrathecal adjuvants are added to local anaesthetics to improve the quality of neuraxial blockade and prolong the duration of analgesia during spinal anaesthesia. Used intrathecally, fentanyl improves the quality of spinal blockade as compared to plain bupivacaine and confers a short duration of post ...

  4. Clinical trial comparing excision and primary closure with modified ...

    African Journals Online (AJOL)

    Walid Galal Elshazly

    2011-12-03

    Dec 3, 2011 ... sure, advancement flap (Karydakis procedure), local advance- ment flap (V-Y advancement flap), and rotational flap. (Limberg flap, modified Limberg flap, gluteus maximus myo- cutaneous flap).5,6. However, there have been few clinical studies to compare the rhomboid fasciocutaneous transposition flap ...

  5. Clinical trial comparing excision and primary closure with modified ...

    African Journals Online (AJOL)

    The aim of this study was to compare modified Limberg flap procedure with excision and primary closure in the treatment of uncomplicated pilonidal disease. Methods: This study was conducted on 120 patients with uncomplicated sacrococcygeal pilonidal disease that were randomly allocated into two groups: group I ...

  6. Pain Relief in Labor: A Randomized Controlled Trial Comparing ...

    African Journals Online (AJOL)

    Conclusions: This study showed that 600 mg intramuscular paracetamol provides similar and modest pain relief in labor when compared to 100 mg intramuscular tramadol. It also has fewer maternal adverse effects and favorable neonatal outcome such as tramadol. It is concluded that intramuscular paracetamol is simple, ...

  7. Clinical outcomes and health care utilization pre- and post-laparoscopic radiofrequency ablation of symptomatic fibroids and laparoscopic myomectomy: a randomized trial of uterine-sparing techniques (TRUST) in Canada.

    Science.gov (United States)

    Rattray, Darrien D; Weins, Laura; Regush, Lexy C; Bowen, James M; O'Reilly, Daria; Thiel, John A

    2018-01-01

    The objective of this study was to compare laparoscopic ultrasound-guided radiofrequency ablation of fibroids (Lap-RFA) and laparoscopic myomectomy in terms of 1) health care utilization and 2) serious complication rates. The secondary objectives were comparison of subject responses to validated symptom and quality-of-life questionnaires. We hypothesized that Lap-RFA health care utilization and clinical outcomes would not be worse than those of laparoscopic myomectomy in the aggregate. Post-market, randomized, prospective, multicenter, longitudinal, non-inferiority interventional comparative evaluation of health care utilization and clinical outcomes in premenopausal women with symptomatic uterine fibroids who desired uterine conservation was conducted. Both procedures were planned as outpatient day surgeries. Health care resource utilization was measured during the procedure day and at 1 week, 1 and 3 months post-surgery. Symptom severity and quality of life were based on patients' responses to the Uterine Fibroid Symptom Severity and Quality-of-Life Questionnaire, EuroQol-5D-visual analog scale general health status and menstrual impact questionnaires, and time from work. Forty-five participants provided written informed consent and were enrolled (Lap-RFA, n=23; myomectomy, n=22) in Canada. Hospitalization time (primary endpoint) was 6.7±3.0 hours for the Lap-RFA group and 9.9±10.7 hours for the myomectomy group (Wilcoxon, p =0.0004). Intraoperative blood loss was lesser for Lap-RFA subjects: 25.2±21.6 versus 82.4±62.5 mL ( p =0.0002). Lap-RFA procedures took lesser time than myomectomy procedures: 70.0 versus 86.5 minutes ( p =0.018), and Lap-RFA required -34.9% (130 fewer) units of surgical equipment. At 3 months, both cohorts reported the same significant symptom severity reduction (-44.8%; p <0.0001). Lap-RFA subjects also took lesser time from work: 11.1±7.6 versus 18.5±10.6 days ( p =0.0193). One myomectomy subject was hospitalized overnight after

  8. PRIVATE MANUFACTURERS’ THRESHOLDS TO INVEST IN COMPARATIVE EFFECTIVENESS TRIALS

    OpenAIRE

    Basu, Anirban; Meltzer, David

    2012-01-01

    The recent rush of enthusiasm for public investment in comparative effectiveness research (CER) in the United States has focused attention on these public investments. However, little attention has been given to how changing public investment in CER may affect private manufacturers’ incentives for CER, which has long been a major source of CER. In this work, based on a simple revenue maximizing economic framework, we generate predictions on thresholds to invest in CER for a private manufactur...

  9. The efficacy of maggot debridement therapy - a review of comparative clinical trials

    DEFF Research Database (Denmark)

    Zarchi, K.; Jemec, G.B.

    2012-01-01

    in a variety of ulcers. However, comparative clinical trials and in particular randomized controlled trials investigating the efficacy of MDT are sparse. A systematic search in the literature showed three randomized clinical trials and five non randomized studies evaluating the efficacy of sterile Lucilia......, including hydrocolloid, hydrogel and saline moistened gauze. However, the design of the studies was suboptimal, with important differences in the use of other therapies, such as compression, that may influence both debridement and healing between the compared groups, as well as inappropriately short follow...

  10. Exteriorization or in-situ repair, comparison of options for uterine repair at cesarean delivery

    International Nuclear Information System (INIS)

    Zafar, B.; Shehzad, F.; Safdar, C.A.

    2016-01-01

    Objective of study is to compare peri-operative complications between exteriorization and intraabdominal repair of uterus after cesarean delivery. Study Design: Randomized controlled trial. Place and Duration of Study: Obstetrics and Gynecology Department of Pakistan Ordinance Factory Hospital, Wah Cantt, from 1st April 2010 to 30th September 2010. Material and Methods: Patients planned for 1st cesarean section under spinal anesthesia were randomly allocated by lottery method to exteriorized (A) or in situ uterine repair (B) group. Patients with history of uterine surgeries and cesarean section were excluded from study. Variables analyzed were operation time, peri-operative hemoglobin (Hb) fall, nausea and vomiting during the cesarean delivery. Results: The study analyzed 170 patients and divided them in 2 groups, having no significant difference with respect to maternal demographics, procedure statistics and indication of cesarean section. Significant difference was observed in operation time being 32.78 min in exteriorized group and 36.38 min in situ uterine repair group (p-value 0.0001). Hb percent fall was 0.85 g/dl and 0.92 g/dl respectively in both groups (p-value 0.62) Nausea and vomiting was 23.5 percent in group A and 11.8 percent in group B (p-value 0.02, 0.04 respectively) Conclusion: Peri-operative complications like operative time and Hb fall are less in uterine repair after temporary exteriorization as compared to intra-abdominal repair of uterus after cesarean delivery. Nausea and vomiting were increased in exteriorized group but proper regional anesthetic technique and achieving adequate analgesia can reduce patient discomfort. (author)

  11. Super selective uterine arterio-embolization in treating uterine myoma

    International Nuclear Information System (INIS)

    Gu Yaqin; Wang Jiangu; Shang Jinyun; Zhang Jian; Zhang Rulan; Tan Yuedi; Zhao Zehua; Xu Chongsen

    2001-01-01

    Objective: To study the clinical efficacy of super selective uterine arterio-embolization in treating uterine myoma. Methods: From February to August 2000, 28 cases of uterine myomas were under-gone bilateral arterio-embolization of tumor feeding vessels. Results: The successful rate of embolization catheterization reached 100%. B-mode ultrasound examination revealed the following during 1-6 months after the procedure, with an average shrinkage of 25% in volume for all cases in the first month follow up, complete disappearance of tumor in 8 cases and with an average shrinkage of 68% volumetrically for the other 20 cases, together with conspicuous decrease in volume of menstruation. Conclusions: Interventional treatment for uterine myoma is definite effective especially in submucosal uterine myoma

  12. Endometrial ablation in the management of abnormal uterine bleeding.

    Science.gov (United States)

    Laberge, Philippe; Leyland, Nicholas; Murji, Ally; Fortin, Claude; Martyn, Paul; Vilos, George; Leyland, Nicholas; Wolfman, Wendy; Allaire, Catherine; Awadalla, Alaa; Dunn, Sheila; Heywood, Mark; Lemyre, Madeleine; Marcoux, Violaine; Potestio, Frank; Rittenberg, David; Singh, Sukhbir; Yeung, Grace

    2015-04-01

    Abnormal uterine bleeding (AUB) is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for the problem during their reproductive years. To provide current evidence-based guidelines on the techniques and technologies used in endometrial ablation (EA), a minimally invasive technique for the management of AUB of benign origin. Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of both location in Canada and type of practice, as well as subspecialty expertise and general background in gynaecology. The committee reviewed all available evidence in the English medical literature, including published guidelines, and evaluated surgical and patient outcomes for the various EA techniques. Recommendations were established by consensus. Published literature was retrieved through searches of MEDLINE and The Cochrane Library in 2013 and 2014 using appropriate controlled vocabulary and key words (endometrial ablation, hysteroscopy, menorrhagia, heavy menstrual bleeding, AUB, hysterectomy). RESULTS were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English from January 2000 to November 2014. Searches were updated on a regular basis and incorporated in the guideline to December 2014. Grey (unpublished) literature was identifies through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). This document reviews the evidence regarding the available techniques and technologies for EA

  13. Transvaginal color Doppler imaging of uterine contractions in early pregnancies: Significance of uterine contractions in early pregnancy failure

    International Nuclear Information System (INIS)

    Lee, Eun Ju; Han, Chang Jin; Suh, Jung Ho; Kwon, Hyuck Chan

    1999-01-01

    To assess uterine contractions in early pregnancies using transvaginal color Doppler sonography (TVCDS) and to determine the role of uterine contractions in the diagnosis of early pregnancy failure. 76 patients with abnormal pregnancy diagnosed by sonography or histopathology up to 10 weeks of gestation and 38 normal pregnant women as the control group were examines with TVCDS. The presence of uterine contractions was determined by complete or partial disappearance of the color flow signals of vessels within myometrium, and the direction, amplitude (grade 1-3), and interval of uterine contractions were also evaluated. Uterine contractions were identified in 42 (55.3%) of 76 patients with abnormal pregnancy, whereas they were detected only in 2 (5.3%) of 38 normal pregnant women who had initial grade 1 contraction but disappeared in the follow-up study. In 26 patients with blighted ovum or missed abortion, 15 patients (57.7%),showed uterine contraction of grade 1 in 3 cases, grade 2 in 8 cases, and grade 3 in 4 cases and interval from 45 seconds to 5 minutes. In 30 patients with inevitable or incomplete abortion, 23 patients (76.6%) showed uterine contraction of grade 1 in 2 cases, grade 2 in 9 cases, and grade 3 in 12 cases and interval from 1 to 5 minutes. 4 (20%) of 20 patients with threatened abortion had uterine contraction of grade 2 and interval from 2 to 4 minutes. The presence of uterine contractions was significantly different in abnormal pregnancies compared with that of normal and also among the tree different groups of abnormal pregnancies, but the amplitude did not differ.

  14. Transvaginal color Doppler imaging of uterine contractions in early pregnancies: Significance of uterine contractions in early pregnancy failure

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Eun Ju; Han, Chang Jin; Suh, Jung Ho; Kwon, Hyuck Chan [Aju University SChool of Medicine, Suwon (Korea, Republic of)

    1999-06-15

    To assess uterine contractions in early pregnancies using transvaginal color Doppler sonography (TVCDS) and to determine the role of uterine contractions in the diagnosis of early pregnancy failure. 76 patients with abnormal pregnancy diagnosed by sonography or histopathology up to 10 weeks of gestation and 38 normal pregnant women as the control group were examines with TVCDS. The presence of uterine contractions was determined by complete or partial disappearance of the color flow signals of vessels within myometrium, and the direction, amplitude (grade 1-3), and interval of uterine contractions were also evaluated. Uterine contractions were identified in 42 (55.3%) of 76 patients with abnormal pregnancy, whereas they were detected only in 2 (5.3%) of 38 normal pregnant women who had initial grade 1 contraction but disappeared in the follow-up study. In 26 patients with blighted ovum or missed abortion, 15 patients (57.7%),showed uterine contraction of grade 1 in 3 cases, grade 2 in 8 cases, and grade 3 in 4 cases and interval from 45 seconds to 5 minutes. In 30 patients with inevitable or incomplete abortion, 23 patients (76.6%) showed uterine contraction of grade 1 in 2 cases, grade 2 in 9 cases, and grade 3 in 12 cases and interval from 1 to 5 minutes. 4 (20%) of 20 patients with threatened abortion had uterine contraction of grade 2 and interval from 2 to 4 minutes. The presence of uterine contractions was significantly different in abnormal pregnancies compared with that of normal and also among the tree different groups of abnormal pregnancies, but the amplitude did not differ.

  15. Trial of Labor Compared With Cesarean Delivery in Superobese Women.

    Science.gov (United States)

    Grasch, Jennifer L; Thompson, Jennifer L; Newton, J Michael; Zhai, Amy W; Osmundson, Sarah S

    2017-11-01

    To examine whether labor compared with planned cesarean delivery is associated with increased maternal and neonatal morbidity. We conducted a retrospective cohort study of all women with body mass indexes (BMIs) at delivery of 50 or greater delivering a live fetus at 34 weeks of gestation of greater between January 1, 2008, and December 31, 2015. Pregnancies with multiple gestations and major fetal anomalies were excluded. The primary outcome was a composite of maternal and neonatal morbidity and was estimated to be 50% in superobese women based on institutional data. A sample size of 338 women determined the study period and was selected to show a 30% difference in the incidence of the primary outcome between the two groups. Multivariate logistic regression adjusted for potential confounders. There were 344 women with BMIs of 50 or greater who met eligibility criteria, of whom 201 (58%) labored and 143 (42%) underwent planned cesarean delivery. Women who labored were younger, more likely to be nulliparous, and less likely to have pre-existing diabetes. Among women who labored, 45% underwent a cesarean delivery, most commonly for labor arrest (61%) or nonreassuring fetal status (28%). Composite maternal and neonatal morbidity was reduced among women who labored even after adjusting for age, parity, pre-existing diabetes, and prior cesarean delivery (adjusted odds ratio 0.42, 95% CI 0.24-0.75). In the subgroup of women (n=234) who underwent a cesarean delivery, whether planned (n=143) or after labor (n=91), there were no differences in maternal and neonatal morbidity except that severe maternal morbidity was increased in women (n=12) who labored (8.8% compared with 2.1%, relative risk 4.2, 95% CI 1.14-15.4). Despite high rates of cesarean delivery in women with superobesity, labor is associated with lower composite maternal and neonatal morbidity. Severe maternal morbidity may be higher in women who require a cesarean delivery after labor.

  16. Role of MRI in detecting involvement of the uterine internal os in uterine cervical cancer: Systematic review of diagnostic test accuracy

    Energy Technology Data Exchange (ETDEWEB)

    Boer, Peter de, E-mail: p.deboer@amc.uva.nl [Department of Radiation Oncology, Academic Medical Centre (AMC), University of Amsterdam (UvA), Meibergdreef 9, 1105 AZ Amsterdam (Netherlands); Adam, Judit A. [Department of Radiology, AMC, UvA (Netherlands); Department of Nuclear Medicine, AMC, UvA (Netherlands); Buist, Marrije R. [Department of Gynaecology and Obstetrics, AMC, UvA (Netherlands); Vijver, Marc J. van de [Department of Pathology, AMC, UvA (Netherlands); Rasch, Coen R. [Department of Radiation Oncology, Academic Medical Centre (AMC), University of Amsterdam (UvA), Meibergdreef 9, 1105 AZ Amsterdam (Netherlands); Stoker, Jaap; Bipat, Shandra [Department of Radiology, AMC, UvA (Netherlands); Stalpers, Lukas J.A. [Department of Radiation Oncology, Academic Medical Centre (AMC), University of Amsterdam (UvA), Meibergdreef 9, 1105 AZ Amsterdam (Netherlands)

    2013-09-15

    Purpose: In patients with uterine cervical cancer, pretreatment recognition of uterine extension is crucial in treatment decision-making for fertility-sparing surgery and for target delineation in radiotherapy. Although MRI is generally considered the most reliable method, its value for detecting involvement of the uterine internal os is unclear. Methods: Medline, Embase and Cochrane databases were systematically searched (January 1997–December 2012) for MRI studies that measured the accuracy of involvement of the uterine internal os compared to histopathology as reference standard in patients with uterine cervical cancer. Data were assessed using the QUADAS tool. Accuracy concerned either involvement (yes/no) of the uterine internal os, or measuring invasion distance toward the uterine corpus. Results: Two retrospective and two prospective studies described 366 patients diagnosed with uterine cervical cancer FIGO stage IIB or below, in whom 64 (17%) had uterine internal os involvement. For three studies the summary estimates of specificity, sensitivity, negative predictive value (NPV), positive predictive value (PPV), and accuracy were 91%, 97%, 99%, 79% and 95%, respectively; one study had an area under the curve (AUC) of 0.8. Conclusion: MRI has a high level of accuracy; however, data are limited and for validation a large prospective study is needed that compares actual measurements on MRI with histopathological examination.

  17. Lajjalu treatment of uterine prolapse

    Directory of Open Access Journals (Sweden)

    T M Shivanandaiah

    2010-01-01

    Full Text Available Mimosa pudica was found useful in cases of uterine prolapse with bleeding, consistent with my experience of working with the condition for more than 45 years, and treating hundreds of such cases of uterine prolapse. Hysterectomy has been avoided up to this date, and is not now expected to be recommended.

  18. The decision to conduct a head-to-head comparative trial: a game-theoretic analysis.

    Science.gov (United States)

    Mansley, Edward C; Elbasha, Elamin H; Teutsch, Steven M; Berger, Marc L

    2007-01-01

    Recent Medicare legislation calls on the Agency for Healthcare Research and Quality to conduct research related to the comparative effectiveness of health care items and services, including prescription drugs. This reinforces earlier calls for head-to-head comparative trials of clinically relevant treatment alternatives. Using a game-theoretic model, the authors explore the decision of pharmaceutical companies to conduct such trials. The model suggests that an important factor affecting this decision is the potential loss in market share and profits following a result of inferiority or comparability. This hidden cost is higher for the market leader than the market follower, making it less likely that the leader will choose to conduct a trial. The model also suggests that in a full-information environment, it will never be the case that both firms choose to conduct such a trial. Furthermore, if market shares and the probability of proving superiority are similar for both firms, it is quite possible that neither firm will choose to conduct a trial. Finally, the results indicate that incentives that offset the direct cost of a trial can prevent a no-trial equilibrium, even when both firms face the possibility of an inferior outcome.

  19. Randomized Controlled Trial Comparing Daycare and Overnight Stay Laparoscopic Cholecystectomy.

    Science.gov (United States)

    Salleh, A A M; Affirul, C A; Hairol, O; Zamri, Z; Azlanudin, A; Hilmi, M A; Razman, J

    2015-01-01

    This present study sought to review the feasibility and patients' satisfaction of laparoscopic cholecystectomy to be perform as daycare procedure. Sixty-two patients with symptomatic gallstones were recruited within a year. They were randomized into overnight stay and daycare groups. The outcomes and post-operative complications were analyzed. Fifty-eight patients were eligible for analysis and four patients were excluded because of conversion to open cholecystectomy. All patients in daycare group reported no fever but two patients in the overnight stay group complaint of post-operative fever (p=0.150). The mean pain score using Visual Analogue Score (VAS) in daycare group was 2.93 but in the overnight stay was recorded as 3.59 (p=0.98). Five patients had post-operative nausea and vomiting (PONV) in daycare group compared to 2 patients in the overnight stay group (p=0.227). Patient's satisfaction were higher in the daycare group (p=0.160). All patients in daycare group were back at work within a week but in overnight stay, 11 patients had to stay off work for more than one week (p=0.01). Daycare laparoscopic cholecystectomy is safe and feasible. The satisfaction of daycare surgery is higher than overnight stay group. Patients' selection is an important aspect of its success.

  20. Uterine fibroid: a review.

    Science.gov (United States)

    Akinyemi, B O; Adewoye, B R; Fakoya, T A

    2004-01-01

    Uterine fibroid is a benign tumour of uterine smooth muscle. The purpose of this review is to bring to light the current spectra of presentation and management status of this benign and very important cause of menstrual and fertility disturbance in African women and the Black race in general. This is especially so with the trivialization of its aetological factors and treatment by claims from alternative medical practitioners. This review, therefore sought to document what is currently known about the condition and what could possibly be done to achieve better results in its management. Literature on the subject above was reviewed using manual library search, electronic books such as CD-ROMS and journals articles published by various local and international authors on the subject; it also included internet search on relevant aspects of the topic. Fibroid is the commonest benign tumour of the female genital tract, it contributes about 70 to 80% of new growths in the female genital tracts, it is a cause of significant morbidity in women of reproductive age group and when complicated could be a significant cause of mortality. Spectrum of presentation mainly involves disturbance of menstruation, reduction in fertility, pressure and obstructive symptoms and rarely malignant presentations. When recognized early effective conservative and definitive therapies are available to offer relief for women and to make their menstrual and reproductive life more meaningful. From the literature reviewed, it was obvious that the subject of uterine fibroid is still not fully exhausted and there were a lot of research questions waiting to be answered on the aetiopathogenesis of the disease. There is also the need to fashion out better treatment alternatives that will reduce morbidity in the process of managing the patient as well as those that will further enhance reproductive potentials after treatment.

  1. Mathematical modeling of electrical activity of uterine muscle cells.

    Science.gov (United States)

    Rihana, Sandy; Terrien, Jeremy; Germain, Guy; Marque, Catherine

    2009-06-01

    The uterine electrical activity is an efficient parameter to study the uterine contractility. In order to understand the ionic mechanisms responsible for its generation, we aimed at building a mathematical model of the uterine cell electrical activity based upon the physiological mechanisms. First, based on the voltage clamp experiments found in the literature, we focus on the principal ionic channels and their cognate currents involved in the generation of this electrical activity. Second, we provide the methodology of formulations of uterine ionic currents derived from a wide range of electrophysiological data. The model is validated step by step by comparing simulated voltage-clamp results with the experimental ones. The model reproduces successfully the generation of single spikes or trains of action potentials that fit with the experimental data. It allows analyzing ionic channels implications. Likewise, the calcium-dependent conductance influences significantly the cellular oscillatory behavior.

  2. Phase I clinical trial of parenteral hydroxyurea in combination with pelvic and para-aortic external radiation and brachytherapy for patients with advanced squamous cell cancer of the uterine cervix

    International Nuclear Information System (INIS)

    Beitler, Jonathan J.; Anderson, Patrick; Haynes, Hilda; Sood, Brij; Fields, Abbi; Goldberg, Gary; Vikram, Bhadrasain; Runowicz, Carolyn D.; Wadler, Scott

    2002-01-01

    Purpose: Oral hydroxyurea (HU) is a potent radiation sensitizer, but in vitro studies have suggested that prolonged exposure to HU by way of continuous parenteral infusion would enhance clinical efficacy. The objective of this study was to determine the maximal tolerated dose and identify the toxicities of continuous infusion HU in combination with pelvic and para-aortic external beam radiotherapy (RT) and intrauterine brachytherapy in patients with locally advanced carcinoma of the uterine cervix. Methods: This Phase I study of concomitant RT was designed with an escalating dose schedule of HU administered by continuous infusion. HU was administered parenterally as a continuous infusion, 5 d/wk, during the first 21 days of external radiation, during the final 5 days of external beam RT, followed by another 5-day infusion schedule bracketing the single fraction of brachytherapy. The maximal tolerated dose was defined as the highest dose level at which 3 of 3 or 5 of 6 patients could be treated without dose-limiting toxicity. Results: At dose level 1 (0.25 mg/m 2 /min), 0 of 4 patients experienced Grade 4 toxicities and 2 patients experienced Grade 3 hematologic toxicities that were not considered dose-limiting. One of the first 4 patients at level 2 (0.375 mg/m 2 /min) had Grade 3 diarrhea, but the 3 subsequent patients tolerated the dose. At level 3 (0.5 mg/m 2 /min), 4 of 5 patients failed to complete therapy without a >7-day interruption in HU. Conclusions: The maximal tolerated dose of parenteral HU was 0.375 mg/m 2 /min when administered with concomitant RT. The most common toxicities were hematologic. A new trial, incorporating concurrent cisplatin, HU, and RT is planned

  3. Utility of 18F-FDG PET/CT in patients with advanced squamous cell carcinoma of the uterine cervix receiving concurrent chemoradiotherapy: a parallel study of a prospective randomized trial

    International Nuclear Information System (INIS)

    Liu, Feng-Yuan; Yen, Tzu-Chen; Lai, Chyong-Huey; Chao, Angel; Chou, Hung-Hsueh; Yang, Lan-Yan; Wang, Chun-Chieh; Hong, Ji-Hong; Lin, Gigin; Chang, Chee-Jen; Chang, Wei-Yang; Huang, Shu-Hua; Huang, Yu-Erh; Peng, Nan-Jing; Chang, Yu-Chen

    2016-01-01

    The aim of this prospective study was to assess the usefulness of 18 F-FDG PET/CT performed before and during treatment for predicting treatment failure in patients with advanced squamous cell carcinoma of the uterine cervix treated with concurrent chemoradiotherapy (CCRT). Patients with cervical squamous cell carcinoma, International Federation of Gynecology and Obstetrics stage III/IVA or positive pelvic or paraaortic lymph node (LN) metastasis without other distant metastasis on PET/CT entering a randomized trial of CCRT (AGOG 09-001) were eligible. PET/CT scans were performed at baseline, during week 3 of CCRT and 2 - 3 months after CCRT. PET/CT parameters were correlated with sites of failure and overall survival (OS). The resulting predictors developed from the study cohort were validated on two independent datasets using area under the curve values, sensitivities and specificities. With a median follow-up of 54 months for survivors, 20 (36 %) of the 55 eligible patients were proven to have treatment failure. Sites of failure were local in five, regional in 11, and distant in 11. Four predictors for local failure, three for regional failure, and four for distant failures were identified. After validation with two independent cohorts of 31 and 105 patients, we consider the following as clinically useful predictors: pretreatment metabolic tumour volume (MTV) and during-treatment cervical tumour MTV for local failure; during-treatment SUVnode (maximum standardized uptake value of LNs) for regional and distant failure, and during-treatment MTV for distant failure. During-treatment SUVnode (P =.001) and cervical tumour MTVratio (P =.004) were independent significant predictors of OS by stepwise Cox regression. PET/CT imaging before and during treatment is useful for predicting failure sites and OS, making tailored therapeutic modifications feasible with potential outcome improvement during primary therapy. (orig.)

  4. A randomized, multi-center, clinical trial to assess the efficacy and safety of alginate carboxymethylcellulose hyaluronic acid compared to carboxymethylcellulose hyaluronic acid to prevent postoperative intrauterine adhesion.

    Science.gov (United States)

    Kim, Tak; Ahn, Ki Hoon; Choi, Doo Seok; Hwang, Kyung Joo; Lee, Byoung Ick; Jung, Min Hyung; Kim, Jae Weon; Kim, Jong Hyuk; Cha, Sun Hee; Lee, Ki Hwan; Lee, Kyu Sup; Oh, Sung Tack; Cho, Chi Heum; Rhee, Jeong Ho

    2012-01-01

    To estimate the efficacy of alginate carboxymethylcellulose hyaluronic acid (ACH) gel to prevent intrauterine adhesions after hysteroscopic surgery in comparison with carboxymethylcellulose hyaluronic acid (CH) gel, which is known as an effective adhesion inhibitor. Randomized, multicenter, single-blind, clinical trial (Canadian Task Force classification I). Tertiary university hospital. One hundred eighty-seven patients with a surgically treatable intrauterine lesion (myomas, polyps, septa, intrauterine adhesion, dysfunctional uterine bleeding). Patients were randomized to 2 groups: hysteroscopic surgery plus intrauterine application of ACH or CH. The rate of adhesion formation and the adhesion severity score with type and extent were calculated 4 weeks after surgery. The ACH group had results that were comparable to the CH group in terms of the development of intrauterine adhesions at 4 weeks follow-up. The adhesion severities were not different between the 2 groups. In a subgroup without baseline intrauterine adhesion, the ACH group showed a lower intrauterine adhesion rate than the CH group (p = .016). ACH had a comparable efficacy to CH in terms of the adhesion rate and severity. In the case of no baseline intrauterine adhesion, intrauterine application of ACH after hysteroscopic surgery had a lower rate of intrauterine adhesion than application of CH. Copyright © 2012 AAGL. Published by Elsevier Inc. All rights reserved.

  5. Optimizing research in symptomatic uterine fibroids with development of a computable phenotype for use with electronic health records.

    Science.gov (United States)

    Hoffman, Sarah R; Vines, Anissa I; Halladay, Jacqueline R; Pfaff, Emily; Schiff, Lauren; Westreich, Daniel; Sundaresan, Aditi; Johnson, La-Shell; Nicholson, Wanda K

    2018-06-01

    Women with symptomatic uterine fibroids can report a myriad of symptoms, including pain, bleeding, infertility, and psychosocial sequelae. Optimizing fibroid research requires the ability to enroll populations of women with image-confirmed symptomatic uterine fibroids. Our objective was to develop an electronic health record-based algorithm to identify women with symptomatic uterine fibroids for a comparative effectiveness study of medical or surgical treatments on quality-of-life measures. Using an iterative process and text-mining techniques, an effective computable phenotype algorithm, composed of demographics, and clinical and laboratory characteristics, was developed with reasonable performance. Such algorithms provide a feasible, efficient way to identify populations of women with symptomatic uterine fibroids for the conduct of large traditional or pragmatic trials and observational comparative effectiveness studies. Symptomatic uterine fibroids, due to menorrhagia, pelvic pain, bulk symptoms, or infertility, are a source of substantial morbidity for reproductive-age women. Comparing Treatment Options for Uterine Fibroids is a multisite registry study to compare the effectiveness of hormonal or surgical fibroid treatments on women's perceptions of their quality of life. Electronic health record-based algorithms are able to identify large numbers of women with fibroids, but additional work is needed to develop electronic health record algorithms that can identify women with symptomatic fibroids to optimize fibroid research. We sought to develop an efficient electronic health record-based algorithm that can identify women with symptomatic uterine fibroids in a large health care system for recruitment into large-scale observational and interventional research in fibroid management. We developed and assessed the accuracy of 3 algorithms to identify patients with symptomatic fibroids using an iterative approach. The data source was the Carolina Data Warehouse for

  6. Uterine culture in mares.

    Science.gov (United States)

    Brook, D

    1984-05-01

    A guarded, sterile swab is used to obtain samples for uterine culture. With the mare in stocks, the tail bandage and the perineum washed, the culture rod is introduced into the vagina with a gloved hand. After the rod is guided through the cervix, the guard cap is dislodged and the swab is rubbed along the endometrium, after which the rod is extracted. Samples for uterine culture should only be obtained during full estrus. Swabs should be directly plated onto agar within 2 hours of collection. Blood agar is appropriate for initial screening, but use of specialized types of agar expedites identification of microbes. Plates are incubated at 37 C and inspected for growth every 12 hours. The type and number of bacterial colonies should be coupled with the history and clinical signs in deciding on the necessity and type of treatment. Pure, heavy bacterial growth is usually accompanied by clinical signs of infection. Interpretation of the significance of moderate bacterial growth may be aided by cytologic examination of endometrial smears, made by rolling the swab onto a glass slide and staining with Diff - Quik . Large numbers of neutrophils indicate the need for antibiotic therapy. Mixed bacterial growth and variable numbers of neutrophils usually indicate faulty sampling technic. Microaerophilic or anaerobic cultures may aid diagnosis in cases of equivocal aerobic culture results.

  7. Dysfunctional Uterine Bleeding (DUB) (For Teens)

    Science.gov (United States)

    ... Staying Safe Videos for Educators Search English Español Abnormal Uterine Bleeding (AUB) KidsHealth / For Teens / Abnormal Uterine Bleeding (AUB) ... Print en español Sangrado uterino anormal What Is Abnormal Uterine Bleeding? Abnormal uterine bleeding (AUB) is the name doctors ...

  8. Uterine transplantation: Review in human research.

    Science.gov (United States)

    Favre-Inhofer, A; Rafii, A; Carbonnel, M; Revaux, A; Ayoubi, J M

    2018-06-01

    Uterine transplantation is the solution to treat absolute uterine fertility. In this review, we present the historical, medical, technical, psychological and ethical perspectives in human uterine transplantation research. We reviewed the PubMed database following PRISMA guidelines and added data presented by several research teams during the first international congress on uterine transplantation. Copyright © 2018. Published by Elsevier Masson SAS.

  9. Trans-abdominal ultrasound evaluation of high-intensity focused ultrasound treatment of uterine leiomyoma

    International Nuclear Information System (INIS)

    Miao Wei; Huang Jin; Wang Junhua; Wang Yuling

    2010-01-01

    Objective: To determine the value of dynamic trans-abdominal ultrasound after high-intensity focused ultrasound (HIFU) treatment of uterine leiomyomas. Methods: The trans-abdominal ultrasound images of 63 patients before and after HIFU treatment of uterine leiomyomas were compared. Results: The volume and blood flow of leiomyomas were reduced after the HIFU treatment. Conclusion: Trans-abdominal ultrasound is a valuable method for evaluating the results of HIFU treatment of uterine leiomyomas. (authors)

  10. The utility of diffusion-weighted MR imaging in differentiation of uterine adenomyosis and leiomyoma

    International Nuclear Information System (INIS)

    Yang Qiong; Zhang Lihua; Su Jing; Liu Jianyu

    2011-01-01

    Purpose: To investigate the value of diffusion-weighted MR imaging (DWI), especially apparent diffusion coefficient (ADC) in the differentiation of uterine adenomyosis and leiomyoma. Materials and methods: 17 patients with uterine leiomyoma and 22 patients with uterine adenomyosis underwent diffusion-weighted imaging (DWI) in addition to routine MR imaging. The ADC values, as well as ADC D-value (defined as the ADC value of high signal intensive foci minus the ADC value of lesion tissues the difference in value), were measured and compared to investigate whether they could help in the differentiation of uterine adenomyosis and leiomyoma. Histopathologic examination was conducted as the golden standard. Results: For high signal intensive foci within the lesions, uterine adenomyosis demonstrated significantly lower mean ADC value than uterine leiomyoma (1.582 vs. 2.122 x 10 -3 mm 2 /s, P = 0.001). For lesion tissues, uterine adenomyosis demonstrated significantly higher mean ADC value than uterine leiomyoma (1.214 vs. 0.967 x 10 -3 mm 2 /s, P = 0.001). However, there was overlap between uterine adenomyosis and leiomyoma in both measurements. Mean ADC D-value was significantly lower in uterine adenomyosis than in uterine leiomyoma (0.369 vs. 1.096 x 10 -3 mm 2 /s, P = 0.000). ADC D-value had no overlap between uterine adenomyosis and leiomyoma. Conclusion: DWI can be applied for the further differentiation of uterine adenomyosis and leiomyoma, in addition to routine MR imaging. ADC D-value may be a more useful tool than ADC value in the differentiation.

  11. The utility of diffusion-weighted MR imaging in differentiation of uterine adenomyosis and leiomyoma

    Energy Technology Data Exchange (ETDEWEB)

    Yang Qiong, E-mail: yangq1112@126.com [Department of Radiology, Peking University Third Hospital, Beijing 100191 (China); Zhang Lihua, E-mail: zhanglh04036@yahoo.com.cn [Department of Radiology, Peking University Third Hospital, Beijing 100191 (China); Su Jing, E-mail: bjmusujing@gmail.com [Department of Pathology, Peking University Health Science Center, Beijing 100191 (China); Liu Jianyu, E-mail: jyliu5791@sina.com [Department of Radiology, Peking University Third Hospital, Beijing 100191 (China)

    2011-08-15

    Purpose: To investigate the value of diffusion-weighted MR imaging (DWI), especially apparent diffusion coefficient (ADC) in the differentiation of uterine adenomyosis and leiomyoma. Materials and methods: 17 patients with uterine leiomyoma and 22 patients with uterine adenomyosis underwent diffusion-weighted imaging (DWI) in addition to routine MR imaging. The ADC values, as well as ADC D-value (defined as the ADC value of high signal intensive foci minus the ADC value of lesion tissues the difference in value), were measured and compared to investigate whether they could help in the differentiation of uterine adenomyosis and leiomyoma. Histopathologic examination was conducted as the golden standard. Results: For high signal intensive foci within the lesions, uterine adenomyosis demonstrated significantly lower mean ADC value than uterine leiomyoma (1.582 vs. 2.122 x 10{sup -3} mm{sup 2}/s, P = 0.001). For lesion tissues, uterine adenomyosis demonstrated significantly higher mean ADC value than uterine leiomyoma (1.214 vs. 0.967 x 10{sup -3} mm{sup 2}/s, P = 0.001). However, there was overlap between uterine adenomyosis and leiomyoma in both measurements. Mean ADC D-value was significantly lower in uterine adenomyosis than in uterine leiomyoma (0.369 vs. 1.096 x 10{sup -3} mm{sup 2}/s, P = 0.000). ADC D-value had no overlap between uterine adenomyosis and leiomyoma. Conclusion: DWI can be applied for the further differentiation of uterine adenomyosis and leiomyoma, in addition to routine MR imaging. ADC D-value may be a more useful tool than ADC value in the differentiation.

  12. A Comparative Effectiveness Education Trial for Lifestyle Health Behavior Change in African Americans

    Science.gov (United States)

    Halbert, Chanita Hughes; Bellamy, Scarlett; Briggs, Vanessa; Delmoor, Ernestine; Purnell, Joseph; Rogers, Rodney; Weathers, Benita; Johnson, Jerry C.

    2017-01-01

    Obesity and excess weight are significant clinical and public health issues that disproportionately affect African Americans because of physical inactivity and unhealthy eating. We compared the effects of alternate behavioral interventions on obesity-related health behaviors. We conducted a comparative effectiveness education trial in a…

  13. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction

    NARCIS (Netherlands)

    M.L. Simoons (Maarten); E.J. Topol (Eric); R.M. Califf (Robert); F.J.J. van de Werf (Frans); P.W. Armstrong (Paul); P.E. Aylward (Philip Edmund); G.I. Barbash; E.R. Bates (Eric); A. Betriu; J.H. Chesebro (James); J.J. Col (Jacques); D.P. de Bono (David); J.M. Gore (Joel); A.D. Guerci (Alan); J.R. Hampton (John)

    1993-01-01

    textabstractBACKGROUND: The relative efficacy of streptokinase and tissue plasminogen activator and the roles of intravenous as compared with subcutaneous heparin as adjunctive therapy in acute myocardial infarction are unresolved questions. The current trial was designed to compare new, aggressive

  14. Comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: a randomized trial

    Science.gov (United States)

    Background: Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. Objective: To compare Tai Chi with standard physical therapy f...

  15. Uterine arterial embolization for the treatment of adenomyosis: an analysis of therapeutic results in 80 cases

    International Nuclear Information System (INIS)

    Ai Zigang; Yang Yanfen; Guan Jie

    2010-01-01

    Objective: To discuss the therapeutic effect of uterine arterial embolization in treating adenomyosis. Methods: Uterine arterial embolization was performed in 80 patients with adenomyosis. The patients were followed up for 3, 6, 12 and 24 months after the operation. After the treatment the degree of dysmenorrhea, the menstrual flow and the uterine volume were observed and were compared with those before the treatment. Results: After uterine arterial embolization the clinical symptoms were relieved in all 80 patients. The menstrual flow was markedly decreased, the anemia was obviously improved and the uterine volume was significantly reduced, while the ovary functioning was not apparently affected. The symptom of dysmenorrhea completely disappeared one month after the therapy in 76 cases and four months after the therapy in the remaining 4 cases. Conclusion: Uterine arterial embolization is a mini-invasive and safe therapy with remarkable therapeutic results and few side-effects. Therefore, this treatment can significantly improve the patient's living quality. (authors)

  16. ERα inhibited myocardin-induced differentiation in uterine fibroids

    Energy Technology Data Exchange (ETDEWEB)

    Liao, Xing-Hua, E-mail: xinghualiao@hotmail.com [Institute of Biology and Medicine, Wuhan University of Science and Technology, Wuhan, 430065 (China); Key Laboratory of Industrial Fermentation Microbiology, Ministry of Education and Tianjin, College of Biotechnology, Tianjin University of Science and Technology, Tianjin 300457 (China); Li, Jun-Yan [Henan Vocational College of Applied Technology, Zhengzhou 450042 (China); Dong, Xiu-Mei [Institute of Biology and Medicine, Wuhan University of Science and Technology, Wuhan, 430065 (China); Yuncheng County People' s Hospital, Shandong 274700 (China); Wang, Xiuhong [Xianning Central Hospital, Department of Obstetrics and Gynecology, Xianning, Hubei 437100 (China); Xiang, Yuan; Li, Hui; Yu, Cheng-Xi; Li, Jia-Peng; Yuan, Bai-Yin [Institute of Biology and Medicine, Wuhan University of Science and Technology, Wuhan, 430065 (China); Zhou, Jun, E-mail: zhoujun@wust.edu.cn [Institute of Biology and Medicine, Wuhan University of Science and Technology, Wuhan, 430065 (China); School of Medicine, Wuhan University of Science and Technology, Wuhan 430065 (China); Zhang, Tong-Cun, E-mail: zhangtongcun@wust.edu.cn [Institute of Biology and Medicine, Wuhan University of Science and Technology, Wuhan, 430065 (China); Key Laboratory of Industrial Fermentation Microbiology, Ministry of Education and Tianjin, College of Biotechnology, Tianjin University of Science and Technology, Tianjin 300457 (China)

    2017-01-01

    Uterine fibroids, also known as uterine leiomyomas, are a benign tumor of the human uterus and the commonest estrogen-dependent benign tumor found in women. Myocardin is an important transcriptional regulator in smooth and cardiac muscle development. The role of myocardin and its relationship with ERα in uterine fibroids have barely been addressed. We noticed that the expression of myocardin was markedly reduced in human uterine fibroid tissue compared with corresponding normal or adjacent myometrium tissue. Here we reported that myocardin induced the transcription and expression of differentiation markers SM22α and alpha smooth muscle actin (α-SMA) in rat primary uterine smooth muscle cells (USMCs) and this effect was inhibited by ERα. Notably, we showed that, ERα induced expression of proliferation markers PCNA and ki-67 in rat primary USMCs. We also found ERα interacted with myocardin and formed complex to bind to CArG box and inhibit the SM22α promoter activity. Furthermore, ERα inhibited the transcription and expression of myocardin, and reduced the levels of transcription and expression of downstream target SM22α, a SMC differentiation marker. Our data thus provided important and novel insights into how ERα and myocardin interact to control the cell differentiation and proliferation of USMCs. Thus, it may provide potential therapeutic target for uterine fibroids.

  17. Uterine Artery Anatomy Relevant to Uterine Leiomyomata Embolization

    International Nuclear Information System (INIS)

    Gomez-Jorge, Jackeline; Keyoung, Andrew; Levy, Elliot B.; Spies, James B.

    2003-01-01

    To categorize the anatomic variants of uterine arteries, and determine the incidence of menopausal symptoms where the tubo-ovarian branches were seen prior to embolization. Between July 1997 and June 2000, 257 (n = 257) uterine fibroid embolizations were performed at our institution. Arteriograms were retrospectively evaluated. Uterine arteries were classified into groups: type I (the uterine artery as first branch of the inferior gluteal artery), type II (the uterine artery as second or third branch of the inferior gluteal artery), type III (the uterine artery, the inferior gluteal and the superior gluteal arteries arising as a trifurcation), type IV (the uterine artery as first branch of the hypogastric artery), inconclusive, or not studied. Tubo-ovarian branches were recorded if visualized prior to and/or after embolization. Menopausal symptoms were recorded (n = 175 at 3 months, n = 139 at 6 months, n = 98 at 1 year, n = 22 at 2 years) using written questionnaires. Five hundred and fourteen uterine arteries (n = 514) were evaluated. There were 38% classifiable types, 23% inconclusive, and 39% not studied. Classification was as follows: type I, 45%; type II, 6%; type III, 43%; type IV, 6%. Among 256 patients, tubo-ovarian arteries were seen in 36 prior to embolization, but not afterwards. In this group, 25 patients reported transient menopausal symptoms (hot flashes, amenorrhea). Five patients did not report any menopausal symptoms. Six patients did not answer the questionnaires. Type I is the most common type of anatomy, followed by type III. The tubo-ovarian arteries may be visualized prior to and/or after embolization. The embolization was monitored to avoid embolization of the tubo-ovarian branches. Menopausal symptoms were transient all patients when the tubo-ovarian branches were seen prior to embolization

  18. Complications and Reinterventions in Uterine Artery Embolization for Symptomatic Uterine Fibroids: A Literature Review and Meta Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Martin, Jason, E-mail: Jason.martin@medportal.ca; Bhanot, Kunal, E-mail: Kunal.Bhanot@medportal.ca [Michael G. DeGroote School of Medicine, McMaster University (Canada); Athreya, Sriharsha, E-mail: harshavbs@yahoo.com [St. Joseph' s Health Care Hamilton, McMaster University, Faculty of Health Sciences (Canada)

    2013-04-15

    To perform a literature review of the spectrum of complications associated with UAE relative to surgery and compare the risk of reintervention as well as minor, major, and overall complications. Literature review was conducted in PubMed, MEDLINE, Cochrane, and CINAHL databases, and meta-analysis was performed. In randomized clinical trials, common complications were discharge and fever (4.00 %), bilateral uterine artery embolization (UAE) failure (4.00 %), and postembolization syndrome (2.86 %). Two trials showed a significantly decreased risk in major complications with UAE, with odds ratios (ORs) of 0.07143 (0.009426-0.5413) and 0.5196 (0.279-0.9678). None of the trials showed a significant difference in OR for minor complications of UAE. None of the trials showed a significant difference in risk for overall complications of UAE. Three trials showed a significantly increased risk for reintervention with UAE with ORs of 10.45 (2.654-41.14), 2.679 (1.289-5.564), and 9.096 (1.269-65.18). In 76 nonrandomized studies, common complications were amenorrhea (4.26 %), pain (3.59 %), and discharge and fever (3.37 %). In 41 case studies, common complications were discharge and fever (n = 22 cases), repeat UAE (n = 6 cases), and fibroid expulsion (n = 5 cases). Overall, UAE has a significantly lower rate of major complications relative to surgery, but it comes at the cost of increased risk of reintervention in the future. Educating patients about the rate and types of complications of UAE versus surgery, as well as the potential for reintervention, should help the patient and clinician come to a reasoned decision.

  19. Complications and Reinterventions in Uterine Artery Embolization for Symptomatic Uterine Fibroids: A Literature Review and Meta Analysis

    International Nuclear Information System (INIS)

    Martin, Jason; Bhanot, Kunal; Athreya, Sriharsha

    2013-01-01

    To perform a literature review of the spectrum of complications associated with UAE relative to surgery and compare the risk of reintervention as well as minor, major, and overall complications. Literature review was conducted in PubMed, MEDLINE, Cochrane, and CINAHL databases, and meta-analysis was performed. In randomized clinical trials, common complications were discharge and fever (4.00 %), bilateral uterine artery embolization (UAE) failure (4.00 %), and postembolization syndrome (2.86 %). Two trials showed a significantly decreased risk in major complications with UAE, with odds ratios (ORs) of 0.07143 (0.009426–0.5413) and 0.5196 (0.279–0.9678). None of the trials showed a significant difference in OR for minor complications of UAE. None of the trials showed a significant difference in risk for overall complications of UAE. Three trials showed a significantly increased risk for reintervention with UAE with ORs of 10.45 (2.654–41.14), 2.679 (1.289–5.564), and 9.096 (1.269–65.18). In 76 nonrandomized studies, common complications were amenorrhea (4.26 %), pain (3.59 %), and discharge and fever (3.37 %). In 41 case studies, common complications were discharge and fever (n = 22 cases), repeat UAE (n = 6 cases), and fibroid expulsion (n = 5 cases). Overall, UAE has a significantly lower rate of major complications relative to surgery, but it comes at the cost of increased risk of reintervention in the future. Educating patients about the rate and types of complications of UAE versus surgery, as well as the potential for reintervention, should help the patient and clinician come to a reasoned decision.

  20. Uterine arterial embolization for uterine leiomyoma: efficacy and clinical outcome

    International Nuclear Information System (INIS)

    Park, Jeong Seon; Lee, Do Yon; Kim, Yong Tae; Park, Ki Hyun; Park, Yong Won; Cho, Jae Sung; Kim, Myung Jun; Won, Je Hwan; Kang, Byung Chul

    1999-01-01

    To determine the efficacy and clinical outcome of uterine arterial embolization as a new approach to the management of uterine leiomyomas. Uterine arterial embolization was performed in 21 patients aged 26-62(mean, 42) years. Twenty of these had menorrhagia, dysmenorrhea, and mass-related symptoms (low abdominal discomfort, backache, urinary frequency, etc.) and one was diagnosed incidentally. Bilateral uterine arteries were selected individually and polyvinyl alcohol and/or gelfoam was used as an embolic material. Nineteen patients were followed up after embolization. Seventeen (89.5 %)reported satisfactory improvement of symptoms and follow-up sonography three months later showed a 58.5 % reduction in mean myoma volume. In 17 patients (89.5 %), the menstrual cycle returned to normal. All patients experienced pain after the procedure and other complications were vaginal bleeding (26.3 %) and fever (23.8 %). Uterine arterial embolization represents a new approach to the management of uterine leiomyoma-related symptoms. Further investigations and long-term follow-up are, however, enquired

  1. Uterine arterial embolization for uterine leiomyoma: efficacy and clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jeong Seon; Lee, Do Yon; Kim, Yong Tae; Park, Ki Hyun; Park, Yong Won; Cho, Jae Sung; Kim, Myung Jun [Yonsei Univ. College of Medicine, Seoul (Korea, Republic of); Won, Je Hwan [Ajou Univ. College of Medicine, Suwon (Korea, Republic of); Kang, Byung Chul [Ewha Womans Univ. College of Medicine, Seoul (Korea, Republic of)

    1999-09-01

    To determine the efficacy and clinical outcome of uterine arterial embolization as a new approach to the management of uterine leiomyomas. Uterine arterial embolization was performed in 21 patients aged 26-62(mean, 42) years. Twenty of these had menorrhagia, dysmenorrhea, and mass-related symptoms (low abdominal discomfort, backache, urinary frequency, etc.) and one was diagnosed incidentally. Bilateral uterine arteries were selected individually and polyvinyl alcohol and/or gelfoam was used as an embolic material. Nineteen patients were followed up after embolization. Seventeen (89.5 %)reported satisfactory improvement of symptoms and follow-up sonography three months later showed a 58.5 % reduction in mean myoma volume. In 17 patients (89.5 %), the menstrual cycle returned to normal. All patients experienced pain after the procedure and other complications were vaginal bleeding (26.3 %) and fever (23.8 %). Uterine arterial embolization represents a new approach to the management of uterine leiomyoma-related symptoms. Further investigations and long-term follow-up are, however, enquired.

  2. Uterine Necrosis after Uterine Artery Embolization for Symptomatic Fibroids

    Directory of Open Access Journals (Sweden)

    Steve Kyende Mutiso

    2018-01-01

    Full Text Available Introduction. Uterine artery embolization (UAE is a minimally invasive intervention that is used in the treatment of fibroids. UAE can lead to complications including postembolization syndrome, postprocedure pain, infection, endometrial atrophy leading to secondary amenorrhea, and uterine necrosis. Uterine necrosis after UAE is very rare and hence poses a clinical dilemma for any clinician in its identification and management. We document a case of uterine necrosis after UAE and conduct a literature review on its causation, clinical features, and management principles. Case. A patient presented one month after UAE with abdominal pain and abdominal vaginal discharge. Her work-up revealed features of possible uterine necrosis with sepsis and she was scheduled for a laparotomy and a subtotal hysterectomy was performed. She was subsequently managed with broad spectrum antibiotic and recovered well. Conclusion. Uterine necrosis after UAE is a rare occurrence and we hope the documentation of this case will add to the body of knowledge around it. Theories that explain its occurrence include the use of small particles at embolization, the use of Contour-SE a spherical poly-vinyl alcohol, and lack of collateral supply to the uterus. Its symptoms may be nonspecific but unremitting abdominal pain is invariably present. Finally although conservative management may be successful at times, surgical management with hysterectomy will be required in some cases. The prognosis is good after diagnosis and surgical management.

  3. Medical Treatment for Uterine Myomas

    Directory of Open Access Journals (Sweden)

    Ming-Hui Cheng

    2008-03-01

    Full Text Available Uterine myomas are the most common benign tumors in the female reproductive tract. Most women with myomas are asymptomatic. Therefore, expectant observation and follow-up are often recommended for these myoma patients. However, myomas may cause menstrual symptoms, pelvic pain, pressure complaints, subfer-tility or pregnancy-related complications, with resultant requests for a definitive treatment. The management of myomas has become multidisciplinary in the past 20 years. Basically, the choice of treatment depends on the patient's age, the reason for treatment, the issue of fertility preservation, and the patient's preference. The treatment spectrum includes an expectant management, medical therapy, surgical intervention, uterine artery embolization or ablative techniques. Medical therapy is an option for women with symptomatic myomas who prefer non-surgical treatment, consider fertility preservation, or expect a less aggressive operation after shrinkage of the uterine volume. This review will summarize the recent well-documented drugs for the management of uterine myomas.

  4. Imaging of uterine cervix carcinoma

    International Nuclear Information System (INIS)

    Viala, J.

    2000-01-01

    Imaging of uterine cervix carcinoma has evolved during the last decade. Recent developments in magnetic resonance imaging have expanded the role of MRI in evaluating the pathology of uterine cervix carcinoma. MRI is now the modality of choice for tumor staging, evaluating tumor response to treatment, diagnosing recurrences and for evaluating pregnant patients. MRI images will soon be used to calculate dosimetry for brachytherapy with matching and fusion software. (author)

  5. Primary uterine inertia in four labrador bitches.

    Science.gov (United States)

    Davidson, Autumn P

    2011-01-01

    Uterine inertia is a common cause of dystocia in the bitch and is designated as primary (i.e., uterine contractions fail to ever be initiated) or secondary (i.e., uterine contractions cease after a period of time but before labor is completed). The etiology of primary uterine inertia is not well understood. The accurate diagnosis of primary uterine inertia requires the use of tocodynamometry (uterine monitoring). Primary uterine inertia has been postulated to result from a failure of luteolysis resulting in persistently elevated progesterone concentrations. In this study, primary uterine inertia was diagnosed in a series of four bitches in which luteolysis was documented suggesting some other etiopathogenesis for primary uterine inertia.

  6. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

    Science.gov (United States)

    Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

    2013-02-08

    Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting

  7. Cell-cycle and suppressor proteins expression in uterine cervix in HIV/HPV co-infection: comparative study by tissue micro-array (TMA)

    International Nuclear Information System (INIS)

    Nicol, Alcina F; Pirmez, Claude; Pires, Andréa Rodrigues Cordovil; Souza, Simone R de; Nuovo, Gerard J; Grinsztejn, Beatriz; Tristão, Aparecida; Russomano, Fabio B; Velasque, Luciane; Silva, José R Lapa e

    2008-01-01

    The oncoproteins of human papillomavirus (HPVs) directly effect cell-cycle control. We hypothesize that regulatory and cell cycle protein expression might be additionally modified in the cervix of HIV/HPV co-infected women. We analyzed the expression of Rb, p27, VEGF and Elf-1 transcriptor factor by immunohistochemistry in 163 paraffin-embeded cervical samples using Tissue Micro-Array (TMA) and correlated this to HIV-1 and HPV infection. HIV/HPV co-infection was associated with a significant increase in expression (p < 0.001) of VEGF and p27 in both low and high grade CIN when compared to the cervices of women infected by HPV alone. Decreased Rb expression was evident with increased CIN grade in the cervices of women infected with HPV alone (p = 0.003 average of cells/mm 2 in CIN I: 17.9, CIN II/III: 4.8, and tumor 3.9). Rb expression increased 3-fold for both low and high grade CIN with HPV/HIV-1 co-infection compared to HPV infection alone but did not reach statistical significance. There was a significant increase in Elf-1 expression in HPV+/HIV- women with CIN II/III and tumor (average of cells/mm 2 in CIN I: 63.8; CIN II/III: 115.7 and tumor: 112.0, p = 0.005), in comparison to controls. Co-infection of HPV and HIV leads to significant increase in the VEGF and p27 expression when compared to HPV+/HIV-negative infection that could facilitate viral persistence and invasive tumor development

  8. Cell-cycle and suppressor proteins expression in uterine cervix in HIV/HPV co-infection: comparative study by tissue micro-array (TMA).

    Science.gov (United States)

    Nicol, Alcina F; Pires, Andréa Rodrigues Cordovil; de Souza, Simone R; Nuovo, Gerard J; Grinsztejn, Beatriz; Tristão, Aparecida; Russomano, Fabio B; Velasque, Luciane; Lapa e Silva, José R; Pirmez, Claude

    2008-10-07

    The oncoproteins of human papillomavirus (HPVs) directly effect cell-cycle control. We hypothesize that regulatory and cell cycle protein expression might be additionally modified in the cervix of HIV/HPV co-infected women. We analyzed the expression of Rb, p27, VEGF and Elf-1 transcriptor factor by immunohistochemistry in 163 paraffin-embeded cervical samples using Tissue Micro-Array (TMA) and correlated this to HIV-1 and HPV infection. HIV/HPV co-infection was associated with a significant increase in expression (p < 0.001) of VEGF and p27 in both low and high grade CIN when compared to the cervices of women infected by HPV alone. Decreased Rb expression was evident with increased CIN grade in the cervices of women infected with HPV alone (p = 0.003 average of cells/mm2 in CIN I: 17.9, CIN II/III: 4.8, and tumor 3.9). Rb expression increased 3-fold for both low and high grade CIN with HPV/HIV-1 co-infection compared to HPV infection alone but did not reach statistical significance. There was a significant increase in Elf-1 expression in HPV+/HIV- women with CIN II/III and tumor (average of cells/mm2 in CIN I: 63.8; CIN II/III: 115.7 and tumor: 112.0, p = 0.005), in comparison to controls. Co-infection of HPV and HIV leads to significant increase in the VEGF and p27 expression when compared to HPV+/HIV-negative infection that could facilitate viral persistence and invasive tumor development.

  9. Economic evaluation of the randomized European Achalasia trial comparing pneumodilation with Laparoscopic Heller myotomy

    NARCIS (Netherlands)

    Moonen, A.; Busch, O.; Costantini, M.; Finotti, E.; Tack, J.; Salvador, R.; Boeckxstaens, G.; Zaninotto, G.

    2017-01-01

    BackgroundA recent multicenter randomized trial in achalasia patients has shown that pneumatic dilation resulted in equivalent relief of symptoms compared to laparoscopic Heller myotomy. Additionally, the cost of each treatment should be also taken in consideration. Therefore, the aim of the present

  10. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears : a randomized controlled trial

    NARCIS (Netherlands)

    Lambers Heerspink, Okke; van Raay, Jos J. A. M.; Koorevaar, Rinco C. T.; van Eerden, Pepijn J. M.; Westerbeek, Robin E.; van 't Riet, Esther; van den Akker-Scheek, Inge; Diercks, Ronald L.

    Background: Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears. The primary aim of this randomized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff

  11. Obstetric outcome of women with uterine anomalies in China.

    Science.gov (United States)

    Zhang, Yan; Zhao, Yang-yu; Qiao, Jie

    2010-02-20

    Congenital uterine anomalies are associated with the highest incidence of reproductive failure and obstetric complications. This study aimed to summarize the clinical characteristics and prenatal outcome of pregnancy in women with congenital uterine malformations. This retrospective study evaluated the fertility and obstetric outcome of 116 inpatients with uterine malformations with pregnancy in Peking University Third Hospital from June 1998 to June 2009. A total of 270 randomly selected pregnant women with a previously confirmed normally shaped uterus as a control group. Student's t test and analysis of variance (ANOVA) were used to compare means for normally distributed variables. The analysis was carried out using the SPSS. Among 21 961 deliveries in Peking University Third Hospital, 116 (0.45%) were in women with uterine anomalies. A septate uterus was present in 43 (37.1%) and the uterus didelphys in 28 (24.2%) of the 116 women identified. Bicornuate uterus, arcuate and unicomate uterus were observed in 12 (10.3%), 18 (15.5%) and 15 (12.9%) patients, respectively. Patients with uterine anomalies had significantly higher rates of malpresentation (38.8%), preterm delivery (19.8%), and cesarean section (78.5%) compared with the group of women with a normal uterus. Patients with uterine anomalies had significantly lower mean birth-weight neonates and a significantly higher incidence of small for gestationalage (SGA) neonates; women with uterus didelphys more frequently required infertility treatment than patients with other uterine anomalies (P unicorns (P < 0.05). Women with congenital uterinemal formation usually have higher incidence of complications during pregnancy and delivery. A septate uterus appears to be associated with poorer obstetric outcomes.

  12. Albendazole versus praziquantel in the treatment of neurocysticercosis: a meta-analysis of comparative trials.

    Directory of Open Access Journals (Sweden)

    Dimitrios K Matthaiou

    Full Text Available BACKGROUND: Neurocysticercosis, infection of the brain with larvae of Taenia solium (pork tapeworm, is one of several forms of human cysticercosis caused by this organism. We investigated the role of albendazole and praziquantel in the treatment of patients with parenchymal neurocysticercosis by performing a meta-analysis of comparative trials of their effectiveness and safety. METHODS AND PRINCIPAL FINDINGS: We performed a search in the PubMed database, Cochrane Database of Controlled Trials, and in references of relevant articles. Six studies were included in the meta-analysis. Albendazole was associated with better control of seizures than praziquantel in the pooled data analysis, when the generic inverse variance method was used to combine the incidence of seizure control in the included trials (patients without seizures/[patients x years at risk] (156 patients in 4 studies, point effect estimate [incidence rate ratio] = 4.94, 95% confidence interval 2.45-9.98. In addition, albendazole was associated with better effectiveness than praziquantel in the total disappearance of cysts (335 patients in 6 studies, random effects model, OR = 2.30, 95% CI 1.06-5.00. There was no difference between albendazole and praziquantel in reduction of cysts, proportion of patients with adverse events, and development of intracranial hypertension due to the administered therapy. CONCLUSIONS: A critical review of the available data from comparative trials suggests that albendazole is more effective than praziquantel regarding clinically important outcomes in patients with neurocysticercosis. Nevertheless, given the relative scarcity of trials, more comparative interventional studies--especially randomized controlled trials--are required to draw a safe conclusion about the best regimen for the treatment of patients with parenchymal neurocysticercosis.

  13. Diagnostic double guarded low-volume uterine lavage in mares

    DEFF Research Database (Denmark)

    Christoffersen, Mette; Brandis, Louise; Samuelsson, Julia

    2014-01-01

    Endometritis constitutes a major problem in the management of broodmares; hence diagnostic tests with a high sensitivity and specificity are desired. We hypothesize that a double guarded uterine flush technique for bacterial culture and cytology is comparable to standard diagnostic tests, the end......Endometritis constitutes a major problem in the management of broodmares; hence diagnostic tests with a high sensitivity and specificity are desired. We hypothesize that a double guarded uterine flush technique for bacterial culture and cytology is comparable to standard diagnostic tests...... (lavage: 11%, swab: 8%, biopsy: 7%) (positive bacterial growth > 4 Colony forming units (CFU)). Positive cytology was less likely to occur when E. coli was isolated from the diagnostic tests compared to the growth of β-hemolytic streptococci. Isolation of pathogens from uterine samples was highly...

  14. Saline contrast hysterosonography in abnormal uterine bleeding : a systematic review and meta-analysis

    NARCIS (Netherlands)

    de Kroon, CD; de Bock, GH; Dieben, SWM; Jansen, FW

    2003-01-01

    Objective To assess the diagnostic accuracy of saline contrast hysterosonography in the evaluation of the uterine cavity in women complaining of abnormal uterine bleeding. Design A systematic review and meta-analysis of diagnostic studies that compared saline contrast hysterosonography to a gold

  15. A Preliminary Study: Human Fibroid Stro-1+/CD44+ Stem Cells Isolated From Uterine Fibroids Demonstrate Decreased DNA Repair and Genomic Integrity Compared to Adjacent Myometrial Stro-1+/CD44+ Cells.

    Science.gov (United States)

    Prusinski Fernung, Lauren E; Al-Hendy, Ayman; Yang, Qiwei

    2018-01-01

    Although uterine fibroids (UFs) continue to place a major burden on female reproductive health, the mechanisms behind their origin remain undetermined. Normal myometrial stem cells may be transformed into tumor-initiating stem cells, causing UFs, due to unknown causes of somatic mutations in MED12, found in up to 85% of sporadically formed UFs. It is well established in other tumor types that defective DNA repair increases the risk of such tumorigenic somatic mutations, mechanisms not yet studied in UFs. To examine the putative cause(s) of this stem cell transformation, we analyzed DNA repair within stem cells from human UFs compared to those from adjacent myometrium to determine whether DNA repair in fibroid stem cells is compromised. Human fibroid (F) and adjacent myometrial (Myo) stem cells were isolated from fresh tissues, and gene expression relating to DNA repair was analyzed. Fibroid stem cells differentially expressed DNA repair genes related to DNA double- (DSBs) and single-strand breaks. DNA damage was measured using alkaline comet assay. Additionally, DNA DSBs were induced in these stem cells and DNA DSB repair evaluated (1) by determining changes in phosphorylation of DNA DSB-related proteins and (2) by determining differences in γ-H2AX foci formation and relative DNA repair protein RAD50 expression. Overall, F stem cells demonstrated increased DNA damage and altered DNA repair gene expression and signaling, suggesting that human F stem cells demonstrate impaired DNA repair. Compromised F stem cell DNA repair may contribute to further mutagenesis and, consequently, further growth and propagation of UF tumors.

  16. Rosemary oil vs minoxidil 2% for the treatment of androgenetic alopecia: a randomized comparative trial.

    Science.gov (United States)

    Panahi, Yunes; Taghizadeh, Mohsen; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

    2015-01-01

    Rosmarinus officinalis L. is a medicinal plant with diverse activities including enhancement microcapillary perfusion. The present study aimed to investigate the clinical efficacy of rosemary oil in the treatment of androgenetic alopecia (AGA) and compare its effects with minoxidil 2%. Patients with AGA were randomly assigned to rosemary oil (n = 50) or minoxidil 2% (n = 50) for a period of 6 months. After a baseline visit, patients returned to the clinic for efficacy and safety evaluations every 3 months. A standardized professional microphotographic assessment of each volunteer was taken at the initial interview and after 3 and 6 months of the trial. No significant change was observed in the mean hair count at the 3-month endpoint, neither in the rosemary nor in the minoxidil group (P > .05). In contrast, both groups experienced a significant increase in hair count at the 6-month endpoint compared with the baseline and 3-month endpoint (P .05). The frequencies of dry hair, greasy hair, and dandruff were not found to be significantly different from baseline at either month 3 or month 6 trial in the groups (P > .05). The frequency of scalp itching at the 3- and 6-month trial points was significantly higher compared with baseline in both groups (P minoxidil group at both assessed endpoints (P < .05). The findings of the present trial provided evidence with respect to the efficacy of rosemary oil in the treatment of AGA.

  17. Fertility after uterine artery embolization for symptomatic multiple fibroids with no other infertility factors.

    Science.gov (United States)

    Torre, Antoine; Fauconnier, Arnaud; Kahn, Vanessa; Limot, Olivier; Bussierres, Laurence; Pelage, Jean Pierre

    2017-07-01

    To evaluate the fertility of women eligible for surgical multiple myomectomy, but who carefully elected a fertility-sparing uterine artery embolization (UAE). Non-comparative open-label trial, on women ≤40 years, presenting with multiple symptomatic fibroids (at least 3, ≥3 cm), immediate pregnancy wish, and no associated infertility factor. Women had a bilateral limited UAE using tris-acryl gelatin microspheres ≥500 μm. Fertility, ovarian reserve, uterus and fibroid sizes, and quality of life questionnaires (UFS-QoL) were prospectively followed. Fifteen patients, aged 34.8 years (95%CI 32.2-37.5, median 36.0, q1-q3 29.4-39.5) were included from November 2008 to May 2012. During the year following UAE, 9 women actively attempting to conceive experienced 5 live-births (intention-to-treat fertility rate 33.3%, 95%CI 11.8%-61.6%). Markers of ovarian reserve remained stable. The symptoms score was reduced by 66% (95%CI 48%-85%) and the quality of life score was improved by 112% (95%CI 21%-204%). Uterine volume was reduced by 38% (95%CI 24%-52%). Women were followed for 43.1 months (95%CI 32.4-53.9), 10 live-births occurred in 8 patients, and 5 patients required secondary surgeries for fibroids. Women without associated infertility factors demonstrated an encouraging capacity to deliver after UAE. Further randomized controlled trials comparing UAE and myomectomy are warranted. • Women without infertility factors showed an encouraging delivery rate after UAE. • For women choosing UAE over abdominal myomectomy, childbearing may not be impaired. • Data are insufficient to definitively recommend UAE as comparable to myomectomy. • Further randomized trials comparing fertility after UAE or myomectomy are warranted.

  18. Enhanced myometrial autophagy in postpartum uterine involution

    Directory of Open Access Journals (Sweden)

    Keng-Fu Hsu

    2014-09-01

    Conclusion: Autophagy of myocytes may play an important role in uterine involution. These results have implications for our understanding of myometrial functional adaptations during pregnancy and the physiological role of autophagy in the uterine remodeling events in the postpartum period.

  19. Effects of 13- cis-retinoic acid on the tamoxifen induced uterine histological changes in the rabbit

    International Nuclear Information System (INIS)

    Hamid, S.; Minhas, L.A.; Khan, M.Y.

    2013-01-01

    Objective: To study the effects of 13-cis-retinoic acid on the tamoxifen induced uterine histological changes in the rabbit. Study Design: Experimental - randomized controlled trial. Place and Duration of study: The study was conducted for 4 months at the department of Anatomy, Army Medical College and National Institute of Health in 2007. Material and Methods: The animals were randomly divided into three groups, a control group A, and two experimental groups B and C, consisting of thirty rabbits each. The experimental groups were treated with tamoxifen only and tamoxifen plus retinoic acid, respectively. The animals were sacrificed after three months. The uteri were then processed for paraffin embedding. Sections were then assessed for the luminal epithelial height, endometrial area and percentage of mitotic figures. Results: The results obtained were suggestive of uterine proliferation by tamoxifen. The adjuvant administration of 13-cis-retinoic acid produced a statistically significant (p = 0.002) inhibitory effect on the tamoxifen induced increase in the area of endometrium, whereas no significant suppressive effect of this drug has been observed on the other parameters when compared with Group B. Conclusion: 13-cis Retinoic acid has not shown a significant role in the reversal of tamoxifen induced changes in the uterine tissue after a short term administration of three months. (author)

  20. Efficacy of adjuvant chemotherapy in early stage uterine leiomyosarcoma: A systematic review and meta-analysis.

    Science.gov (United States)

    Bogani, Giorgio; Fucà, Giovanni; Maltese, Giuseppa; Ditto, Antonino; Martinelli, Fabio; Signorelli, Mauro; Chiappa, Valentina; Scaffa, Cono; Sabatucci, Ilaria; Lecce, Francesca; Raspagliesi, Francesco; Lorusso, Domenica

    2016-11-01

    We sought to review the current evidence in order to test the efficacy of adjuvant chemotherapy in improving disease-free survival in patients affected by early stage uterine leiomyosarcoma. On July 2016, literature was searched in order to identify trials comparing different postoperative adjuvant strategies for patients diagnosed with early stage uterine leiomyosarcoma. Our analysis included 360 patients: 145 (40%), 53 (15%), and 155 (43%) had chemotherapy (with or without radiotherapy), radiotherapy, and observation, respectively. Seven (2%) patients who had radiotherapy with or without chemotherapy were excluded from further analysis in order to reduce risk of biases. Administration of chemotherapy (with or without radiotherapy) did not improve outcomes in comparison to observation (OR: 0.79 (95%CI: 0.48, 1.29)), or radiotherapy (OR: 0.90 (95%CI: 0.42, 1.94)). Loco-regional recurrence rate was similar comparing patients undergoing chemotherapy (with or without radiotherapy) with having observation alone (OR: 0.84 (95%CI: 0.44, 1.60)). Similarly, pooled results suggested that chemotherapy administration did not affect distant recurrence rate in comparison to no chemotherapy (OR: 0.80 (95%CI: 0.50, 1.28)), and observation alone (OR: 0.99 (95%CI: 0.60, 1.64)). However, patients undergoing chemotherapy (with or without radiotherapy) experienced a trend towards lower risk of developing distant recurrences (OR: 0.49 (95%CI: 0.24, 1.03)) and a higher risk of developing loco-regional recurrences (OR: 3.45 (95%CI: 1.02, 11.73)) than patients undergoing radiotherapy. In early stage uterine leiomyosarcoma, the role of adjuvant chemotherapy remains unclear. Owing to the high recurrence rate, even in the early stage of disease, further innovative therapeutic strategies have to be tested. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. 3D DSA findings of uterine artery and its optimal projection position

    International Nuclear Information System (INIS)

    Lu Weifu; Zhang Aiwu; Zhou Chunze; Lu Dong; Xiao Jingkun; Wang Weiyu; Zhang Xingming; Zhang Zhengfeng; Hou Changlong

    2011-01-01

    Objective: to observe the origin site, anatomic features of uterine artery with 3D DSA and to discuss the optimal projection position in order to improve the success rate of super-selective catheterization of uterine artery. Methods: Prospective pelvic angiography was performed in 42 adult females (a total of 84 uterine arteries). 3D DSA was carried out with 206 ° rotation. 3D reconstruction of the obtained images was performed and the angiographic manifestations of the uterine artery were analyzed. The optimal projection position for the displaying of uterine artery was discussed. The quality of images obtained with the projection angle of 15 °-25 °, 25 °-35 ° and 35 °-45 ° was determined and the results were compared with each other. Results: The orifices of all 84 uterine arteries could be well demonstrated on 3D DSA images. The uterine artery was originated from the anterior trunk of internal iliac artery (n=58, 69%), from main stem of internal iliac artery (n=16, 19.1%), from internal pudenda artery (n=8, 9.5%) and from inferior gluteal artery (n=2, 2.4%). The best projection position to show the opening and route of the uterine artery was contralateral oblique view of 25-35 degrees (P<0.05). Conclusion: 3D DSA can clearly display the anatomy of the uterine artery, which is very helpful for the management of super-selective catheterization of uterine artery. The optimal projection position for uterine artery is contralateral oblique view of 25-35 degrees. (authors)

  2. Uterine morphology and peristalsis in women with polycystic ovary syndrome

    International Nuclear Information System (INIS)

    Leonhardt, Henrik; Hellstroem, Mikael; Gull, Berit; Nilsson, Lars; Janson, Per O.; Kishimoto, Keiko; Kataoka, Masako; Stener-Victorin, Elisabet

    2012-01-01

    Background. Polycystic ovary syndrome (PCOS) is associated with chronic oligo-anovulation and high circulating sex hormone levels. Women with PCOS have an increased risk of developing endometrial cancer. In anovulatory women with PCOS a positive relationship between endometrial thickness and endometrial hyperplasia has been observed. Uterine peristalsis, which has been suggested to be of importance for female fertility, has not previously been studied in PCOS. Purpose. To assess whether women with PCOS have altered endometrial thickness, uterine wall morphology, and peristalsis. Material and Methods. In this prospective case-control study 55 women with PCOS (mean age, 29.5 years ± 4.5 SD) and 28 controls (27.6 ± 3.2) were examined using magnetic resonance imaging (MRI), assessing thickness of endometrium, junctional zone (JZ), and myometrium, and evaluating the occurrence, frequency (waves/min), strength (amplitude), pattern, and direction of peristalsis. Uterine morphology was also assessed by transvaginal ultrasonography (TVUS). Results. The endometrium was thinner in PCOS with oligo-amenorrhea compared to controls, also after adjustments for age and BMI (adjusted P = 0.043). There was no difference in thickness of the JZ or the myometrium in cases versus controls. Uterine peristalsis was less commonly observed in women with PCOS than in controls (adjusted P = 0.014). Conclusion. There were no differences in myometrial morphology between PCOS and controls, but the endometrium was thinner in PCOS with oligo-amenorrhea. Based on cine MRI, uterine peristalsis was less common in PCOS than in controls

  3. Uterine morphology and peristalsis in women with polycystic ovary syndrome

    Energy Technology Data Exchange (ETDEWEB)

    Leonhardt, Henrik; Hellstroem, Mikael [Department of Radiology, Institute of Clinical Sciences, Sahlgrenska University Hospital, Sahlgrenska Academy at the University of Gothenburg, Gothenburg (Sweden)], E-mail: henrik.leonhardt@vgregion.se; Gull, Berit; Nilsson, Lars; Janson, Per O. [Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska University Hospital, Sahlgrenska Academy at the University of Gothenburg, Gothenburg (Sweden); Kishimoto, Keiko [Department of Radiology, St Marianna University School of Medicine, Kanagawa (Japan); Kataoka, Masako [Department of Radiology, Kyoto University Hospital, Kyoto (Japan); Stener-Victorin, Elisabet [Institute of Neuroscience and Physiology, Department of Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg (Sweden)

    2012-12-15

    Background. Polycystic ovary syndrome (PCOS) is associated with chronic oligo-anovulation and high circulating sex hormone levels. Women with PCOS have an increased risk of developing endometrial cancer. In anovulatory women with PCOS a positive relationship between endometrial thickness and endometrial hyperplasia has been observed. Uterine peristalsis, which has been suggested to be of importance for female fertility, has not previously been studied in PCOS. Purpose. To assess whether women with PCOS have altered endometrial thickness, uterine wall morphology, and peristalsis. Material and Methods. In this prospective case-control study 55 women with PCOS (mean age, 29.5 years {+-} 4.5 SD) and 28 controls (27.6 {+-} 3.2) were examined using magnetic resonance imaging (MRI), assessing thickness of endometrium, junctional zone (JZ), and myometrium, and evaluating the occurrence, frequency (waves/min), strength (amplitude), pattern, and direction of peristalsis. Uterine morphology was also assessed by transvaginal ultrasonography (TVUS). Results. The endometrium was thinner in PCOS with oligo-amenorrhea compared to controls, also after adjustments for age and BMI (adjusted P = 0.043). There was no difference in thickness of the JZ or the myometrium in cases versus controls. Uterine peristalsis was less commonly observed in women with PCOS than in controls (adjusted P = 0.014). Conclusion. There were no differences in myometrial morphology between PCOS and controls, but the endometrium was thinner in PCOS with oligo-amenorrhea. Based on cine MRI, uterine peristalsis was less common in PCOS than in controls.

  4. Secondary postpartum haemorrhage with uterine artery ...

    African Journals Online (AJOL)

    a left uterine artery PA, which measured 4 cm in diameter, with extravasation of contrast into a pocket that connected to the uterine cavity. After obtaining the patient's consent, selective left uterine artery embolisation was performed with a mixture of Gelfoam and contrast media, followed by one stainless steel coil insertion.

  5. Minimally invasive treatments of uterine fibroids

    NARCIS (Netherlands)

    Voogt, M.J.

    2012-01-01

    This thesis assesses clinical results and technical developments of two minimally invasive treatments for symptomatic uterine fibroids: uterine artery embolization (UAE) and magnetic resonance-guided high intensity focused ultrasound (MR-HIFU). Part I: Uterine artery embolization The results of a

  6. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    Science.gov (United States)

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  7. Uterine-sparing Laparoscopic Resection of Accessory Cavitated Uterine Masses.

    Science.gov (United States)

    Peters, Ann; Rindos, Noah B; Guido, Richard S; Donnellan, Nicole M

    2018-01-01

    To demonstrate surgical techniques utilized during uterine-sparing laparoscopic resections of accessory cavitated uterine masses (ACUMs). ACUMs represent a rare uterine entity observed in premenopausal women suffering from dysmenorrhea and recurrent pelvic pain. The diagnosis is made when an isolated extra-cavitated uterine mass is resected from an otherwise normal appearing uterus with unremarkable endometrial lumen and adnexal structures. Pathologic confirmation requires an accessory cavity lined with endometrial epithelium (and corresponding glands and stroma) filled with chocolate-brown fluid. Adenomyosis must be absent. Although the origin of ACUMs is currently unknown, the most common presentation is a 2-4 cm lateral uterine wall mass at the level of the insertion of the round ligament. Hence it has been hypothesized that gubernaculum dysfunction may be responsible for duplication or persistence of paramesonephric tissue leading to ACUM formation as a new Müllerian anomaly. A stepwise surgical tutorial describing 2 laparoscopic ACUM resections using a narrated video (Canadian Task Force classification III). An academic tertiary care hospital. In this video, we present 2 patients who underwent uterine-sparing laparoscopic resections of their ACUM in order to preserve fertility (Case 1) or avoid the complications and surgical recovery time of a total laparoscopic hysterectomy (Case 2). Case 1 is a 19-year-old, gravida 0, para 0 woman with dysmenorrhea and recurrent pelvic pain who presented for multiple emergency room and outpatient evaluations. Transvaginal ultrasonography was unremarkable except for a 28×30×26mm left lateral uterine mass with peripheral vascular flow that was initially felt to be a leiomyoma or rudimentary uterine horn. MRI imaging, however, demonstrated this mass to be more consistent with an ACUM. This was based on the lack of communication between the lesion and the main uterine cavity exhibited by high T2 signal (compatible with

  8. The application of uterine artery embolization for the treatment of uterine scar pregnancy after cesarean section

    International Nuclear Information System (INIS)

    Chen Yi; Xie Chunming; Yang Minling; Feng Duiping; Pang Ningdong; Cui Liping; Cui Jinxi; Liu Wenying

    2012-01-01

    Objective: To assess the clinical value of uterine arterial embolization (UAE) in treating uterine scar pregnancy after cesarean section. Methods: A total of' 35 cases with cesarean scar pregnancy, admitted to authors' hospital during the period from Jan. 2007 to June 2011, were divided into two groups: embolization group (n=21) and non-embolization group (n=14). By using Seldinger technique, UAE was performed via the right femoral access and gelatin sponge particle was used as embolization agent to occlude the uterine artery. In embolization group, sixteen patients received uterine cavity curettage one or two days after UAE, while five patients received laparotomy or perineotomy surgery to remove the lesions after UAE. In non-embolization group, uterine cavity curettage was performed directly in 8 patients, local injection of' methotrexate followed by uterine cavity curettage was carried out in 3 patients, and direct laparotomy to remove the lesions was adopted in the remaining 3 patients. The blood loss during the procedure, the hospitalization days and the time for β-HCG levels falling to normal were documented. The results were compared between the two groups. Results: UAE was successfully accomplished in all the 21 patients of embolization group and the uterus was preserved in all patients. For the embolization group, the mean hospitalization time was (11.5±3.6) days, and the time for β-HCG levels falling to normal was (18.6±4.9) days. For the non-embolization group, the mean hospitalization time was(20.4±5.2)days, and the time for β-HCG levels falling to normal was (28.7±5.6)days. Hysterectomy had to be carried out in two patients of non-embolization group due to the massive bleeding occurred in therapeutic procedures. Conclusion: For the treatment of cesarean scar pregnancy, UAE is very effective and mini-invasive with high success rate. UAE can preserve the patient's reproductive function, and it also plays a significant role in preventing hemorrhage

  9. Prospective controlled trial comparing colostomy irrigation with "spontaneous-action" method.

    OpenAIRE

    Williams, N S; Johnston, D

    1980-01-01

    Thirty randomly selected patients with permanent colostomies entered a prospective controlled trial comparing colostomy irrigation with spontaneous action. Each patient was interviewed and examined before irrigation was begun and again after the technique had been used for three months. Each then reverted to spontaneous action for a further three months and was then reassessed. Eight patients abandoned irrigation and 22 (73%) adhered to the protocol. Irrigation caused no mishaps or complicati...

  10. Randomized Trial of a Smartphone Mobile Application Compared to Text Messaging to Support Smoking Cessation

    OpenAIRE

    Buller, David B.; Borland, Ron; Bettinghaus, Erwin P.; Shane, James H.; Zimmerman, Donald E.

    2014-01-01

    Background: Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Materials and Methods: Young adult smokers 18–30 years old (n=102) participated in a randomized pretest–posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and qu...

  11. CYberinfrastructure for COmparative effectiveness REsearch (CYCORE): improving data from cancer clinical trials

    OpenAIRE

    Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan

    2010-01-01

    ABSTRACT Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of kn...

  12. Endometrial Polyps and Abnormal Uterine Bleeding (AUB-P): What is the relationship, how are they diagnosed and how are they treated?

    Science.gov (United States)

    Clark, T Justin; Stevenson, Helen

    2017-04-01

    The diagnosis and treatment of endometrial polyps will be familiar to most gynaecologists. However, the aetiology and natural history of these focal intrauterine lesions are yet to be elucidated. This lack of clarity is also true with regard to their clinical significance; whilst endometrial polyps are highly prevalent in all types of abnormal uterine bleeding (AUB), they are also commonly found in women without AUB. These controversies will be discussed along with current thoughts on the diagnosis and treatment of endometrial polyps. Criteria for diagnosis of uterine polyps vary according to the test used, but optimal testing is not yet solidified. Recent data from randomised trials evaluating new and established surgical technologies as well as comparing treatment protocols and settings will be examined. Copyright © 2016. Published by Elsevier Ltd.

  13. Transabdominal color doppler ultrasonography: A relevant approach for assessment of effects of uterine torsion in buffaloes

    Directory of Open Access Journals (Sweden)

    Devender

    2016-08-01

    Full Text Available Aim: The present study was conducted on advanced pregnant buffaloes suffering from uterine torsion to assess the status of fetus and uterus by transabdominal ultrasonography, and the findings were compared with normal advanced pregnant buffaloes. Materials and Methods: The study was conducted on 20 clinical cases of uterine torsion and 20 normal advanced pregnant buffaloes (control group. The lower ventral area just lateral to linea alba (on both sides of the udder in standing animals was scanned transabdominally by the two-dimensional convex transducer for various ultrasonographic findings. The data collected were statistically analyzed by “one-way ANOVA” and “independent sample t-test” using computerized SPSS 16.0 software program. Results: Transabdominal ultrasonography revealed dead fetus in 95% uterine torsion cases and proved useful in imaging internal structures of fetuses while no dead fetus was reported in the control group. Size of umbilicus was found significantly decreased (p0.05 in uterine torsion group. Average thickness of the uterine wall and mean pixel values of fetal fluids (echogenicity were found significantly increased (p<0.05 in uterine torsion affected buffaloes in comparison to control group. Conclusion: Status of fetus (whether live or dead, internal status of uterus, and its contents could be determined by transabdominal ultrasonography in uterine torsion cases and thus determining the prognosis of the uterine torsion cases before going for further manipulations. This will also help in taking all the precautions to avoid death of the fetus.

  14. Posterior Uterine Rupture Causing Fetal Expulsion into the Abdominal Cavity: A Rare Case of Neonatal Survival

    Directory of Open Access Journals (Sweden)

    K. Navaratnam

    2011-01-01

    Full Text Available Introduction. Uterine rupture is a potentially catastrophic complication of vaginal birth after caesarean section. We describe the sixth case of posterior uterine rupture, with intact lower segment scar, and the first neonatal survival after expulsion into the abdominal cavity with posterior rupture. Case Presentation. A multiparous woman underwent prostaglandin induction of labour for postmaturity, after one previous caesarean section. Emergency caesarean section for bradycardia revealed a complete posterior uterine rupture, with fetal and placental expulsion. Upon delivery, the baby required inflation breaths only. The patient required a subtotal hysterectomy but returned home on day 5 postnatally with her healthy baby. Discussion. Vaginal birth after caesarean section constitutes a trial of labour, and the obstetrician must be reactive to labour events. Posterior uterine rupture is extremely rare and may occur without conventional signs. Good maternal and fetal outcome is possible with a prompt, coordinated team response.

  15. Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial.

    Science.gov (United States)

    Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

    2014-12-01

    Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

  16. Umbilical cord mesenchyme stem cell local intramuscular injection for treatment of uterine niche

    Science.gov (United States)

    Fan, Dazhi; Wu, Shuzhen; Ye, Shaoxin; Wang, Wen; Guo, Xiaoling; Liu, Zhengping

    2017-01-01

    Abstract Background: Uterine niche is defined as a triangular anechoic structure at the site of the scar or a gap in the myometrium at the site of a previous caesarean section. The main clinical manifestations are postmenstrual spotting and intrauterine infection, which may seriously affect the daily life of nonpregnant women. Trials have shown an excellent safety and efficacy for the potential of mesenchymal stem cells (MSCs) as a therapeutic option for scar reconstruction. Therefore, this study is designed to investigate the safety and efficacy of using MSCs in the treatment for the uterine niche. Methods/design: This phase II clinical trial is a single-center, prospective, randomized, double-blind, placebo-controlled with 2 arms. One hundred twenty primiparous participants will be randomly (1:1 ratio) assigned to receive direct intramuscular injection of MSCs (a dose of 1∗107 cells in 1 mL of 0.9% saline) (MSCs group) or an identical-appearing 1 mL of 0.9% saline (placebo-controlled group) near the uterine incision. The primary outcome of this trial is to evaluate the proportion of participants at 6 months who is found uterine niche in the uterus by transvaginal utrasonography. Adverse events will be documented in a case report form. The study will be conducted at the Department of Obstetric of Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan. Discussion: This trial is the first investigation of the potential for therapeutic use of MSCs for the management of uterine niche after cesarean delivery. Conclusion: This protocol will help to determine the efficacy and safety of MSCs treatment in uterine niche and bridge the gap with regards to the current preclinical and clinical evidence. Trial registration number: NCT02968459 (Clinical Trials.gov: http://clinicaltrials.gov/). PMID:29095305

  17. Alcohol, indomethacin, and salbutamol. A comparative trial of their use in preterm labor.

    Science.gov (United States)

    Spearing, G

    1979-02-01

    In a comparative trial, ethanol effectively arrested preterm labor for 48 hours for more in 32% of cases, a beta-adrenergic agent (salbutamol) in 60% of cases (not statistically significant), and a combination of ethanol and indomethacin in 70% of cases (statistically significant, P less than 0.5). Labor was delayed for 14 days or more in 36, 60, and 50%, respectively (not statistically significant). The numbers studied were small, and tests of statistical significance were of doubtful value. Salbutamol was more acceptable to patients and the staff than ethanol. The trial was suspended and eventually abandoned due to reports of prostaglandin synthetase inhibitors causing premature closure of the ductus arteriosus. In this series no problems were encountered with the use of indomethacin.

  18. Comparing Amazon Mechanical Turk with unpaid internet resources in online clinical trials

    Directory of Open Access Journals (Sweden)

    Eduardo Bunge

    2018-06-01

    Full Text Available Internet interventions face significant challenges in recruitment and attrition rates are typically high and problematic. Finding innovative yet scientifically valid avenues for attaining and retaining participants is therefore of considerable importance. The main goal of this study was to compare recruitment process and participants characteristics between two similar randomized control trials of mood management interventions. One of the trials (Bunge et al., 2016 was conducted with participants recruited from Amazon's Mechanical Turk (AMT, and the other trial recruited via Unpaid Internet Resources (UIR. Methods: The AMT sample (Bunge et al., 2016 consisted of 765 adults, and the UIR sample (recruited specifically for this study consisted of 329 adult US residents. Participants' levels of depression, anxiety, confidence, motivation, and perceived usefulness of the intervention were assessed. The AMT sample was financially compensated whereas the UIR was not. Results: AMT yielded higher recruitment rates per month (p < .05. At baseline, the AMT sample reported significantly lower depression and anxiety scores (p < .001 and p < .005, respectively and significantly higher mood, motivation, and confidence (all p < .001 compared to the UIR sample. AMT participants spent significantly less time on the site (p < .05 and were more likely to complete follow-ups than the UIR sample (p < .05. Both samples reported a significant increase in their level of confidence and motivation from pre- to post-intervention. AMT participants showed a significant increase in perceived usefulness of the intervention (p < .0001, whereas the UIR sample did not (p = .1642. Conclusions: By using AMT, researchers can recruit very rapidly and obtain higher retention rates; however, these participants may not be representative of the general online population interested in clinical interventions. Considering that AMT and UIR participants

  19. Sterility of the uterine cavity

    DEFF Research Database (Denmark)

    Møller, Birger R.; Kristiansen, Frank V.; Thorsen, Poul

    1995-01-01

    from the same sites. Nearly a quarter of all the patients harbored one or more microorganisms in the uterus, mostly Gardnerella vaginalis, Enterobacter and Streptococcus agalactiae. We found that in a significant number of cases, the uterine cavity is colonized with potentially pathogenic organisms...

  20. Oral misoprostol in the prevention of uterine bleeding after surgical ...

    African Journals Online (AJOL)

    2013-03-13

    Mar 13, 2013 ... Oral misoprostol in the prevention of uterine bleeding after surgical evacuation of first trimester abortion: A comparative study of three uterotonic agents. TM Aramide, AK Olusegun1, AC Akinfolarin2, DF Oriola. Department of Obstetrics and Gynaecology, LAUTECH Teaching Hospital, Ogbomoso, Oyo State, ...

  1. Immunological status of patients with uterine ceroix carcinoma

    International Nuclear Information System (INIS)

    Il'in, I.V.; Dekster, L.I.; Letskij, V.B.

    1979-01-01

    Comparative data on the immunological status of 60 patients with uterine cervix carcinoma 27 of whom were exposed to combined radiotherapy are given. The evaluation of the immunological parameters makes it possible to note a marked affection of the T system by radiant energy. Taking into consideration a significant immunodepressive effect of irradiation it is advisable that immunotherapy by included into the therapeutic regimen

  2. MR Venography of Deep Veins: Changes with Uterine Fibroid Embolization

    International Nuclear Information System (INIS)

    Katsumori, Tetsuya; Kasahara, Toshiyuki; Tsuchida, Yoko; Nara, Yoshinori

    2009-01-01

    Deep veins (DVs) can be compressed by a uterus enlarged with fibroids. The purpose of this study was to assess the degree of luminal narrowing of DVs caused by a myomatous uterus, and the change in DV narrowing in women with symptomatic fibroids after embolization using time-of-flight (TOF)-magnetic resonance venography (MRV). Twenty-nine consecutive women with symptomatic uterine fibroids underwent TOF-MRV and pelvic MRI before and 4 months after embolization. Based on the TOF-MRV, we evaluated the luminal narrowing of three DVs, including the inferior vena cava, and the bilateral common and external iliac veins, and divided the findings into three grades. The scores for each DV were added for each patient (lowest, 0; highest, 6). DV scores and symptom severity (SS) scores were compared between the baseline and 4 months after embolization using the paired t-test. The relationship between DV scores and uterine volume was investigated using Pearson's test. DV scores decreased significantly, from 1.52 ± 1.70 at baseline to 0.93 ± 1.56 at 4 months after embolization (p = 0.004). The uterine volume decreased from 948 ± 647 mL at baseline to 617 ± 417 mL at 4 months after embolization (p < 0.001). DV score correlated with uterine volume (r = 0.856, p < 0.001). SS scores decreased from 54.5 ± 14.6 at baseline to 26.8 ± 15.4 at 4 months after embolization (p < 0.001). In conclusion, the degree of luminal narrowing of DVs caused by a uterus with fibroids is correlated with the uterine volume. Uterine artery embolization may induce an improvement of luminal narrowing of DVs due to a reduction of the myomatous uterus volume.

  3. A randomized trial comparing primary angioplasty versus stent placement for symptomatic intracranial stenosis

    Science.gov (United States)

    Qureshi, Adnan I; Chaudhry, Saqib A; Siddiq, Farhan; Majidi, Shahram; Rodriguez, Gustavo J; Suri, M Fareed K

    2013-01-01

    Background: Both primary angioplasty alone and angioplasty with a self-expanding stent have been compared in non-randomized concurrent clinical studies that suggest equivalent results. However, there is no randomized trial that has compared the two procedures in patients with symptomatic high grade intracranial stenosis. Objective: The primary aim of the randomized trial was to compare the clinical and angiographic efficacy of primary angioplasty and angioplasty followed by stent placement in preventing restenosis, stroke, requirement for second treatment, and death in patients with symptomatic intracranial stenosis. Methods: The study prospectively evaluated efficacy and safety of the two existing neurointerventional techniques for treatment of moderate intracranial stenosis (stenosis ≥ 50%) with documented failure of medical treatment or severe stenosis (≥70%) with or without failure of medical treatment. Results: A total of 18 patients were recruited in the study (mean age [±SD] was 64.7 ± 15.1 years); out of these, 12 were men. Of these 18, 10 were treated with primary angioplasty and 8 were treated with angioplasty followed by self-expanding stent. The technical success rates of intracranial angioplasty and stent placements defined as ability to achieve <30% residual stenosis when assessed by immediate post-procedure angiography was 5 of 10 and 5 of 8 patients, respectively. The total fluoroscopic time (mean [±SD]) was lower in patients undergoing primary angioplasty 37 [±11] min versus those undergoing angioplasty followed by self-expanding stent 42 [±15] min, P = 0.4321. The stroke and death rate within 1 month was very low in both patient groups (1 of 10 versus 0 of 8 patients). One patient randomized to stent placement continued to have recurrent ischemic symptoms requiring another angioplasty in the vertebral artery on post-procedure Day 2. Conclusions: The trial suggests that a randomized trial comparing primary angioplasty to angioplasty

  4. Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial

    Directory of Open Access Journals (Sweden)

    Jessica L. Thomson

    2016-01-01

    Full Text Available Introduction. Delta Healthy Sprouts trial was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reported. Methods. Participants (n=82, enrolled early in their second trimester of pregnancy, were randomly assigned to one of two treatment arms. Gestational weight gain, measured at six monthly home visits, was calculated by subtracting measured weight at each visit from self-reported prepregnancy weight. Weight gain was classified as under, within, or exceeding the Institute of Medicine recommendations based on prepregnancy body mass index. Chi-square tests and generalized linear mixed models were used to test for significant differences in percentages of participants within recommended weight gain ranges. Results. Differences in percentages of participants within the gestational weight gain guidelines were not significant between treatment arms across all visits. Conclusions. Enhancing the gestational nutrition and physical activity components of an existing home visiting program is feasible in a high risk population of primarily low income African American women. The impact of these enhancements on appropriate gestational weight gain is questionable given the more basic living needs of such women. This trial is registered with ClinicalTrials.gov NCT01746394, registered 4 December 2012.

  5. Physical activity and lower limb lymphedema among uterine cancer survivors.

    Science.gov (United States)

    Brown, Justin C; John, Gabriella M; Segal, Saya; Chu, Christina S; Schmitz, Kathryn H

    2013-11-01

    Physical activity (PA) is known to provide physical and mental health benefits to uterine cancer survivors. However, it is unknown if PA is associated with lower limb lymphedema (LLL), an accumulation of protein-rich fluid in the lower limbs. Therefore, we sought to examine the association between PA and LLL in uterine cancer survivors, with a focus on walking. We conducted a cross-sectional study using mailed surveys among uterine cancer survivors who received care at a university-based cancer center. We asked about PA, walking, and LLL symptoms using validated self-report questionnaires. PA was calculated using MET-hours per week, and walking was calculated using blocks per day. The response rate to our survey was 43%. Among the 213 uterine cancer survivors in our survey, 36% were classified as having LLL. Compared with participants who reported trend = 0.003). Stratified analyses suggested the association between PA and LLL existed only among women with body mass index (BMI) trend = 0.007) compared with women with BMI ≥ 30 kg · m (P trend = 0.47). Compared with participants who reported trend trend = 0.007) and women with BMI ≥ 30 kg · m (P trend = 0.03). Participation in higher levels of PA or walking is associated with reduced proportions of LLL in dose-response fashion. These findings should be interpreted as preliminary and should be investigated in future studies.

  6. Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial

    Directory of Open Access Journals (Sweden)

    Mohammad Dehghani Firoozabadi

    2014-01-01

    Full Text Available Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients and conventional treatment group (30 patients. An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months. Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6 and 32.6 (±12.7 years, respectively (P = 0.45. After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80, frequency of migraine attacks (P = 0.63 and duration of attacks per hours (P = 0.48 were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001. Conclusion: There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

  7. A Bayesian Analysis of a Randomized Clinical Trial Comparing Antimetabolite Therapies for Non-Infectious Uveitis.

    Science.gov (United States)

    Browne, Erica N; Rathinam, Sivakumar R; Kanakath, Anuradha; Thundikandy, Radhika; Babu, Manohar; Lietman, Thomas M; Acharya, Nisha R

    2017-02-01

    To conduct a Bayesian analysis of a randomized clinical trial (RCT) for non-infectious uveitis using expert opinion as a subjective prior belief. A RCT was conducted to determine which antimetabolite, methotrexate or mycophenolate mofetil, is more effective as an initial corticosteroid-sparing agent for the treatment of intermediate, posterior, and pan-uveitis. Before the release of trial results, expert opinion on the relative effectiveness of these two medications was collected via online survey. Members of the American Uveitis Society executive committee were invited to provide an estimate for the relative decrease in efficacy with a 95% credible interval (CrI). A prior probability distribution was created from experts' estimates. A Bayesian analysis was performed using the constructed expert prior probability distribution and the trial's primary outcome. A total of 11 of the 12 invited uveitis specialists provided estimates. Eight of 11 experts (73%) believed mycophenolate mofetil is more effective. The group prior belief was that the odds of treatment success for patients taking mycophenolate mofetil were 1.4-fold the odds of those taking methotrexate (95% CrI 0.03-45.0). The odds of treatment success with mycophenolate mofetil compared to methotrexate was 0.4 from the RCT (95% confidence interval 0.1-1.2) and 0.7 (95% CrI 0.2-1.7) from the Bayesian analysis. A Bayesian analysis combining expert belief with the trial's result did not indicate preference for one drug. However, the wide credible interval leaves open the possibility of a substantial treatment effect. This suggests clinical equipoise necessary to allow a larger, more definitive RCT.

  8. Iohexol and iopamidol myelography in the dog: a clinical trial comparing adverse effects and myelographic quality

    International Nuclear Information System (INIS)

    Widmer, W.R.; Blevins, W.E.; Jakovljevic, S.; Teclaw, R.F.; Han, C.M.; Hurd, C.D.

    1992-01-01

    In a blind clinical trial, adverse effects after iohexol and iopamidol myelography were evaluated in 151 dogs. Eighty-one dogs were given iohexol (240 mgI/ml) and 70 dogs were given iopamidol (200 mgI/ml) by pre-determined assignment. Each dog was evaluated postmyelographically for seizures, hyperthermia, prolonged recovery from anesthesia and intensification of pre-existing neural signs. Myelographic quality was evaluated with a subjective scoring method. In comparing iohexol and iopamidol groups, there was not a statistically significant difference in the incidence of adverse effects or in myelographic quality. Iopamidol and iohexol appeared to be equally efficacious for routine canine myelography

  9. Randomized Controlled Trial Comparing Open Versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The CAPD I Trial.

    Science.gov (United States)

    van Laanen, Jorinde H H; Cornelis, Tom; Mees, Barend M; Litjens, Elisabeth J; van Loon, Magda M; Tordoir, Jan H M; Peppelenbosch, Arnoud G

    2018-01-01

    had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome. Copyright © 2018 International Society for Peritoneal Dialysis.

  10. Comparison of simple uterine manipulator-injector (SUMI with the Cohen cannula in gynecologic laparoscopy

    Directory of Open Access Journals (Sweden)

    Karim Hassanein Abd-El-Maeboud

    2011-12-01

    Conclusion: Although SUMI takes longer to insert, the ease of its use is comparable with the Cohen cannula. A major advantage of its use is increased range of uterine maneuverability with better surgical field exposure.

  11. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance.

    Science.gov (United States)

    Titov, Nickolai; Andrews, Gavin; Davies, Matthew; McIntyre, Karen; Robinson, Emma; Solley, Karen

    2010-06-08

    Internet-based cognitive behavioural therapy (iCBT) for depression is effective when guided by a clinician, less so if unguided. Would guidance from a technician be as effective as guidance from a clinician? Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II) and the Patient Health QUESTIONnaire-9 Item (PHQ-9). Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (ptechnician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program. Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and acceptability of technician-assisted iCBT programs for depression. This form of treatment has potential to increase the capacity of existing mental health services. Australian New

  12. Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial.

    Science.gov (United States)

    Molt, Mats; Toksvig-Larsen, Sören

    2014-10-01

    The objective of this study was to compare the early migration of the cruciate retaining and posterior stabilising versions of the recently introduced Triathlon™ total knee system, with a view to predicting long term fixation performance. Sixty patients were prospectively randomised to receive either Triathlon™ posterior stabilised cemented knee prosthesis or Triathlon™ cruciate retaining cemented knee prosthesis. Tibial component migration was measured by radiostereometric analysis postoperatively and at three months, one year and two years. Clinical outcome was measured by the American Knee Society Score and Knee Osteoarthritis and Injury Outcome Score. There were no differences in rotation around the three coordinal axes or in the maximum total point motion (MTPM) during the two year follow-up. The posterior stabilised prosthesis had more posterior-anterior translation at three months and one year and more caudal-cranial translation at one year and two years. There were no differences in functional outcome between the groups. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability. Level I. Article focus: This was a prospective randomised trial aiming to compare the single radius posterior stabilised (PS) Triathlon™ total knee arthroplasty (TKA) to the cruciate retaining Triathlon™ TKA system with regard to fixation. Strengths and limitations of this study: Strength of this study was that it is a randomised prospective trial using an objective measuring tool. The sample size of 25-30 patients was reportedly sufficient for the screening of implants using RSA [1]. ClinicalTrials.gov Identifier: NCT00436982. Copyright © 2014 Elsevier B.V. All rights reserved.

  13. The effects of Red Bull energy drink compared with caffeine on cycling time-trial performance.

    Science.gov (United States)

    Quinlivan, Alannah; Irwin, Christopher; Grant, Gary D; Anoopkumar-Dukie, Sheilandra; Skinner, Tina; Leveritt, Michael; Desbrow, Ben

    2015-10-01

    This study investigated the ergogenic effects of a commercial energy drink (Red Bull) or an equivalent dose of anhydrous caffeine in comparison with a noncaffeinated control beverage on cycling performance. Eleven trained male cyclists (31.7 ± 5.9 y 82.3 ± 6.1 kg, VO2max = 60.3 ± 7.8 mL · kg-1 · min-1) participated in a double-blind, placebo-controlled, crossover-design study involving 3 experimental conditions. Participants were randomly administered Red Bull (9.4 mL/kg body mass [BM] containing 3 mg/kg BM caffeine), anhydrous caffeine (3 mg/kg BM given in capsule form), or a placebo 90 min before commencing a time trial equivalent to 1 h cycling at 75% peak power output. Carbohydrate and fluid volumes were matched across all trials. Performance improved by 109 ± 153 s (2.8%, P = .039) after Red Bull compared with placebo and by 120 ± 172 s (3.1%, P = .043) after caffeine compared with placebo. No significant difference (P > .05) in performance time was detected between Red Bull and caffeine treatments. There was no significant difference (P > .05) in mean heart rate or rating of perceived exertion among the 3 treatments. This study demonstrated that a moderate dose of caffeine consumed as either Red Bull or in anhydrous form enhanced cycling time-trial performance. The ergogenic benefits of Red Bull energy drink are therefore most likely due to the effects of caffeine, with the other ingredients not likely to offer additional benefit.

  14. Radiotherapy Results of Early Uterine Cervix Cancer

    International Nuclear Information System (INIS)

    Choi, Doo Ho; Huh, Seung Jae

    1996-01-01

    Purpose : This study was done to analyze survivals, patterns of failure, and complications of early uterine cervix cancer after curative radiotherapy. Methods and Materials : Eighty patients with uterine cervix cancer FIGO Stage IB (48 cases) and Stage IIA (32 cases) treated with radiotherapy were analyzed retrospectively. Patients were treated from November 1985 to May 1993, and minimum follow up period was 24 months. and 6 cases were lost to follow up. All of them were treated with external radiotherapy and different fractions of high dose rate intracavitary radiotherapy. Survival rates, failure patterns, complication rates and degrees of severity were analyzed according to several factors. Results : Overall 5 year survival rate and relapse free survival rate were 72.3%, and 72.8% respectively. Prognostic factors were stage, size, pathology, RT response and there was no significant survival difference among the reasons of radiotherapy choice. There were 19 cases of treatment failure, another 3 cases were not tumor related death, and most of treatment related failure occurred within 24 months. Late complication rate of bladder and rectum were 8.8%, 15% respectively, frequency and severity of complication were correlated with ICR fractionation dose and total dose. Conclusion : These results showed that survival rates of early stage radiation treated cervix cancer patients were comparable to surgical series, but more aggressive treatment methods needed for stage IIA poor prognostic patients, To decrease late complication, choice of proper ICR dose and meticulous vaginal packing is needed

  15. Clinical and laboratory characteristics of women with uterine leiomiyoma

    Directory of Open Access Journals (Sweden)

    Özgür ÖZKUL

    2009-06-01

    Full Text Available The aim of this study was to compare clinical and laboratory findings of women with or without uterine leiomyoma.Study group consisted of 82 women with uterine leiomyoma and the control group comprised 42 healthy women. Women’s age, gravity, parity, blood groups, pattern of menstrual cycles, complaints at presentation, fertility, ultrasonographical findings, surgical operations and thyroid function tests were evaluated.There were no significant differences in blood group distribution, gravity, parity and thyroid function test results between the patients and the control subjects (P>0.05. A significant difference was found in the complaints at presentation between two groups (P<0.001. Mentrual cycles irregularity was more frequently found in the patients compared with the controls (57.3% vs. 42.9%, respectively, P=0.009. Although no infertile woman was found in the control group, 8.5% of patients were found to have infertility. The sensitivity of ultrasonography was found to be 97.6%. Except for the existence of higher infertility rate and the menstrual cycles irregularities, no significant difference was found in the clinical and laboratory findings between women with or without uterine leiomyoma. Therefore, physical examination and imaging methods are remained as the most important diagnostic tools for uterine leiomyoma.

  16. Dietary melatonin alters uterine artery hemodynamics in pregnant Holstein heifers.

    Science.gov (United States)

    Brockus, K E; Hart, C G; Gilfeather, C L; Fleming, B O; Lemley, C O

    2016-04-01

    The objective was to examine uterine artery hemodynamics and maternal serum profiles in pregnant heifers supplemented with dietary melatonin (MEL) or no supplementation (CON). In addition, melatonin receptor-mediated responses in steroid metabolism were examined using a bovine endometrial epithelial culture system. Twenty singleton pregnant Holstein heifers were supplemented with 20 mg of melatonin (n = 10) or no melatonin supplementation (control; n = 10) from days 190 to 262 of gestation. Maternal measurements were recorded on days 180 (baseline), 210, 240, and 262 of gestation. Total uterine blood flow was increased by 25% in the MEL-treated heifers compared with the CON. Concentrations of progesterone were decreased in MEL vs CON heifers. Total serum antioxidant capacity was increased by 43% in MEL-treated heifers when compared with CON. Activity of cytochrome P450 1A, 2C, and superoxide dismutase was increased in bovine endometrial epithelial cells treated with melatonin, whereas the melatonin receptor antagonist, luzindole, negated the increase in cytochrome P450 2C activity. Moreover, estradiol or progesterone treatment altered bovine uterine melatonin receptor expression, which could potentiate the melatonin-mediated responses during late gestation. The observed increase in total uterine blood flow during melatonin supplementation could be related to its antioxidant properties. Compromised pregnancies are typically accompanied by increased oxidative stress; therefore, melatonin could serve as a therapeutic supplementation strategy. This could lead to further fetal programming implications in conjunction with offspring growth and development postnatally. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Comparing methods to combine functional loss and mortality in clinical trials for amyotrophic lateral sclerosis

    Directory of Open Access Journals (Sweden)

    van Eijk RPA

    2018-03-01

    Full Text Available Ruben PA van Eijk,1 Marinus JC Eijkemans,2 Dimitris Rizopoulos,3 Leonard H van den Berg,4,* Stavros Nikolakopoulos5,* 1Department of Neurology, University Medical Center Utrecht, Utrecht, the Netherlands; 2Department of Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands; 3Department of Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlands; 4Department of Neurology, University Medical Center Utrecht, Utrecht, the Netherlands; 5Department of Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands *These authors contributed equally to this work Objective: Amyotrophic lateral sclerosis (ALS clinical trials based on single end points only partially capture the full treatment effect when both function and mortality are affected, and may falsely dismiss efficacious drugs as futile. We aimed to investigate the statistical properties of several strategies for the simultaneous analysis of function and mortality in ALS clinical trials. Methods: Based on the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT database, we simulated longitudinal patterns of functional decline, defined by the revised amyotrophic lateral sclerosis functional rating scale (ALSFRS-R and conditional survival time. Different treatment scenarios with varying effect sizes were simulated with follow-up ranging from 12 to 18 months. We considered the following analytical strategies: 1 Cox model; 2 linear mixed effects (LME model; 3 omnibus test based on Cox and LME models; 4 composite time-to-6-point decrease or death; 5 combined assessment of function and survival (CAFS; and 6 test based on joint modeling framework. For each analytical strategy, we calculated the empirical power and sample size. Results: Both Cox and LME models have increased false-negative rates when treatment exclusively affects either function or survival. The joint model has superior power compared to other strategies. The composite end point

  18. Comparative effectiveness of injection therapies in lateral epicondylitis: a systematic review and network meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Krogh, Thøger Persson; Bartels, Else Marie; Ellingsen, Torkell; Stengaard-Pedersen, Kristian; Buchbinder, Rachelle; Fredberg, Ulrich; Bliddal, Henning; Christensen, Robin

    2013-06-01

    Injection therapy with glucocorticoids has been used since the 1950s as a treatment strategy for lateral epicondylitis (tennis elbow). Lately, several novel injection therapies have become available. To assess the comparative effectiveness and safety of injection therapies in patients with lateral epicondylitis. Systematic review and meta-analysis. Randomized controlled trials comparing different injection therapies for lateral epicondylitis were included provided they contained data for change in pain intensity (primary outcome). Trials were assessed using the Cochrane risk of bias tool. Network (random effects) meta-analysis was applied to combine direct and indirect evidence within and across trial data using the final end point reported in the trials, and results for the arm-based network analyses are reported as standardized mean differences (SMDs). Seventeen trials (1381 participants; 3 [18%] at low risk of bias) assessing injection with 8 different treatments-glucocorticoid (10 trials), botulinum toxin (4 trials), autologous blood (3 trials), platelet-rich plasma (2 trials), and polidocanol, glycosaminoglycan, prolotherapy, and hyaluronic acid (1 trial each)-were included. Pooled results (SMD [95% confidence interval]) showed that beyond 8 weeks, glucocorticoid injection was no more effective than placebo (-0.04 [-0.45 to 0.35]), but only 1 trial (which did not include a placebo arm) was at low risk of bias. Although botulinum toxin showed marginal benefit (-0.50 [-0.91 to -0.08]), it caused temporary paresis of finger extension, and all trials were at high risk of bias. Both autologous blood (-1.43 [-2.15 to -0.71]) and platelet-rich plasma (-1.13 [-1.77 to -0.49]) were also statistically superior to placebo, but only 1 trial was at low risk of bias. Prolotherapy (-2.71 [-4.60 to -0.82]) and hyaluronic acid (-5.58 [-6.35 to -4.82]) were both more efficacious than placebo, whereas polidocanol (0.39 [-0.42 to 1.20]) and glycosaminoglycan (-0.32 [-1.02 to 0

  19. Risk Factors for Uterine Atony/Postpartum Hemorrhage Requiring Treatment after Vaginal Delivery

    Science.gov (United States)

    Wetta, Luisa A; Szychowski, Jeff M; Seals, Ms. Samantha; Mancuso, Melissa S; Biggio, Joseph R; Tita, Alan TN

    2013-01-01

    Objective To identify risk factors for uterine atony or hemorrhage. Study Design Secondary analysis of a 3-arm double-blind randomized trial of different dose-regimens of oxytocin to prevent uterine atony after vaginal delivery. The primary outcome was uterine atony or hemorrhage requiring treatment. Twenty-one potential risk factors were evaluated. Logistic regression was used to identify independent risk factors using 2 complementary pre-defined model selection strategies. Results Among 1798 women randomized to 10, 40 or 80U prophylactic oxytocin after vaginal delivery, treated uterine atony occurred in 7%. Hispanic (OR 2.1; 95% CI 1.3–3.4) and non-Hispanic whites (OR 1.6; 95% CI 1.0–2.5), preeclampsia (OR 3.2; 95% CI 2.0–4.9) and chorioamnionitis (OR 2.8; 95% CI 1.6–5.0) were consistent independent risk factors. Other risk factors based on the specified selection strategies were obesity, induction/augmentation of labor, twins, hydramnios, anemia, and arrest of descent. Amnioinfusion appeared to be protective against uterine atony (OR 0.53; 95% CI 0.29–0.98). Conclusion Independent risk factors for uterine atony requiring treatment include Hispanic and non-Hispanic white ethnicity, preeclampsia and chorioamnionitis. PMID:23507549

  20. Efficacy of Combined Laparoscopic and Hysteroscopic Repair of Post-Cesarean Section Uterine Diverticulum: A Retrospective Analysis

    Directory of Open Access Journals (Sweden)

    Cuilan Li

    2016-01-01

    Full Text Available Background. Diverticulum, one of the long-term sequelae of cesarean section, can cause abnormal uterine bleeding and increase the risk of uterine scar rupture. In this study, we aimed to evaluate the efficacy of combined laparoscopic and hysteroscopic repair, a newly occurring method, treating post-cesarean section uterine scar diverticulum. Methods. Data relating to 40 patients with post-cesarean section uterine diverticulum who underwent combined laparoscopic and hysteroscopic repair were retrospectively analyzed. Preoperative clinical manifestations, size of uterine defects, thickness of the lower uterine segment (LUS, and duration of menstruation were compared with follow-up findings at 1, 3, and 6 months after surgery. Results. The average preoperative length and width of uterine diverticula and thickness of the lower uterine segment were recorded and analyzed. The average durations of menstruations at 1, 3, and 6 months after surgery were significantly shorter than the preoperative one (p<0.05, respectively. At 6 months after surgery, the overall success improvement rate of surgery was 90% (36/40. Three patients (3/40 = 7.5% developed partial improvement, and 1/40 (2.5% was lost to follow-up. Conclusions. Our findings showed that combined treatment with laparoscopy and hysteroscopy was an effective method for the repair of post-cesarean section uterine diverticulum.

  1. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Geladé, Katleen; Janssen, Tieme W. P.; Bink, Marleen; van Mourik, Rosa; Maras, Athanasios; Oosterlaan, Jaap

    2016-01-01

    The efficacy of neurofeedback as a treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, is still an intensely debated subject. The current randomized controlled trial compared neurofeedback to (1) optimally

  2. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Gelade, K.; Janssen, T.W.P.; Bink, M.; van Mourik, R.; Maras, A.; Oosterlaan, J.

    2016-01-01

    Objective: The efficacy of neurofeedback as treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, are still intensely debated subjects. The current randomised controlled trial compared neurofeedback to (1) optimally

  3. The IDvIP Trial: A two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia

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    Thomas Peter

    2011-07-01

    Full Text Available Abstract Background Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. Methods The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score Discussion If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour. Trial Registration ISRCTN14898678 Eudra No: 2006-003250-18, REC Reference No: 06/Q1702/95, MHRA Authorisation No: 1443/0001/001-0001, NIHR UKCRN reference 6895, RfPB grant

  4. Application of detergents or high hydrostatic pressure as decellularization processes in uterine tissues and their subsequent effects on in vivo uterine regeneration in murine models.

    Directory of Open Access Journals (Sweden)

    Erna G Santoso

    Full Text Available Infertility caused by ovarian or tubal problems can be treated using In Vitro Fertilization and Embryo Transfer (IVF-ET; however, this is not possible for women with uterine loss and malformations that require uterine reconstruction for the treatment of their infertility. In this study, we are the first to report the usefulness of decellularized matrices as a scaffold for uterine reconstruction. Uterine tissues were extracted from Sprague Dawley (SD rats and decellularized using either sodium dodecyl sulfate (SDS or high hydrostatic pressure (HHP at optimized conditions. Histological staining and quantitative analysis showed that both SDS and HHP methods effectively removed cells from the tissues with, specifically, a significant reduction of DNA contents for HHP constructs. HHP constructs highly retained the collagen content, the main component of extracellular matrices in uterine tissue, compared to SDS constructs and had similar content levels of collagen to the native tissue. The mechanical strength of the HHP constructs was similar to that of the native tissue, while that of the SDS constructs was significantly elevated. Transmission electron microscopy (TEM revealed no apparent denaturation of collagen fibers in the HHP constructs compared to the SDS constructs. Transplantation of the decellularized tissues into rat uteri revealed the successful regeneration of the uterine tissues with a 3-layer structure 30 days after the transplantation. Moreover, a lot of epithelial gland tissue and Ki67 positive cells were detected. Immunohistochemical analyses showed that the regenerated tissues have a normal response to ovarian hormone for pregnancy. The subsequent pregnancy test after 30 days transplantation revealed successful pregnancy for both the SDS and HHP groups. These findings indicate that the decellularized matrix from the uterine tissue can be a potential scaffold for uterine regeneration.

  5. UTERINE ARTERIOVENOUS MALFORMATION: A CASE REPORT

    OpenAIRE

    Chandrashekar Murthy; Kiran

    2014-01-01

    Uterine arteriovenous malformation (AVM) is a rare condition, with less than 100 cases reported in the literature. Despite it being rare, it is a potentially life threatening disease. This case report describes 31- year-old women who presented with abnormal uterine bleeding. Trans abdominal sonography, colour and spectral Doppler imaging was performed, diagnosis was confirmed by non- invasive MRI scan. Laparoscopic bilateral uterine artery ligation was done successfully.

  6. Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial

    Science.gov (United States)

    Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

    2018-01-01

    Abstract Objectives To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Design Prospective, randomized, 52 week, single blind comparative effectiveness trial. Setting Urban tertiary care academic hospital in the United States between March 2012 and September 2016. Participants 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Interventions Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. Main outcome measures The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient’s global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. Results FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient’s global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with

  7. Does fertility treatment increase the risk of uterine cancer? A meta-analysis.

    Science.gov (United States)

    Saso, Srdjan; Louis, Louay S; Doctor, Farah; Hamed, Ali Hassan; Chatterjee, Jayanta; Yazbek, Joseph; Bora, Shabana; Abdalla, Hossam; Ghaem-Maghami, Sadaf; Thum, Meen-Yau

    2015-12-01

    An ongoing debate over the last two decades has focused on whether fertility treatment in women may lead to an increased risk of developing uterine cancer over a period of time. Uterine cancer (including mainly endometrial carcinoma and the less common uterine sarcoma) is the commonest reproductive tract cancer and the fourth commonest cancer in women in the UK. Our objective was to assess the association between fertility drugs used in the treatment of female infertility (both as an independent therapy and during in vitro fertilization cycles) and the development of uterine cancer. A literature search was performed using Medline, Embase, Cochrane Library and Google Scholar databases for comparative studies until December 2014 to investigate a clinical significance of fertility treatment on the incidence of developing uterine cancer. General and MESH search headings, as well as the 'related articles' function were applied. All comparative studies of 'fertility treatment' versus 'non-fertility treatment' reporting the incidence of uterine cancer as an outcome were included. Uterine cancer incorporated the following terms: uterine cancer, uterine body tumours, uterine sarcomas and endometrial cancers. The primary outcome of interest was the uterine cancer incidence in all 'fertility treatment' versus 'non-fertility treatment' patient groups. Secondary outcomes of interest were: (a) uterine cancer incidence in 'IVF' versus 'non-IVF' patient groups; and (b) uterine cancer incidence according to type of fertility drug used. Odds ratio was the summary statistic. Random-effects modelling, graphical exploration and sensitivity analysis were used to evaluate the consistency of the calculated treatment effect. We included six studies in our final analysis, which comprised 776,224 patients in total. Of these, 103,758 had undergone fertility treatment and 672,466 had not. There was 100% agreement between the two reviewers regarding the data extraction. All the studies

  8. Review literature on uterine carcinosarcoma

    Directory of Open Access Journals (Sweden)

    Rajendra Singh

    2014-01-01

    Full Text Available Carcinosarcoma of the uterus is a rare gynaecological neoplasm, which is also known as malignant mixed mesodermal tumor. Traditionally this tumour has been regarded as a subtype of uterine sarcoma, and its origin remains controversial. The exact nature and prognosis was not clear in the past. It is believed that uterine carcinosarcoma have a Mullerian duct origin and have a capacity to differentiate into various mesenchymal and epithelial components. Regarding the histogensis, various theories have been given; of which ′conversion theory′ was broadly accepted. Carcinosarcoma are mostly of monoclonal origin with the carcinomatous component being the driving force. This type of tumor is broadly divided into two groups, homologous and heterologous, depending on the characteristics of the stroma or mesenchymal components of endometrial tissue. It is more frequent in black women and postmenopausal women. Radiation is a possible etiological factor but the exact etiology is not known yet. However, tamoxifen may induce carcinogenesis in some patients. Its clinical feature is very similar to endometrial carcinoma i.e. postmenopausal vaginal bleeding, have a very aggressive behavior and a poor prognosis. This pelvic malignancy is treated by multimodality therapy including surgery, chemotherapy and radiotherapy. Here we are reviewing old concepts about the disease and modern understandings of the origin, classification, pathogenesis and recent advances in the treatment of the uterine carcinosarcoma.

  9. Abnormal uterine bleeding in perimenopause.

    Science.gov (United States)

    Goldstein, S R; Lumsden, M A

    2017-10-01

    Abnormal uterine bleeding is one of the commonest presenting complaints encountered in a gynecologist's office or primary-care setting. The wider availability of diagnostic tools has allowed prompt diagnosis and treatment of an increasing number of menstrual disorders in an office setting. This White Paper reviews the advantages and disadvantages of transvaginal ultrasound, blind endometrial sampling and diagnostic hysteroscopy. Once a proper diagnosis has been established, appropriate therapy may be embarked upon. Fortunately, only a minority of such patients will have premalignant or malignant disease. When bleeding is sufficient to cause severe anemia or even hypovolemia, prompt intervention is called for. In most of the cases, however, the abnormal uterine bleeding will be disquieting to the patient and significantly affect her 'quality of life'. Sometimes, reassurance and expectant management will be sufficient in such patients. Overall, however, in cases of benign disease, some intervention will be required. The use of oral contraceptive pills especially those with a short hormone-free interval, the insertion of the levonorgestrel intrauterine system, the incorporation of newer medical therapies including antifibrinolytic drugs and selective progesterone receptor modulators and minimally invasive treatments have made outpatient therapy increasingly effective. For others, operative hysteroscopy and endometrial ablation are proven therapeutic tools to provide both long- and short-term relief of abnormal uterine bleeding, thus avoiding, or deferring, hysterectomy.

  10. FLOW (finding lasting options for women): multicentre randomized controlled trial comparing tampons with menstrual cups.

    Science.gov (United States)

    Howard, Courtney; Rose, Caren Lee; Trouton, Konia; Stamm, Holly; Marentette, Danielle; Kirkpatrick, Nicole; Karalic, Sanja; Fernandez, Renee; Paget, Julie

    2011-06-01

    To determine whether menstrual cups are a viable alternative to tampons. Randomized controlled trial. Prince George, Victoria, and Vancouver, BC. A total of 110 women aged 19 to 40 years who had previously used tampons as their main method of menstrual management. Participants were randomized into 2 groups, a tampon group and a menstrual cup group. Using online diaries, participants tracked 1 menstrual cycle using their regular method and 3 menstrual cycles using the method of their allocated group. Overall satisfaction; secondary outcomes included discomfort, urovaginal infection, cost, and waste. Forty-seven women in each group completed the final survey, 5 of whom were subsequently excluded from analysis (3 from the tampon group and 2 from the menstrual cup group). Overall satisfaction on a 7-point Likert scale was higher for the menstrual cup group than for the tampon group (mean [standard deviation] score 5.4 [1.5] vs 5.0 [1.0], respectively; P=.04). Approximately 91% of women in the menstrual cup group said they would continue to use the cup and recommend it to others. Women used a median of 13 menstrual products per cycle, or 169 products per year, which corresponds to approximately 771,248,400 products used annually in Canada. Estimated cost for tampon use was $37.44 a year (similar to the retail cost of 1 menstrual cup). Subjective vaginal discomfort was initially higher in the menstrual cup group, but the discomfort decreased with continued use. There was no significant difference in physician-diagnosed urovaginal symptoms between the 2 groups. Both of the menstrual management methods evaluated were well tolerated by subjects. Menstrual cups are a satisfactory alternative to tampons and have the potential to be a sustainable solution to menstrual management, with moderate cost savings and much-reduced environmental effects compared with tampons. Trial registration number C06-0478 (ClinicalTrials.gov).

  11. Mechanistic Study of the Inhibitory Effect of Kaempferol on Uterine Fibroids In Vitro.

    Science.gov (United States)

    Li, Yanxia; Ding, Zhaoxia; Wu, Chuanzhong

    2016-12-08

    BACKGROUND This study examined the effect of kaempferol on uterine fibroids in vitro and the underlying mechanism, and investigated the potential of kaempferol as a clinical drug for the treatment of uterine fibroids. MATERIAL AND METHODS Uterine fibroid tissue and surrounding smooth muscle tissue were collected for primary culture. Different concentrations of kaempferol (12 μM, 24 μM, and 48 μM) were used to treat the cells for 24, 48, and 72 hours. Ethanol was used in the control group. A CCK-8 colorimetric assay was used to detect cell proliferation. Real-time PCR and immunoblot were used to detect estrogen receptor (ER), insulin-like growth factor-1 (IGF-1), and vascular endothelial growth factor (VEGF) levels in mRNA and protein. RESULTS The differences in proliferation at different time points and concentrations of kaempferol were statistically significant. The inhibitory effect of kaempferol on mRNA levels of ER and IGF, and protein levels of ER, VEGF, and IGF-1 were positively correlated with kaempferol concentration. Changes in kaempferol concentration showed no effect on VEGF mRNA expression. Treatment with kaempferol significantly lowered myocardin levels in uterine fibroid tissue compared to normal uterine smooth muscle (PKaempferol might be used for clinical treatment of uterine fibroids due to its inhibitory effect on the proliferation of uterine fibroids cells.

  12. Uterine Fibroid Embolization Can Still Be Improved: Observations on Post-Procedure Magnetic Resonance Imaging

    International Nuclear Information System (INIS)

    Dorenberg, E.J.; Novakovic, Z.; Smith, H.J.; Hafsahl, G.; Jakobsen, J.Aa.

    2005-01-01

    PURPOSE: To evaluate the efficacy and completeness of uterine fibroid embolization (UFE) measured by changes in volume and signal intensity at magnetic resonance imaging (MRI), and to compare with clinical outcome. MATERIAL AND METHODS: 40 women with symptomatic uterine fibroids underwent bilateral uterine artery embolization. At MRI studies, including post-contrast sequences before and repeatedly after treatment, the uterus and dominant fibroids were evaluated for volume, location, and contrast enhancement. Prior to treatment, all myomas showed significant contrast enhancement. The mean uterine volume was 929 ml. Clinical examinations with emphasis on menorrhagia, pelvic pain, and urinary dysfunction were performed before and 6 and 12 months after treatment. RESULTS: UFE was bilaterally successful in 38 patients. After UFE, MRI showed no enhancement of myomas in 30 patients. In 8 patients, post-procedural MRI revealed partially remaining vascularization of fibroids despite angiographically complete embolization of the uterine arteries. On average, uterine volume decreased by 46.2% at 12 months. There was significant improvement of symptoms in the majority of patients, but slightly less improvement in patients with partially remaining vascularization of myomas. CONCLUSION: UFE causes significant volume reduction of myomas and clinical improvement. MRI can reveal remaining vascularization in myomas despite angiographically complete embolization of uterine arteries

  13. Dextrose saline compared with normal saline rehydration of hyperemesis gravidarum: a randomized controlled trial.

    Science.gov (United States)

    Tan, Peng Chiong; Norazilah, Mat Jin; Omar, Siti Zawiah

    2013-02-01

    To compare 5% dextrose-0.9% saline against 0.9% saline solution in the intravenous rehydration of hyperemesis gravidarum. Women at their first hospitalization for hyperemesis gravidarum were enrolled on admission to the ward and randomly assigned to receive either 5% dextrose-0.9% saline or 0.9% saline by intravenous infusion at a rate 125 mL/h over 24 hours in a double-blind trial. All participants also received thiamine and an antiemetic intravenously. Oral intake was allowed as tolerated. Primary outcomes were resolution of ketonuria and well-being (by 10-point visual numerical rating scale) at 24 hours. Nausea visual numerical rating scale scores were obtained every 8 hours for 24 hours. Persistent ketonuria rates after the 24-hour study period were 10 of 101 (9.9%) compared with 11 of 101 (10.9%) (P>.99; relative risk 0.9, 95% confidence interval 0.4-2.2) and median (interquartile range) well-being scores at 24 hours were 9 (8-10) compared with 9 (8-9.5) (P=.73) in the 5% dextrose-0.9% saline and 0.9% saline arms, respectively. Repeated measures analysis of variance of the nausea visual numerical rating scale score as assessed every 8 hours during the 24-hour study period showed a significant difference in favor of the 5% dextrose-0.9% saline arm (P=.046) with the superiority apparent at 8 and 16 hours, but the advantage had dissipated by 24 hours. Secondary outcomes of vomiting, resolution of hyponatremia, hypochloremia and hypokalemia, length of hospitalization, duration of intravenous antiemetic, and rehydration were not different. Intravenous rehydration with 5% dextrose-0.9% saline or 0.9% saline solution in women hospitalized for hyperemesis gravidarum produced similar outcomes. ISRCTN Register, www.controlled-trials.com/isrctn, ISRCTN65014409. I.

  14. Role of uterine artery doppler ultrasound in predicting preeclampsia primigravida

    International Nuclear Information System (INIS)

    Awan, F.; Ullah, H.

    2016-01-01

    Objective: To find the accuracy of uterine artery diastolic notching during the second trimester of pregnancy in predicting pre-eclampsia in primigravida patients. Study Design: Descriptive cross sectional study. Place and Duration of Study: Armed Forces Institute of Radiology and Imaging (AFIRI) Rawalpindi; six months duration from 30 Nov 2012 to 31 May 2013. Material and Methods: This study included 199 primigravida women with singleton pregnancy having diastolic notch in uterine arteries between 20 to 23 weeks of gestation. All patients were examined by both grey scale and doppler ultrasonography. Uterine arteries were evaluated with doppler near the point where they crossed the external iliac arteries. The patient was included in study if the presence of diastolic notch was demonstrated. Clinical follow up in gynae and obs department continued throughout the pregnancy to see if they developed preeclampsia. The data were recorded on a previously prepared proforma and analyzed with SPSS 21. Results: The accuracy of uterine artery doppler ultrasound in identifying women who later developed preeclampsia was 48.24 percent. The frequency of pre-eclampsia with bilateral notch was significantly high in the primigravid of younger age as compare to the primigravid of the older group (p=0.001). The difference in frequency of developing pre-eclampsia with bilateral notch when compared among 20 to 21 week gestational age and 22 to 23 weeks gestational age was statistically insignificant. Conclusion: Uterine artery diastolic notching between 20 and 23 weeks of gestation is an important risk factor for developing pre-eclampsia. This doppler parameter should, therefore, be included in the risk evaluation for gestational hypertension. (author)

  15. A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia.

    Science.gov (United States)

    Steele, Catriona M; Bayley, Mark T; Peladeau-Pigeon, Melanie; Nagy, Ahmed; Namasivayam, Ashwini M; Stokely, Shauna L; Wolkin, Talia

    2016-06-01

    The objective of this study was to compare the outcomes of two tongue resistance training protocols. One protocol ("tongue-pressure profile training") emphasized the pressure-timing patterns that are typically seen in healthy swallows by focusing on gradual pressure release and saliva swallowing tasks. The second protocol ("tongue-pressure strength and accuracy training") emphasized strength and accuracy in tongue-palate pressure generation and did not include swallowing tasks. A prospective, randomized, parallel allocation trial was conducted. Of 26 participants who were screened for eligibility, 14 received up to 24 sessions of treatment. Outcome measures of posterior tongue strength, oral bolus control, penetration-aspiration and vallecular residue were made based on videofluoroscopy analysis by blinded raters. Complete data were available for 11 participants. Significant improvements were seen in tongue strength and post-swallow vallecular residue with thin liquids, regardless of treatment condition. Stage transition duration (a measure of the duration of the bolus presence in the pharynx prior to swallow initiation, which had been chosen to capture impairments in oral bolus control) showed no significant differences. Similarly, significant improvements were not seen in median scores on the penetration-aspiration scale. This trial suggests that tongue strength can be improved with resistance training for individuals with tongue weakness following stroke. We conclude that improved penetration-aspiration does not necessarily accompany improvements in tongue strength; however, tongue-pressure resistance training does appear to be effective for reducing thin liquid vallecular residue.

  16. A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain

    Science.gov (United States)

    Cherkin, Daniel C.; Sherman, Karen J.; Avins, Andrew L.; Erro, Janet H.; Ichikawa, Laura; Barlow, William E.; Delaney, Kristin; Hawkes, Rene; Hamilton, Luisa; Pressman, Alice; Khalsa, Partap S.; Deyo, Richard A.

    2009-01-01

    Background Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. Methods 638 adults with chronic mechanical low back pain were randomized to: individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland Disability score, range: 0 to 23) and symptom bothersomeness (0 to 10 scale). Outcomes were assessed at baseline and after 8, 26 and 52 weeks. Results At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P0.05). Conclusions Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture’s purported mechanisms of action. It remains unclear whether acupuncture, or our simulated method of acupuncture, provide physiologically important stimulation or represent placebo or non-specific effects. PMID:19433697

  17. Garlic ameliorates histological changes in the uterine epithelium of lead induced mice

    International Nuclear Information System (INIS)

    Waseem, N.; Butt, S.A.; Hamid, S.

    2015-01-01

    To evaluate the protective role of garlic extract on the histology of the uterine epithelium exposed to lead acetate in an animal model. Study Design: Laboratory based randomized control trial. Place and Duration of Study: Department of Anatomy, Army Medical College in collaboration with National Institute of health from April to June 2013. Material and Methods: Thirty female BALBc mice were selected. Ten animals were placed in each group. Group A being the control was given normal diet. Group B was given lead acetate at a dose of 30 mg/kg/day. Group C was given lead acetate 30 mg/kg/day and garlic extract 500 mg/kg/day through oral gavage tube for 60 days. Animals were sacrificed and dissected at the end of 60 days. Right uterine horn was processed, embedded and stained for histological study. Height of epithelium was measured. It was taken from apical to basal end of the cells. Results: There was increase in height of the lining epithelium of uterus in group B, mean value 19.70 ± 4.81 meu m when compared to Group A, with mean value 13.25 ± 2.37 meu m. The height of the epithelium was relatively reduced in group C, with mean value 14.50 ± 2.30 meu m when compared with group B. In group C results were same as Group A. The p values were 0.001 when group A was compared to group B, 0.688 when group A was compared to group C and 0.005 when group B was compared to group C. Conclusion: The height of epithelium was markedly increased in lead acetate treated group which returned to normal when co treated with garlic extract. Hence garlic ameliorated the changes induced by lead. (author)

  18. Simultaneous uterine and urinary bladder rupture in an otherwise successful vaginal birth after cesarean delivery.

    Science.gov (United States)

    Ho, Szu-Ying; Chang, Shuenn-Dhy; Liang, Ching-Chung

    2010-12-01

    Uterine rupture is the primary concern when a patient chooses a trial of labor after a cesarean section. Bladder rupture accompanied by uterine rupture should be taken into consideration if gross hematuria occurs. We report the case of a patient with uterine rupture during a trial of labor after cesarean delivery. She had a normal course of labor and no classic signs of uterine rupture. However, gross hematuria was noted after repair of the episiotomy. The patient began to complain of progressive abdominal pain, gross hematuria and oliguria. Cystoscopy revealed a direct communication between the bladder and the uterus. When opening the bladder peritoneum, rupture sites over the anterior uterus and posterior wall of the bladder were noted. Following primary repair of both wounds, a Foley catheter was left in place for 12 days. The patient had achieved a full recovery by the 2-year follow-up examination. Bladder injury and uterine rupture can occur at any time during labor. Gross hematuria immediately after delivery is the most common presentation. Cystoscopy is a good tool to identify the severity of bladder injury. Copyright © 2010 Elsevier. Published by Elsevier B.V. All rights reserved.

  19. Simultaneous Uterine and Urinary Bladder Rupture in an Otherwise Successful Vaginal Birth After Cesarean Delivery

    Directory of Open Access Journals (Sweden)

    Szu-Ying Ho

    2010-12-01

    Full Text Available Uterine rupture is the primary concern when a patient chooses a trial of labor after a cesarean section. Bladder rupture accompanied by uterine rupture should be taken into consideration if gross hematuria occurs. We report the case of a patient with uterine rupture during a trial of labor after cesarean delivery. She had a normal course of labor and no classic signs of uterine rupture. However, gross hematuria was noted after repair of the episiotomy. The patient began to complain of progressive abdominal pain, gross hematuria and oliguria. Cystoscopy revealed a direct communication between the bladder and the uterus. When opening the bladder peritoneum, rupture sites over the anterior uterus and posterior wall of the bladder were noted. Following primary repair of both wounds, a Foley catheter was left in place for 12 days. The patient had achieved a full recovery by the 2-year follow-up examination. Bladder injury and uterine rupture can occur at any time during labor. Gross hematuria immediately after delivery is the most common presentation. Cystoscopy is a good tool to identify the severity of bladder injury.

  20. A randomised controlled trial comparing oxytocin and oxytocin + ergometrine for prevention of postpartum haemorrhage at caesarean section.

    Science.gov (United States)

    Koen, Sandy; Snyman, Leon Cornelius; Pattinson, Robert C; Makin, Jennifer A

    2016-03-07

    Globally 166 000 women die annually as a result of obstetric haemorrhage. More than 50% of these deaths occur in sub-Saharan Africa. Uterine atony is the commonest cause of severe postpartum haemorrhage (PPH). Bleeding at or after caesarean section (CS) is responsible for >30% of maternal deaths due to obstetric haemorrhage in South Africa (SA). To compare oxytocin alone with oxytocin + ergometrine in terms of primary prophylaxis for PPH at the time of CS. This was a double-blind randomised controlled interventional study comparing oxytocin with oxytocin + ergometrine administered during CS. Patients were randomised to receive oxytocin alone intravenously as a bolus or oxytocin + ergometrine intramuscularly, with the placebo being an injection of sterile water. The study population consisted of women undergoing CS at Kalafong Provincial Tertiary Hospital in Atteridgeville, Gauteng, SA. Five hundred and forty women were randomised and data for 416 women, of whom 214 received oxytocin and 202 oxytocin + ergometrine, were available for analysis. In the oxytocin group 19 women (8.9%) required blood transfusion, compared with seven (3.5%) in the oxytocin + ergometrine group (p=0.01; relative risk = 2.78; 95% confidence interval 1.21 - 6.4). There were no statistically significant differences in the mean estimated visual and mean calculated blood loss. The overall need for blood transfusion was significantly reduced by about two-thirds in women receiving the oxytocin + ergometrine combination. Consideration should be given to using oxytocin + ergometrine for prophylaxis of PPH at CS.

  1. Comparative randomised active drug controlled clinical trial of a herbal eye drop in computer vision syndrome.

    Science.gov (United States)

    Chatterjee, Pranab Kr; Bairagi, Debasis; Roy, Sudipta; Majumder, Nilay Kr; Paul, Ratish Ch; Bagchi, Sunil Ch

    2005-07-01

    A comparative double-blind placebo-controlled clinical trial of a herbal eye drop (itone) was conducted to find out its efficacy and safety in 120 patients with computer vision syndrome. Patients using computers for more than 3 hours continuously per day having symptoms of watering, redness, asthenia, irritation, foreign body sensation and signs of conjunctival hyperaemia, corneal filaments and mucus were studied. One hundred and twenty patients were randomly given either placebo, tears substitute (tears plus) or itone in identical vials with specific code number and were instructed to put one drop four times daily for 6 weeks. Subjective and objective assessments were done at bi-weekly intervals. In computer vision syndrome both subjective and objective improvements were noticed with itone drops. Itone drop was found significantly better than placebo (pcomputer vision syndrome.

  2. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

    DEFF Research Database (Denmark)

    Rasmussen, Benjamin S B; Froekjaer, Johnny; Bjerregaard, Mads R

    2015-01-01

    OBJECTIVE: The role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. RESEARCH DESIGN AND METHODS: Of the 736 screened...... individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient's own home and one consultation at the outpatient clinic. Standard practice consisted...... monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical...

  3. Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts

    Science.gov (United States)

    Pagnoux, Christian; Carette, Simon; Khalidi, Nader A.; Walsh, Michael; Hiemstra, Thomas F.; Cuthbertson, David; Langford, Carol; Hoffman, Gary S.; Koening, Curry L.; Monach, Paul A.; Moreland, Larry; Mouthon, Luc; Seo, Phil; Specks, Ulrich; Ytterberg, Steven; Westman, Kerstin; Hoglund, Peter; Harper, Lorraine; Flossmann, Oliver; Luqmani, Raashid; Savage, Caroline; Rasmussen, Niels; de Groot, Kirstin; Tesar, Vladimir; Jayne, David; Merkel, Pater A.; Guillevin, Loic

    2015-01-01

    Objective To analyse the differences between patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) entered into randomised clinical trials (RCTs) and those followed in large observational cohorts. Methods The main characteristics and outcomes of patients with generalised and/or severe GPA or MPA with a five-factor score ≥1 enrolled in the French Vasculitis Study Group (FVSG) or the US-Canadian-based Vasculitis Clinical Research Consortium cohorts were compared to those enrolled in one of 2 FVSG clinical RCTs (WEG91, WEGENT) or 3 European Vasculitis Society clinical trials (CYCLOPS, CYCAZAREM, IMPROVE). Results 657 patients (65.3% with GPA) in RCTs were compared to 437 in cohorts (90.6% with GPA). RCT patients were older at diagnosis than the cohort patients (56.6±13.9 vs. 46.8±17.3 years), had higher Birmingham vasculitis activity score (19.5±9.1 vs. 16.9±7.4), and more frequent kidney disease (84.0% vs. 54.9%) but fewer ear, nose, and throat symptoms (56.8% vs. 72.2%). At 56 months post-diagnosis, mortality and relapse rates, adjusted for age and renal function, were higher for patients with GPA in RCTs vs. cohorts (10.7% vs. 2.5% [p=0.001] and 22.5% vs. 15.6% [p=0.03], respectively) but similar for patients with MPA (6.2% vs. 6.6% [p=0.92] and 16.6% vs. 10.1% [p=0.39], respectively). Conclusion Patients with GPA or MPA in RCTs and those in observational cohorts show important differences that should be remembered when interpreting results based on these study populations. PMID:26016754

  4. Economic evaluation of the randomized European Achalasia trial comparing pneumodilation with Laparoscopic Heller myotomy.

    Science.gov (United States)

    Moonen, A; Busch, O; Costantini, M; Finotti, E; Tack, J; Salvador, R; Boeckxstaens, G; Zaninotto, G

    2017-11-01

    A recent multicenter randomized trial in achalasia patients has shown that pneumatic dilation resulted in equivalent relief of symptoms compared to laparoscopic Heller myotomy. Additionally, the cost of each treatment should be also taken in consideration. Therefore, the aim of the present study was to perform an economic analysis of the European achalasia trial. Patients with newly diagnosed achalasia were enrolled from to 2003 to 2008 in 14 centers in five European countries and were randomly assigned to either pneumatic dilation (PD) or laparoscopic Heller (LHM). The economic analysis was performed in the three centers in three different countries where most patients were enrolled (Amsterdam [NL], Leuven, [B] and Padova [I]) and then applied to all patients included in the study. The total raw costs of the two treatments per patient include the initial costs, the costs of complications, and the costs of retreatments. Two hundred and one patients, 107 (57 males and 50 females, mean age 46 CI: 43-49 years) were randomized to LHM and 94 (59 males and 34 females, mean age 46 CI 43-50 years) to PD. The total cost of PD per patient was quite comparable in the three different centers; €3397 in Padova, €3259 in Amsterdam and €3792 in Leuven. For LHM, the total costs per patient were highest in Amsterdam: €4488 in Padova, €6720 in Amsterdam, and €5856 in Leuven. In conclusion, the strategy of treating achalasia starting with PD appears the most economic approach, independent of the health system. © 2017 John Wiley & Sons Ltd.

  5. Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3.

    Science.gov (United States)

    Takács, István; Tóth, Béla E; Szekeres, László; Szabó, Boglárka; Bakos, Bence; Lakatos, Péter

    2017-01-01

    The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3 -not previously investigated-will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D 3 . The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D 3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D 3 provide equal efficacy and safety profiles.

  6. Internet treatment for generalized anxiety disorder: a randomized controlled trial comparing clinician vs. technician assistance.

    Science.gov (United States)

    Robinson, Emma; Titov, Nickolai; Andrews, Gavin; McIntyre, Karen; Schwencke, Genevieve; Solley, Karen

    2010-06-03

    Internet-based cognitive behavioural therapy (iCBT) for generalized anxiety disorder (GAD) has been shown to be effective when guided by a clinician. The present study sought to replicate this finding, and determine whether support from a technician is as effective as guidance from a clinician. Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program and 150 participants with GAD were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for GAD comprising six online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 10 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Penn State Worry Questionnaire (PSWQ) and the Generalized Anxiety Disorder-7 Item (GAD-7). Completion rates were high, and both treatment groups reduced scores on the PSWQ (ptechnician-assisted groups, respectively, and on the GAD-7 were 1.55 and 1.73, respectively. At 3 month follow-up participants in both treatment groups had sustained the gains made at post-treatment. Participants in the clinician-assisted group had made further gains on the PSWQ. Approximately 81 minutes of clinician time and 75 minutes of technician time were required per participant during the 10 week treatment program. Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment/control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and acceptability of technician-assisted iCBT programs for GAD. This form of treatment has potential to increase the

  7. The effects of nocturnal compared with conventional hemodialysis on mineral metabolism: A randomized-controlled trial.

    Science.gov (United States)

    Walsh, Michael; Manns, Braden J; Klarenbach, Scott; Tonelli, Marcello; Hemmelgarn, Brenda; Culleton, Bruce

    2010-04-01

    Hyperphosphatemia is common among patients receiving dialysis and is associated with increased mortality. Nocturnal hemodialysis (NHD) is a long, slow dialytic modality that may improve hyperphosphatemia and disorders of mineral metabolism. We performed a randomized-controlled trial of NHD compared with conventional hemodialysis (CvHD); in this paper, we report detailed results of mineral metabolism outcomes. Prevalent patients were randomized to receive NHD 5 to 6 nights per week for 6to 10 hours per night or to continue CvHD thrice weekly for 6 months. Oral phosphate binders and vitamin D analogs were adjusted to maintain phosphate, calcium and parathyroid hormone (PTH) levels within recommended targets. Compared with CvHD patients, patients in the NHD group had a significant decrease in serum phosphate over the course of the study (0.49 mmol/L, 95% confidence interval 0.24-0.74; P=0.002) despite a significant reduction in the use of phosphate binders. Sixty-one percent of patients in the NHD group compared with 20% in the CvHD group had a decline in intact PTH (P=0.003). Nocturnal hemodialysis lowers serum phosphate, calcium-phosphate product and requirement for phosphate binders. The effects of NHD on PTH are variable. The impact of these changes on long-term cardiovascular and bone-related outcomes requires further investigation.

  8. Value and importance of intracavitary therapy in uterine cervix carcinoma

    International Nuclear Information System (INIS)

    Frischkorn, R.

    1986-01-01

    The guiding topic of this report was 'the value and importance of intracavitary therapy in uterine cervix carcinoma'. This implies first of all the task to assess the importance of contact therapy within the scope of all therapeutic measures taken in case of uterine cervix carcinoma. Furthermore it was necessary to compare the importance of the different methods of contact therapy: conventional radium therapy as well as low dose rate and high dose rate afterloading techniques. As to surgical intervention, it is clear that only favorable stages can be taken into consideration for this treatment. It is shown by means of data taken from the Annual Report, Vol. 18, that a considerable number of patients with uterine cervix carcinoma I are irradiated even in hospitals whose field of activity lies preponderantly in surgery, and that by far most of the patients cured from uterine cervix cancer owe their recovery to contact therapy. The consideration of contact therapy methods show clearly that radium should no longer be used in clinical practice. Psychological doubts often hinder the decision if long-term or short-term afterloading therapy is to be applied. It is therefore shown that the very different forms of radium therapy with their chronological and spatial dose distribution were due to the characteristics of radium (e.g. little specific activity) or to other compelling features and that they were not based on radiobiological aspects. The radium dose values obtained by empirical research and the resulting spatial and chronological dose distribution are therefore not imperative. So it is not inevitable to choose the low dose rate afterloading method. On the contrary, the high dose rate technique with an adequate fractionation is very probably the method of choice. To sum up it can be said that contact therapy is still the most important therapeutic method in uterine cervix cancer. (orig.) [de

  9. Protocol for the saMS trial (supportive adjustment for multiple sclerosis: a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis

    Directory of Open Access Journals (Sweden)

    McCrone Paul

    2009-08-01

    Full Text Available Abstract Background Multiple Sclerosis (MS is an incurable, chronic, potentially progressive and unpredictable disease of the central nervous system. The disease produces a range of unpleasant and debilitating symptoms, which can have a profound impact including disrupting activities of daily living, employment, income, relationships, social and leisure activities, and life goals. Adjusting to the illness is therefore particularly challenging. This trial tests the effectiveness of a Cognitive Behavioural intervention compared to Supportive Listening to assist adjustment in the early stages of MS. Methods/Design This is a two arm randomized multi-centre parallel group controlled trial. 122 consenting participants who meet eligibility criteria will be randomly allocated to receive either Cognitive Behavioral Therapy or Supportive Listening. Eight one hour sessions of therapy (delivered over a period of 10 weeks will be delivered by general nurses trained in both treatments. Self-report questionnaire data will be collected at baseline (0 weeks, mid-therapy (week 5 of therapy, post-therapy (15 weeks and at six months (26 weeks and twelve months (52 weeks follow-up. Primary outcomes are distress and MS-related social and role impairment at twelve month follow-up. Analysis will also consider predictors and mechanisms of change during therapy. In-depth interviews to examine participants' experiences of the interventions will be conducted with a purposively sampled sub-set of the trial participants. An economic analysis will also take place. Discussion This trial is distinctive in its aims in that it aids adjustment to MS in a broad sense. It is not a treatment specifically for depression. Use of nurses as therapists makes the interventions potentially viable in terms of being rolled out in the NHS. The trial benefits from incorporating patient input in the development and evaluation stages. The trial will provide important information about the

  10. Evaluation of Mayer-Rokitansky-Kuester-Hauser syndrome with magnetic resonance imaging: Three patterns of uterine remnants and related anatomical features and clinical settings

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Yue; Lu, Jingjing; Jiang, Bo; Feng, Feng; Jin, Zhengyu [Peking Union Medical College, Chinese Academy of Medical Sciences, Department of Radiology, Peking Union Medical College Hospital, Beijing (China); Zhu, Lan; Sun, Zhijing [Chinese Academy of Medical Sciences, Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Peking Union Medical College, Bejing (China)

    2017-12-15

    To characterize the anatomical features and clinical settings of Mayer-Rokitansky-Kuester-Hauser (MRKH) syndrome and correlate them with patterns of uterine involvement. Pelvic magnetic resonance images and medical records of 92 MRKH patients were retrospectively reviewed. Patients were subgrouped by uterine morphology: uterine agenesis, unilateral rudimentary uterus and bilateral rudimentary uteri. Uterine volume, presence of endometrium, location of ovary, endometriosis and pelvic pain were compared among groups. The mean uterine volume was 33.5 ml (17.5-90.0 ml) for unilateral uterine remnants, and 16.1 ml (3.5-21.5 ml) for bilateral uterine rudiments (p<0.01). The incidence of presence of endometrium (100% vs. 22%, p<0.001), haematometra (56% vs. 3%, p<0.001) and ovarian endometriosis (22% vs. 3%, p<0.01) was significantly increased in the group of unilateral rudimentary uteri as compared with the group of bilateral uterine remnants. Thirty-one patients (38%) showed ectopic ovaries. Pelvic pain was more common in individuals with unilateral rudimentary uterus than those who had no (56% vs. 5%, p<0.01) or bilateral uterine remnants (56% vs. 14%, p<0.05). MRKH patients with different patterns of uterine involvement may have differentiated anatomical features and clinical settings. (orig.)

  11. A prospective randomised trial comparing mesh types and fixation in totally extraperitoneal inguinal hernia repairs.

    Science.gov (United States)

    Cristaudo, Adam; Nayak, Arun; Martin, Sarah; Adib, Reza; Martin, Ian

    2015-05-01

    The totally extraperitoneal (TEP) approach for surgical repair of inguinal hernias has emerged as a popular technique. We conducted a prospective randomised trial to compare patient comfort scores using different mesh types and fixation using this technique. Over a 14 month period, 146 patients underwent 232 TEP inguinal hernia repairs. We compared the comfort scores of patients who underwent these procedures using different types of mesh and fixation. A non-absorbable 15 × 10 cm anatomical mesh fixed with absorbable tacks (Control group) was compared with either a non-absorbable 15 × 10 cm folding slit mesh with absorbable tacks (Group 2), a partially-absorbable 15 × 10 cm mesh with absorbable tacks (Group 3) or a non-absorbable 15 × 10 cm anatomical mesh fixed with 2 ml fibrin sealant (Group 4). Outcomes were compared at 1, 2, 4 and 12 weeks using the Carolina Comfort Scale (CCS) scores. At 1, 2, 4 and 12 weeks, the median global CCS scores were low for all treatment groups. Statistically significant differences were seen only for median CCS scores and subscores with the use of partially-absorbable mesh with absorbable tacks (Group 3) at weeks 2 and 4. However, these were no longer significant at week 12. In this study, the TEP inguinal hernia repair with minimal fixation results in low CCS scores. There were no statistical differences in CCS scores when comparing types of mesh, configuration of the mesh or fixation methods. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  12. Technique and methods in uterine leiomyoma embolization

    International Nuclear Information System (INIS)

    Helmberger, T.K.; Jakobs, T.F.; Reiser, M.F.

    2003-01-01

    Uterine leiomyomas are the most common benign tumors of the female urogenital tract. Beside the classic surgical treatment options the minimal-invasive embolization therapy of the leiomyomas increasingly gains importance world-wide. Technique, complications, and results of uterine leiomyoma embolization will be presented. After careful evaluation of indications for embolization the procedure is mostly performed under conscious sedation. A single-sided femoral access route together with cross-over technique generally allows for a flow-directed embolization via both uterine arteries. After embolizing the vessels supplying the tumor, the uterine arteries should be still patent. The success rate of embolization of uterine leiomyomas ranges between 85 and 100%, whereas a reduction in size of the tumors in 42 to 83% and a relief of symptoms in up to 96% can be achieved. The total complication rate is about 10% with mainly ''minor complications''. Worldwide only three deaths following embolization of uterine leiomyomas were reported. The high technical and clinical success rate together with a low complication rate make the embolization of uterine leiomyomas a minimally-invasive alternative to the classic treatment. As long term results are not available indication to embolization of uterine leiomyomas must be carefully established in consensus with gynecologists. (orig.) [de

  13. Uterine rupture without previous caesarean delivery

    DEFF Research Database (Denmark)

    Thisted, Dorthe L. A.; H. Mortensen, Laust; Krebs, Lone

    2015-01-01

    to uterine rupture when adjusted for parity, epidural analgesia and augmentation by oxytocin. CONCLUSION: Although uterine rupture is rare, its association with epidural analgesia and augmentation of labour with oxytocin in multipara should be considered. Thus, vigilance should be exercised when labour...

  14. Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-01-01

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

  15. Comparative costs and activity from a sample of UK clinical trials units.

    Science.gov (United States)

    Hind, Daniel; Reeves, Barnaby C; Bathers, Sarah; Bray, Christopher; Corkhill, Andrea; Hayward, Christopher; Harper, Lynda; Napp, Vicky; Norrie, John; Speed, Chris; Tremain, Liz; Keat, Nicola; Bradburn, Mike

    2017-05-02

    The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities. Representatives of ten CTUs and two grant-awarding bodies pooled their experiences in discussions over 1.5 years. Five of the CTUs provided estimates of, and written justification for, costs associated with CTU activities required to implement an identical protocol. The protocol described a 5.5-year, nonpharmacological randomized controlled trial (RCT) conducted at 20 centres. Direct and indirect costs, the number of full time equivalents (FTEs) and the FTEs attracting overheads were compared and qualitative methods (unstructured interviews and thematic analysis) were used to interpret the results. Four members of the group (funding-body representatives or award panel members) reviewed the justification statements for transparency and information content. Separately, 163 activities common to trials were assigned to roles used by nine CTUs; the consistency of role delineation was assessed by Cohen's κ. Median full economic cost of CTU activities was £769,637 (range: £661,112 to £1,383,323). Indirect costs varied considerably, accounting for between 15% and 59% (median 35%) of the full economic cost of the grant. Excluding one CTU, which used external statisticians, the total number of FTEs ranged from 2.0 to 3.0; total FTEs attracting overheads ranged from 0.3 to 2.0. Variation in directly incurred staff costs depended on whether CTUs: supported particular roles from core funding rather than grants; opted not to cost certain activities into the grant; assigned clerical or data management tasks to research or administrative staff; employed extensive on-site monitoring strategies (also the main source of variation in non-staff costs). Funders preferred written justifications of costs that described both FTEs and indicative tasks for funded roles, with itemised non-staff costs. Consistency in role delineation was fair (κ

  16. Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

    Science.gov (United States)

    Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

    2016-05-01

    ). This article reports on the complications/adverse events that were prospectively identified up to 2 years postoperatively, in a defined patient population participating in a large double-blind randomized clinical trial comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture.

  17. Prescription patterns of Chinese herbal products for patients with uterine fibroid in Taiwan: A nationwide population-based study.

    Science.gov (United States)

    Yen, Hung-Rong; Chen, Ying-Yu; Huang, Tzu-Ping; Chang, Tung-Ti; Tsao, Jung-Ying; Chen, Bor-Chyuan; Sun, Mao-Feng

    2015-08-02

    Uterine fibroid (myoma) is one of the most common diseases in women. Although there are several studies on the efficacy of Chinese herbs, there is a lack of large-scale survey on the use of traditional Chinese medicine (TCM) for the treatment of uterine fibroid. This study aimed to investigate the utilization of Chinese herbal products for patients with uterine fibroid, prescribed by licensed TCM doctors in Taiwan. A random sample comprised of one million individuals with newly diagnosed uterine fibroid between 2002 and 2010 from the Taiwanese National Health Insurance Research Database was analyzed. Demographic characteristics, TCM usage, the frequency as well as average daily dose of Chinese herbal formulas and the single herbs prescribed for patients with uterine fibroid, were analyzed. Overall, 35,786 newly diagnosed subjects with uterine fibroid were included. Majority of these patients (87.1%; n=31,161) had visited TCM clinics. Among them, 61.8% of their visits used Chinese herbal remedies. Patients less than 45 years of age tended to use TCM more frequently than elder patients. Gui-Zhi-Fu-Ling-Wan (Cinnamon Twig and Poria Pill) was the most frequently prescribed Chinese herbal formula, while San-Leng (Rhizoma Sparganii) was the most commonly prescribed single herb. Our study identified the characteristics and prescription patterns of TCM for patients with uterine fibroid in Taiwan. Further basic mechanistic studies and clinical trials are needed to confirm the therapeutic effects and mechanisms. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  18. Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy: a randomized controlled trial.

    Science.gov (United States)

    Culligan, Patrick J; Salamon, Charbel; Priestley, Jennifer L; Shariati, Amir

    2013-01-01

    To compare the surgical outcomes 12 months after laparoscopic sacrocolpopexy performed with porcine dermis and the current gold standard of polypropylene mesh. Patients scheduled for laparoscopic sacrocolpopexy were eligible for this randomized controlled trial. Both our clinical research nurse and the patients were blinded as to which material was used. Our primary end point was objective anatomic cure defined as no pelvic organ prolapse quantification (POP-Q) points Stage 2 or greater at any postoperative interval. Our sample size calculation called for 57 patients in each group to achieve 90% power to detect a 23% difference in objective anatomic cure at 12 months (α=0.05). Our secondary end point was clinical cure. Any patient with a POP-Q point greater than zero, or Point C less than or equal to -5, or any complaints of prolapse symptoms whatsoever on Pelvic Floor Distress Inventory-20 or Pelvic Floor Impact Questionnaire, Short Form 7, or reoperation for prolapse were considered "clinical failures"; the rest were "clinical cures." Statistical comparisons were performed using the χ or independent samples t test as appropriate. As expected, there were no preoperative differences between the porcine (n=57) and mesh (n=58) groups. The 12-month objective anatomic cure rates for the porcine and mesh groups were 80.7% and 86.2%, respectively (P=.24), and the "clinical cure" rates for the porcine and mesh groups were 84.2% and 89.7%, respectively (P=.96). Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire, Short Form 7 score improvements were significant for both groups with no differences found between groups. There were no major operative complications. There were similar outcomes in subjective or objective results 12 months after laparoscopic sacrocolpopexy performed with either porcine dermis or polypropylene mesh. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00564083. I.

  19. Polyarteritis nodosa with uterine involvement

    Directory of Open Access Journals (Sweden)

    Chihiro Hirai

    2012-12-01

    Full Text Available Polyarteritis nodosa (PAN is characterized by multisystem necrotizing vasculitis, primarily affecting small-to-medium-sized muscular arteries, and it is typically found in middle-aged men. PAN is rarely found in the female genital tract (including the uterus, and imaging of the uterus with PAN has not previously been reported. Reported is a case of a 78-year-old patient with uterus enlargement who was diagnosed with PAN through clinical findings and images. Computed tomography and magnetic resonance imaging findings of a uterus affected by PAN are presented and reviewed, and potential characteristic findings of the uterine with PAN are discussed.

  20. Polyarteritis nodosa with uterine involvement

    International Nuclear Information System (INIS)

    Hirai, Chihiro; Koike, Shigeomi; Hirano, Motoharu; Nishimura, Junichi; Akashita, Shiho; Ohkoshi, Takahumi; Katsumata, Yasushi

    2012-01-01

    Polyarteritis nodosa (PAN) is characterized by multisystem necrotizing vasculitis, primarily affecting small-to-medium-sized muscular arteries, and it is typically found in middle-aged men. PAN is rarely found in the female genital tract (including the uterus), and imaging of the uterus with PAN has not previously been reported. Reported is a case of a 78-year-old patient with uterus enlargement who was diagnosed with PAN through clinical findings and images. Computed tomography and magnetic resonance imaging findings of a uterus affected by PAN are presented and reviewed, and potential characteristic findings of the uterine with PAN are discussed

  1. Comparative efficacy of simultaneous versus sequential multiple health behavior change interventions among adults: A systematic review of randomised trials.

    Science.gov (United States)

    James, Erica; Freund, Megan; Booth, Angela; Duncan, Mitch J; Johnson, Natalie; Short, Camille E; Wolfenden, Luke; Stacey, Fiona G; Kay-Lambkin, Frances; Vandelanotte, Corneel

    2016-08-01

    Growing evidence points to the benefits of addressing multiple health behaviors rather than single behaviors. This review evaluates the relative effectiveness of simultaneous and sequentially delivered multiple health behavior change (MHBC) interventions. Secondary aims were to identify: a) the most effective spacing of sequentially delivered components; b) differences in efficacy of MHBC interventions for adoption/cessation behaviors and lifestyle/addictive behaviors, and; c) differences in trial retention between simultaneously and sequentially delivered interventions. MHBC intervention trials published up to October 2015 were identified through a systematic search. Eligible trials were randomised controlled trials that directly compared simultaneous and sequential delivery of a MHBC intervention. A narrative synthesis was undertaken. Six trials met the inclusion criteria and across these trials the behaviors targeted were smoking, diet, physical activity, and alcohol consumption. Three trials reported a difference in intervention effect between a sequential and simultaneous approach in at least one behavioral outcome. Of these, two trials favoured a sequential approach on smoking. One trial favoured a simultaneous approach on fat intake. There was no difference in retention between sequential and simultaneous approaches. There is limited evidence regarding the relative effectiveness of sequential and simultaneous approaches. Given only three of the six trials observed a difference in intervention effectiveness for one health behavior outcome, and the relatively consistent finding that the sequential and simultaneous approaches were more effective than a usual/minimal care control condition, it appears that both approaches should be considered equally efficacious. PROSPERO registration number: CRD42015027876. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain.

    Science.gov (United States)

    Girandola, Robert N; Srivastava, Shalini; Loullis, Costas C

    2016-04-06

    To study the effect of Lanconone® (1000 mg) on acute pain on exertion as compared to the standard of care, Ibuprofen (400 mg). The study recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Subjects with Pain Visual Analogue Scale of more than 40 mm were included. Uphill walking was provided as the stressor using Naughton's protocol on a treadmill. The subjects walked for 10 minutes continuously followed by a rest period and baseline pain score for index knee joint was recorded. Subjects were administered a single dose of Lanconone® (1000 mg)/Ibuprofen (400 mg). Thereafter the same stressor was provided at 0.5, 1, 2, 3, 4, and 6 hours, subsequently, pain scores were recorded on a visual analogue scale. Double stopwatch method was used to evaluate the onset of pain relief and time taken to meaningful pain relief. Both Lanconone® and Ibuprofen showed the first perceived pain relief at 65.31 ± 35.57 mins as compared to 60.82 ± 32.56 mins respectively. The mean time taken to experience meaningful pain relief in Lanconone® group was 196.59 ± 70.85 mins compared to 167.13 ± 71.41 mins amongst Ibuprofen group. The meaningful pain relief continued for 6 hours. The current study successfully demonstrated rapid pain-relieving potential of Lanconone® which was comparable to Ibuprofen. No adverse event related to the interventions was reported in the study. Clinical trials.gov NCT02417506 . 21 January 2015.

  3. A randomized controlled trial comparing EMDR and CBT for obsessive-compulsive disorder.

    Science.gov (United States)

    Marsden, Zoe; Lovell, Karina; Blore, David; Ali, Shehzad; Delgadillo, Jaime

    2018-01-01

    This study aimed to evaluate eye movement desensitization and reprocessing (EMDR) as a treatment for obsessive-compulsive disorder (OCD), by comparison to cognitive behavioural therapy (CBT) based on exposure and response prevention. This was a pragmatic, feasibility randomized controlled trial in which 55 participants with OCD were randomized to EMDR (n = 29) or CBT (n = 26). The Yale-Brown obsessive-compulsive scale was completed at baseline, after treatment and at 6 months follow-up. Treatment completion and response rates were compared using chi-square tests. Effect size was examined using Cohen's d and multilevel modelling. Overall, 61.8% completed treatment and 30.2% attained reliable and clinically significant improvement in OCD symptoms, with no significant differences between groups (p > .05). There were no significant differences between groups in Yale-Brown obsessive-compulsive scale severity post-treatment (d = -0.24, p = .38) or at 6 months follow-up (d = -0.03, p = .90). EMDR and CBT had comparable completion rates and clinical outcomes. Copyright © 2017 John Wiley & Sons, Ltd.

  4. Comparing the effects of Calendula officinalis and clotrimazole on vaginal Candidiasis: A randomized controlled trial.

    Science.gov (United States)

    Saffari, Elnaz; Mohammad-Alizadeh-Charandabi, Sakineh; Adibpour, Mohammad; Mirghafourvand, Mojgan; Javadzadeh, Yousef

    2017-01-01

    This triple-blind trial examined the effects of Calendula officinalis vaginal cream on the treatment of vaginal Candidiasis (primary outcome) and sexual function (secondary outcome). Married women aged 18-45 years with vaginal Candidiasis (n = 150) were recruited from April to October 2014 and randomized into Calendula and clotrimazole groups, using 5-g vaginal cream every night for seven nights. Clinical and laboratory assessments were conducted at 10-15 and 30-35 days after intervention and the female sexual function index was assessed at 30-35 days. Six women were lost to follow-up. The frequency of testing negative for Candidiasis in the Calendula group was significantly lower at the first (49% vs. 74%; odds ratio (OR) 0.32; 95% confidence interval (CI) 0.16-0.67) but higher at the second (77% vs. 34%; OR 3.1; 95% CI 1.5-6.2) follow-up compared to the clotrimazole group. The frequency of most signs and symptoms were almost equal in the two groups at the first follow-up, but were significantly lower in the Calendula group at the second follow-up. Sexual function had almost equal significant improvement in both groups. Calendula vaginal cream appears to have been effective in the treatment of vaginal Candidiasis and to have a delayed but greater long-term effect compared to clotrimazole.

  5. Metformin compared with insulin in the management of gestational diabetes mellitus: a randomized clinical trial.

    Science.gov (United States)

    Niromanesh, Shirin; Alavi, Azin; Sharbaf, Fatemeh Rahimi; Amjadi, Nooshin; Moosavi, Sanaz; Akbari, Soheila

    2012-12-01

    To evaluate the effect of metformin and insulin in glycemic control and compare pregnancy outcome in women with gestational diabetes mellitus (GDM). This randomized controlled trial was conducted in GDM women with singleton pregnancy and gestational age between 20 and 34 weeks who did not achieve glycemic control on diet were assigned randomly to receive either metformin (n=80) or insulin (n=80). The primary outcomes were maternal glycemic control and birth weight. The secondary outcomes were neonatal and obstetric complications. Two groups were comparable regarding the maternal characteristics. Two groups were similar in mean FBS (P=0.68) and postprandial measurements (P=0.87) throughout GDM treatment. The neonates of metformin group had less rate of birth weight centile >90 than insulin group (RR: 0.5, 95% CI: 0.3-0.9, P=0.012). Maternal weight gain was reduced in the metformin group (P0.05). In metformin group 14% of women needed to supplemental insulin to achieve euglycemia. Metformin is an effective and safe alternative treatment to insulin for women with GDM. This study does not show significant risk of maternal or neonatal adverse outcome with the use of metformin. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  6. Microallelotyping defines novel regions of loss of heterozygosity in uterine leiomyomas

    DEFF Research Database (Denmark)

    Canevari, Renata de Azevedo; Pontes, Anaglória; Rogatto, Silvia Regina

    2005-01-01

    Uterine leiomyomas are extremely common, benign, smooth muscle tumors that represent a significant public health problem. Although there have been few molecular studies of uterine leiomyomas, most of them have reported a very low frequency of loss of heterozygosity (LOH) in different regions...... of the genome. The detection of LOH has been used to identify genomic regions that harbor tumor suppressor genes and to characterize different tumor types. We have used a set of 15 microsatellite polymorphism markers to examine the frequency of allele loss in a panel of 64 human uterine leiomyomas matched...... to normal DNAs. The markers were chosen from regions involved in losses identified by comparative genomic hybridization in a subset of uterine leiomyomas described in a previous report. DNA from tumors and normal tissue was amplified by the polymerase chain reaction and subsequently analyzed using an ABI...

  7. The study of the value of applying the special functions of DSA during uterine artery embolization

    International Nuclear Information System (INIS)

    Wang Ting; Zhao Zhenhua; Lv Weigong

    2007-01-01

    Objective: To study the value of applying the special functions of DSA during uterine artery embolization. Methods: 122 cases were performed uterine artery embolization, including 67 cases with traditional operation and 55 cases with applying the special functions of DSA: rotary DSA angiography, the best work position and road map technology. We recorded the correlative operative indices to compare and analyse the mean exposure time, the mean operative time, the mean dosage of contrast medium, the probability of vasospasm and injury of blood vessel during operation. Results: The mean exposure time, mean operative time and the mean dosage of contrast medium were reduced with the special functions of DSA during uterine artery embolization. There is significant difference between traditional operation and the operation applying the special functions of DSA (P<0.01). Conclusion: Applying the special functions of DSA during uterine artery embolization can reduce the operative time, operative risk and economic burden. (authors)

  8. Subcutaneous Injection of Adalimumab Trial compared with Control (SCIATiC): a randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.

    Science.gov (United States)

    Williams, Nefyn H; Jenkins, Alison; Goulden, Nia; Hoare, Zoe; Hughes, Dyfrig A; Wood, Eifiona; Foster, Nadine E; Walsh, David A; Carnes, Dawn; Sparkes, Valerie; Hay, Elaine M; Isaacs, John; Konstantinou, Kika; Morrissey, Dylan; Karppinen, Jaro; Genevay, Stephane; Wilkinson, Clare

    2017-10-01

    Biological treatments such as adalimumab (Humira ® ; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica. Pragmatic, parallel-group, randomised controlled trial with blinded participants and clinicians, and an outcome assessment and statistical analysis with concurrent economic evaluation and internal pilot. Participants were referred from primary care and musculoskeletal services to outpatient physiotherapy clinics. Adults with persistent symptoms of sciatica of 1-6 months' duration and with moderate to high levels of disability. Eligibility was assessed by research physiotherapists according to clinical criteria for diagnosing sciatica. After a second eligibility check, trial participants were randomised to receive two doses of adalimumab (80 mg and then 40 mg 2 weeks later) or saline injections. Both groups were referred for a course of physiotherapy. Outcomes were measured at the start, and after 6 weeks' and 6 months' follow-up. The main outcome measure was the Oswestry Disability Index (ODI). Other outcomes: leg pain version of the Roland-Morris Disability Questionnaire, Sciatica Bothersomeness Index, EuroQol-5 Dimensions, 5-level version, Hospital Anxiety and Depression Scale, resource use, risk of persistent disabling pain, pain trajectory based on a single question, Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia and adverse effects. To detect an effect size of 0.4 with 90% power, a 5% significance level for a two-tailed t -test and 80% retention

  9. A consensus-based guideline defining clinical target volume for primary disease in external beam radiotherapy for intact uterine cervical cancer

    International Nuclear Information System (INIS)

    Toita, Takafumi; Ohno, Tatsuya; Kaneyasu, Yuko

    2011-01-01

    The objective of this study was to develop a consensus-based guideline to define clinical target volume for primary disease (clinical target volume primary) in external beam radiotherapy for intact uterine cervical cancer. The working subgroup of the Japan Clinical Oncology Group (JCOG) Radiation Therapy Study Group began developing a guideline for primary clinical target volume in November 2009. The group consisted of 10 radiation oncologists and 2 gynecologic oncologists. The process started with comparing the contouring on computed tomographic images of actual cervical cancer cases among the members. This was followed by a comprehensive literature review that included primary research articles and textbooks as well as information on surgical procedures. Extensive discussion occurred in face-to-face meetings (three occasions) and frequent e-mail communications until a consensus was reached. The working subgroup reached a consensus on the definition for the clinical target volume primary. The clinical target volume primary consists of the gross tumor volume, uterine cervix, uterine corpus, parametrium, vagina and ovaries. Definitions for these component structures were determined. Anatomical boundaries in all directions were defined for the parametrium. Examples delineating these boundaries were prepared for the posterior border of the parametrium for various clinical situations (id est (i.e.) central tumor bulk, degree of parametrial involvement). A consensus-based guideline defining the clinical target volume primary was developed for external beam radiotherapy for intact uterine cervical cancer. This guideline will serve as a template for radiotherapy protocols in future clinical trials. It may also be used in actual clinical practice in the setting of highly precise external beam radiotherapy, including intensity-modulated radiotherapy. (author)

  10. Risk factors for low vision related functioning in the Mycotic Ulcer Treatment Trial: a randomised trial comparing natamycin with voriconazole.

    Science.gov (United States)

    Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; Porco, Travis C; McLeod, Stephen D; Acharya, Nisha R; Keenan, Jeremy D; Lietman, Thomas M

    2016-07-01

    The Mycotic Ulcer Treatment Trial I (MUTT I) was a double-masked, multicentre, randomised controlled trial, which found that topical natamycin is superior to voriconazole for the treatment of filamentous fungal corneal ulcers. In this study, we determine risk factors for low vision-related quality of life in patients with fungal keratitis. The Indian visual function questionnaire (IND-VFQ) was administered to MUTT I study participants at 3 months. Associations between patient and ulcer characteristics and IND-VFQ subscale score were assessed using generalised estimating equations. 323 patients were enrolled in the trial, and 292 (90.4%) completed the IND-VFQ at 3 months. Out of a total possible score of 100, the average VFQ score for all participants was 81.3 (range 0-100, SD 23.6). After correcting for treatment arm, each logMAR line of worse baseline visual acuity in the affected eye resulted in an average 1.2 points decrease on VFQ at 3 months (95% CI -1.8 to 0.6, p<0.001). Those who required therapeutic penetrating keratoplasty had an average of 25.2 points decrease on VFQ after correcting for treatment arm (95% CI -31.8 to -18.5, p<0.001). Study participants who were unemployed had on average 28.5 points decrease on VFQ (95% CI -46.9 to -10.2, p=0.002) after correcting for treatment arm. Monocular vision loss from corneal opacity due to fungal keratitis reduced vision-related quality of life. Given the relatively high worldwide burden of corneal opacity, improving treatment outcomes of corneal infections should be a public health priority. Clinicaltrials.gov Identifier: NCT00996736. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  11. Regulation of uterine progesterone receptors by the nonsteroidal anti-androgen hydroxyflutamide

    International Nuclear Information System (INIS)

    Chandrasekhar, Y.; Armstrong, D.T.

    1991-01-01

    The authors have recently reported that the anti-androgen hydroxyflutamide causes delayed implantation and exhibits antideciduogenic activity in the rat. The present experiments were conducted to examine whether hydroxyflutamide binds to the uterine progesterone receptors and/or alters the progesterone binding sites in the uterus. Cytosol and nuclear fractions from decidualized rat uterus were incubated with [3H]-R5020 without or with increasing concentrations of radioinert R5020, RU486, dihydrotestosterone, or hydroxyflutamide. From the log-dose inhibition curves, the relative binding affinity of both hydroxyflutamide and dihydrotestosterone was less than 0.1% and 2%, compared with R5020 (100%) for displacing [3H]-R5020 bound to uterine cytosol and nuclear fractions, respectively. Injection of estradiol-17 beta (1 microgram/rat) to ovariectomized prepubertal rats induced a 1.85-fold increase in uterine weight by 24 h. Hydroxyflutamide at 2.5 or 5.0 mg did not significantly alter the estrogen-induced increase in uterine weight. Compared to vehicle alone, estrogen induced an approximately 5-fold increase in uterine cytosolic progesterone binding sites. Hydroxyflutamide at both 2.5- and 5.0-mg doses significantly attenuated the estrogen-induced elevation in uterine progesterone binding sites. These studies demonstrate that hydroxyflutamide does not bind with high affinity to progesterone receptors, but suppresses the estrogen-induced elevation in progesterone receptor levels in the uterus

  12. Utility of Clinical Parameters and Multiparametric MRI as Predictive Factors for Differentiating Uterine Sarcoma From Atypical Leiomyoma.

    Science.gov (United States)

    Bi, Qiu; Xiao, Zhibo; Lv, Fajin; Liu, Yao; Zou, Chunxia; Shen, Yiqing

    2018-02-05

    The objective of this study was to find clinical parameters and qualitative and quantitative magnetic resonance imaging (MRI) features for differentiating uterine sarcoma from atypical leiomyoma (ALM) preoperatively and to calculate predictive values for uterine sarcoma. Data from 60 patients with uterine sarcoma and 88 patients with ALM confirmed by surgery and pathology were collected. Clinical parameters, qualitative MRI features, diffusion-weighted imaging with apparent diffusion coefficient values, and quantitative parameters of dynamic contrast-enhanced MRI of these two tumor types were compared. Predictive values for uterine sarcoma were calculated using multivariable logistic regression. Patient clinical manifestations, tumor locations, margins, T2-weighted imaging signals, mean apparent diffusion coefficient values, minimum apparent diffusion coefficient values, and time-signal intensity curves of solid tumor components were obvious significant parameters for distinguishing between uterine sarcoma and ALM (all P Abnormal vaginal bleeding, tumors located mainly in the uterine cavity, ill-defined tumor margins, and mean apparent diffusion coefficient values of uterine sarcoma. When the overall scores of these four predictors were greater than or equal to 7 points, the sensitivity, the specificity, the accuracy, and the positive and negative predictive values were 88.9%, 99.9%, 95.7%, 97.0%, and 95.1%, respectively. The use of clinical parameters and multiparametric MRI as predictive factors was beneficial for diagnosing uterine sarcoma preoperatively. These findings could be helpful for guiding treatment decisions. Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

  13. Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions.

    Science.gov (United States)

    Johns, Claire; Seav, Susan M; Dominick, Sally A; Gorman, Jessica R; Li, Hongying; Natarajan, Loki; Mao, Jun James; Irene Su, H

    2016-04-01

    Patient-centered decision making about hot flash treatments often incorporates a balance of efficacy and side effects in addition to patient preference. This systematic review examines randomized controlled trials (RCTs) comparing at least two non-hormonal hot flash treatments in breast cancer survivors. In July 2015, PubMed, SCOPUS, CINAHL, Cochrane, and Web of Science databases were searched for RCTs comparing active, non-hormonal hot flash treatments in female breast cancer survivors. Thirteen trials were included after identifying 906 potential studies. Four trials were dose comparison studies of pharmacologic treatments citalopram, venlafaxine, gabapentin, and paroxetine. Hot flash reduction did not differ by tamoxifen or aromatase inhibitor use. Citalopram 10, 20, and 30 mg daily had comparable outcomes. Venlafaxine 75 mg daily improved hot flashes without additional side effects from higher dosing. Gabapentin 900 mg daily improved hot flashes more than 300 mg. Paroxetine 10 mg daily had fewer side effects than 20 mg. Among four trials comparing different pharmacologic treatments, venlafaxine alleviated hot flash symptoms faster than clonidine; participants preferred venlafaxine over gabapentin. Five trials compared pharmacologic to non-pharmacologic treatments. Acupuncture had similar efficacy to venlafaxine and gabapentin but may have longer durability after completing treatment and fewer side effects. We could not perform a pooled meta-analysis because outcomes were not reported in comparable formats. Clinical trial data on non-hormonal hot flash treatments provide comparisons of hot flash efficacy and other patient important outcomes to guide clinical management. Clinicians can use the information to help patients select hot flash interventions.

  14. Randomized trial of a smartphone mobile application compared to text messaging to support smoking cessation.

    Science.gov (United States)

    Buller, David B; Borland, Ron; Bettinghaus, Erwin P; Shane, James H; Zimmerman, Donald E

    2014-03-01

    Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Young adult smokers 18-30 years old (n = 102) participated in a randomized pretest-posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and quitting behavior (quit attempts, point-prevalence, 30-day point-prevalence, and continued abstinence) were assessed in posttests. Overall, 60% of smokers used mobile services (REQ-Mobile, 61%, mean of 128.5 messages received; onQ, 59%, mean of 107.8 messages), and 75% evaluated REQ-Mobile as user-friendly. A majority of smokers reported being abstinent at posttest (6 weeks, 53% of completers; 12 weeks, 66% of completers [44% of all cases]). Also, 37% (25%of all cases) reported 30-day point-prevalence abstinence, and 32% (22% of all cases) reported continuous abstinence at 12 weeks. OnQ produced more abstinence (ptext messaging. Text messaging may work better because it is simple, well known, and delivered to a primary inbox. These advantages may disappear as smokers become more experienced with new handsets. Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging.

  15. Troxipide in the Management of Gastritis: A Randomized Comparative Trial in General Practice

    Directory of Open Access Journals (Sweden)

    Bhupesh Dewan

    2010-01-01

    Full Text Available Background. A trial of empirical acid-suppressive therapy is the usual practice for most patients with symptoms of gastritis in primary care. Aim. To assess the relative efficacy of Troxipide and Ranitidine in patients with endoscopic gastritis over a four-week period. Methods. In all, 142 patients were randomized to Troxipide (100 mg tid or Ranitidine (150 mg bid for a period of four weeks. The severity of the signs of endoscopic gastritis at baseline and week 4 using a four-point scale and the subjective symptom severity at baseline and week 2 & week 4 using a Visual analog scale (VAS were documented. Results. Troxipide was found to be superior to Ranitidine for both, the complete resolution and improvement of endoscopic gastritis. Higher proportion of patients showed complete healing of erosions (88.14%, oozing (96.77%, and edema (93.88% with Troxipide as compared to Ranitidine (<.01. Patients receiving Troxipide also showed a greater improvement in the VAS scores for abdominal pain, bloating, and heartburn (<.01. Both the drugs were found to be well tolerated. Conclusion. In patients with endoscopic gastritis, Troxipide, with its superior rate of improvement, resolution of signs, and subjective clinical symptoms, can be considered as an alternative to the commonly used antisecretory agents.

  16. Prospective controlled trial comparing colostomy irrigation with "spontaneous-action" method.

    Science.gov (United States)

    Williams, N S; Johnston, D

    1980-07-12

    Thirty randomly selected patients with permanent colostomies entered a prospective controlled trial comparing colostomy irrigation with spontaneous action. Each patient was interviewed and examined before irrigation was begun and again after the technique had been used for three months. Each then reverted to spontaneous action for a further three months and was then reassessed. Eight patients abandoned irrigation and 22 (73%) adhered to the protocol. Irrigation caused no mishaps or complications. The mean time spent managing the stoma was 45 +/- SEM 9 min/24 hours during spontaneous action and 53 +/- 9 min/24 hours during irrigation. This difference was not significant. The numbers of bowel actions weekly were 13 +/ SEM 2 during spontaneous action and 6 +/- 1 during irrigation (p Irrigation reduced odour and flatus in 20 patients and enabled 12 out of 18 to stop using drugs and seven to discard their appliance. Irrigation also improved the social life of 18 patients and the working conditions of eight out of 14. These finding show that some patients may not be suitable for irrigation but that for many it is better than the conventional British method of colostomy management. With modern apparatus the technique is safe.

  17. Explaining feast or famine in randomized field trials. Medical science and criminology compared.

    Science.gov (United States)

    Shepherd, Jonathan P

    2003-06-01

    A feast of randomized controlled trials (RCTs) in medical science and comparative famine in criminology can be explained in terms of cultural and structural factors. Of central importance is the context in which the evaluation of interventions is done and the difference in status of situational research in the two disciplines. Evaluation of medical interventions has traditionally been led by practitioner (clinical) academics. This is not the case in criminal justice, where theory has had higher status than intervention research. Medical science has advanced in, or closely associated with, university teaching hospitals, but links between criminology and criminal justice services are far more tenuous. The late development of situational crime prevention seems extraordinary from a medical perspective, as does the absence of university police schools in the United Kingdom and elsewhere. These structural and cultural factors explain concentration of expectation, resource, and RCT productivity in medical science. The Campbell Collaboration and the Academy of Experimental Criminology are forces which are reducing this polarization of feast and famine in RCTs. But unless scientific criminology is embedded in university schools which are responsible for the education and training of law, probation, and police practitioners, convergence in terms of RCTs and implementation of findings in practice seems unlikely.

  18. A Randomized Controlled Trial Comparing the Letter Project Advance Directive to Traditional Advance Directive.

    Science.gov (United States)

    Periyakoil, Vyjeyanthi S; Neri, Eric; Kraemer, Helena

    2017-09-01

    Simpler alternatives to traditional advance directives that are easy to understand and available in multiple formats and can be initiated by patients and families will help facilitate advance care planning. The goal of this study was to compare the acceptability of the letter advance directive (LAD) to the traditional advance directive (TAD) of the state of California. A web-based, randomized controlled trial was conducted, in which the participants were randomized to one of two types of advance directives (ADs): the LAD (intervention) or the TAD (control). Primary outcomes were participant ratings of the ease, value, and their level of comfort in the AD document they completed. A total of 400 participants completed the study, with 216 randomized to the LAD and 184 to the TAD by a computerized algorithm. Overall, participants preferred the LAD to the TAD (success rate difference [SRD] = 0.46, 95th percentile confidence interval [CI]: 0.36-0.56, p advance directive to be a better alternative to the traditional advance directive form.

  19. Uterine transplantation: a promising surrogate to surrogacy?

    Science.gov (United States)

    Grynberg, Michael; Ayoubi, Jean-Marc; Bulletti, Carlo; Frydman, Rene; Fanchin, Renato

    2011-03-01

    Infertility due to the inability of the uterus to carry a pregnancy ranks among the most unresolved issues in reproductive medicine. It affects millions of women worldwide who have congenital or acquired uterine affections, often requiring hysterectomy, and potentially represents a considerable fraction of the general infertile population. Patients suffering from severe uterine infertility are currently compelled to go through gestational surrogacy or adoption; both approaches, unfortunately, deprive them of the maternal experience of pregnancy and birth. Uterine transplantation represents an outstanding, yet complex, perspective to alleviating definitive uterine infertility. In the past decades, a number of scientific experiments conducted both in animals and women, focusing on uterine transplantation, have led to promising results. Collectively, these findings undoubtedly constitute a sound basis to clinically apply uterine transplantation in the near future. This paper is, however, an overview not only of the extent and limitations of accumulated scientific knowledge on uterine transplantation, but also its ethical implications, in an effort to define the actual place of such an approach among the therapeutic arsenal for alleviating infertility. © 2011 New York Academy of Sciences.

  20. Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial.

    Science.gov (United States)

    Wang, Chenchen; Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

    2018-03-21

    To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Prospective, randomized, 52 week, single blind comparative effectiveness trial. Urban tertiary care academic hospital in the United States between March 2012 and September 2016. 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group

  1. Leveraging National Cancer Institute Programmatic Collaboration for Uterine Cervix Cancer Patient Accrual in Puerto Rico

    Directory of Open Access Journals (Sweden)

    Charles A. Kunos

    2018-04-01

    Full Text Available Women in the U.S. Commonwealth of Puerto Rico (PR have a higher age-adjusted incidence rate for uterine cervix cancer than the U.S. mainland as well as substantial access and economic barriers to cancer care. The National Cancer Institute (NCI funds a Minority/Underserved NCI Community Oncology Research Program in PR (PRNCORP as part of a national network of community-based health-care systems to conduct multisite cancer clinical trials in diverse populations. Participation by the PRNCORP in NCI’s uterine cervix cancer clinical trials, however, has remained limited. This study reports on the findings of an NCI site visit in PR to assess barriers impeding site activation and accrual to its sponsored gynecologic cancer clinical trials. Qualitative, semi-structured individual, and group interviews were conducted at six PRNCORP-affiliated locations to ascertain: long-term trial accrual objectives; key stakeholders in PR that address uterine cervix cancer care; key challenges or barriers to activating and to enrolling patients in NCI uterine cervix cancer treatment trials; and resources, policies, or procedures in place or needed on the island to support NCI-sponsored clinical trials. An NCI-sponsored uterine cervix cancer radiation–chemotherapy intervention clinical trial (NCT02466971, already activated on the island, served as a test case to identify relevant patient accrual and site barriers. The site visit identified five key barriers to accrual: (1 lack of central personnel to coordinate referrals for treatment plans, medical tests, and medical imaging across the island’s clinical trial access points; (2 patient insurance coverage; (3 lack of a coordinated brachytherapy schedule at San Juan-centric service providers; (4 limited credentialed radiotherapy machines island-wide; and (5 too few radiology medical physicists tasked to credential trial-specified positron emission tomography scanners island-wide. PR offers a unique opportunity to

  2. Maternal uterine artery VEGF gene therapy for treatment of intrauterine growth restriction.

    Science.gov (United States)

    David, Anna L

    2017-11-01

    Intrauterine growth restriction (IUGR) is a serious pregnancy complication affecting approximately 8% of all pregnancies. The aetiology is believed to be insufficient maternal uteroplacental perfusion which prevents adequate nutrient and oxygen availability for the fetus. There is no treatment that can improve uteroplacental perfusion and thereby increase fetal growth in the uterus. Maternal uterine artery gene therapy presents a promising treatment strategy for IUGR, with the use of adenoviral vectors encoding for proteins such as Vascular Endothelial Growth Factor (VEGF) demonstrating improvements in fetal growth and neonatal outcome in preclinical studies. Mechanistically, maternal VEGF gene therapy delivered to the uterine arteries increases uterine blood flow and enhances vascular relaxation short term, while reducing vascular contractility long term. It also leads to vascular remodeling with increased endothelial cell proliferation in the perivascular adventitia of uterine arteries. Safety assessments suggest no vector spread to the fetus and no adverse risk to the mother or fetus; a clinical trial is in development. This article assesses research into VEGF maternal uterine artery directed gene therapy for IUGR, investigating the use of transgenes and vectors, their route of administration in obstetrics, and the steps that will be needed to take this treatment modality into the clinic. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Raisins compared with other snack effects on glycemia and blood pressure: a randomized, controlled trial.

    Science.gov (United States)

    Anderson, James W; Weiter, Kathy M; Christian, Amber L; Ritchey, Michelle B; Bays, Harold E

    2014-01-01

    To compare effects of raisin snacks with conventional snacks on glycemia and cardiovascular risk factors. A 12-week, randomized, controlled trial compared 3-times-a-day consumption of raisins with intake of processed snacks on glycemia and cardiovascular risk factors. Men and women were randomized to snacks (n = 15) or raisins (n = 31). Outcome measures were performed at baseline, 4, 8, and 12 weeks. Fasting plasma glucose levels were not significantly affected by intake of raisins or snacks. Mean subject post prandial glucose levels were significantly reduced by raisin intake at 12 weeks; changes with raisin intake were -13.1 mg/dL (P = 0.003 vs baseline; P = 0.03 vs snacks). Eating raisins significantly decreased glycated hemoglobin (HbA1c) level (-0.12%; P = 0.004), a significantly greater level decrease than seen with snack intake (P = 0.036). Snack intake did not significantly affect subject systolic or diastolic blood pressure (BP). Raisin intake was associated with reductions in systolic blood pressure (SBP) at 4, 8, and 12 weeks with mean changes of -6.0 to 10.2 mmHg; all these changes were statistically significant (P = 0.015 to 0.001). Raisins were associated with significantly greater changes in diastolic blood pressure (DBP) at 4, 8, and 12 weeks than snacks (P < 0.05). Body weight did not significantly change within or between groups. Regular consumption of raisins may reduce glycemia and cardiovascular risk factors, including BP rate.

  4. End-tidal control vs. manually controlled minimal-flow anesthesia: a prospective comparative trial.

    Science.gov (United States)

    Wetz, A J; Mueller, M M; Walliser, K; Foest, C; Wand, S; Brandes, I F; Waeschle, R M; Bauer, M

    2017-11-01

    To ensure safe general anesthesia, manually controlled anesthesia requires constant monitoring and numerous manual adjustments of the gas dosage, especially for low- and minimal-flow anesthesia. Oxygen flow-rate and administration of volatile anesthetics can also be controlled automatically by anesthesia machines using the end-tidal control technique, which ensures constant end-tidal concentrations of oxygen and anesthetic gas via feedback and continuous adjustment mechanisms. We investigated the hypothesis that end-tidal control is superior to manually controlled minimal-flow anesthesia (0.5 l/min). In this prospective trial, we included 64 patients undergoing elective surgery under general anesthesia. We analyzed the precision of maintenance of the sevoflurane concentration (1.2-1.4%) and expiratory oxygen (35-40%) and the number of necessary adjustments. Target-concentrations of sevoflurane and oxygen were maintained at more stable levels with the use of end-tidal control (during the first 15 min 28% vs. 51% and from 15 to 60 min 1% vs. 19% deviation from sevoflurane target, P tidal oxygen (5, IQR 3-6). The target-concentrations were reached earlier with the use of end-tidal compared with manual controlled minimal-flow anesthesia but required slightly greater use of anesthetic agents (6.9 vs. 6.0 ml/h). End-tidal control is a superior technique for setting and maintaining oxygen and anesthetic gas concentrations in a stable and rapid manner compared with manual control. Consequently, end-tidal control can effectively support the anesthetist. © 2017 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  5. Randomized controlled trial comparing esophageal dilation to no dilation among adults with esophageal eosinophilia and dysphagia.

    Science.gov (United States)

    Kavitt, R T; Ates, F; Slaughter, J C; Higginbotham, T; Shepherd, B D; Sumner, E L; Vaezi, M F

    2016-11-01

    The role of esophageal dilation in patients with esophageal eosinophilia with dysphagia remains unknown. The practice of dilation is currently based on center preferences and expert opinion. The aim of this study is to determine if, and to what extent, dysphagia improves in response to initial esophageal dilation followed by standard medical therapies. We conducted a randomized, blinded, controlled trial evaluating adult patients with dysphagia and newly diagnosed esophageal eosinophilia from 2008 to 2013. Patients were randomized to dilation or no dilation at time of endoscopy and blinded to dilation status. Endoscopic features were graded as major and minor. Subsequent to randomization and endoscopy, all patients received fluticasone and dexlansoprazole for 2 months. The primary study outcome was reduction in overall dysphagia score, assessed at 30 and 60 days post-intervention. Patients with severe strictures (less than 7-mm esophageal diameter) were excluded from the study. Thirty-one patients were randomized and completed the protocol: 17 randomized to dilation and 14 to no dilation. Both groups were similar with regard to gender, age, eosinophil density, endoscopic score, and baseline dysphagia score. The population exhibited moderate to severe dysphagia and moderate esophageal stricturing at baseline. Overall, there was a significant (P dysphagia score at 30 and 60 days post-randomization compared with baseline in both groups. No significant difference in dysphagia scores between treatment groups after 30 (P = 0.93) or 60 (P = 0.21) days post-intervention was observed. Esophageal dilation did not result in additional improvement in dysphagia score compared with treatment with proton pump inhibitor and fluticasone alone. In patients with symptomatic esophageal eosinophilia without severe stricture, dilation does not appear to be a necessary initial treatment strategy. © 2015 International Society for Diseases of the Esophagus.

  6. Data extraction from machine-translated versus original language randomized trial reports: a comparative study.

    Science.gov (United States)

    Balk, Ethan M; Chung, Mei; Chen, Minghua L; Chang, Lina Kong Win; Trikalinos, Thomas A

    2013-11-07

    Google Translate offers free Web-based translation, but it is unknown whether its translation accuracy is sufficient to use in systematic reviews to mitigate concerns about language bias. We compared data extraction from non-English language studies with extraction from translations by Google Translate of 10 studies in each of five languages (Chinese, French, German, Japanese and Spanish). Fluent speakers double-extracted original-language articles. Researchers who did not speak the given language double-extracted translated articles along with 10 additional English language trials. Using the original language extractions as a gold standard, we estimated the probability and odds ratio of correctly extracting items from translated articles compared with English, adjusting for reviewer and language. Translation required about 30 minutes per article and extraction of translated articles required additional extraction time. The likelihood of correct extractions was greater for study design and intervention domain items than for outcome descriptions and, particularly, study results. Translated Spanish articles yielded the highest percentage of items (93%) that were correctly extracted more than half the time (followed by German and Japanese 89%, French 85%, and Chinese 78%) but Chinese articles yielded the highest percentage of items (41%) that were correctly extracted >98% of the time (followed by Spanish 30%, French 26%, German 22%, and Japanese 19%). In general, extractors' confidence in translations was not associated with their accuracy. Translation by Google Translate generally required few resources. Based on our analysis of translations from five languages, using machine translation has the potential to reduce language bias in systematic reviews; however, pending additional empirical data, reviewers should be cautious about using translated data. There remains a trade-off between completeness of systematic reviews (including all available studies) and risk of

  7. CYberinfrastructure for COmparative effectiveness REsearch (CYCORE): improving data from cancer clinical trials.

    Science.gov (United States)

    Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan

    2011-03-01

    Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of knowledge about patients' lifestyle behaviors that may affect cancer's progression and recurrence, and limited ability to compile and interpret the wide range of variables that must be considered in the cancer treatment. This lack of data integration limits the potential for patients and clinicians to engage in fully informed decision-making regarding cancer prevention, treatment, and survivorship care, and the translation of research results into mainstream medical care. Particularly important, as noted in a 2009 report on CER to the President and Congress, the limited focus on health behavior-change interventions was a major hindrance in this research landscape (DHHS 2009). This paper describes an initiative to improve CER for cancer by addressing several of these limitations. The Cyberinfrastructure for Comparative Effectiveness Research (CYCORE) project, informed by the National Science Foundation's 2007 report "Cyberinfrastructure Vision for 21(st) Century Discovery" has, as its central aim, the creation of a prototype for a user-friendly, open-source cyberinfrastructure (CI) that supports acquisition, storage, visualization, analysis, and sharing of data important for cancer-related CER. Although still under development, the process of gathering requirements for CYCORE has revealed new ways in which CI design can significantly improve the collection and analysis of a wide variety of data types, and has resulted in new and important partnerships among cancer researchers engaged in

  8. Uterine dysfunction in biglycan and decorin deficient mice leads to dystocia during parturition.

    Directory of Open Access Journals (Sweden)

    Zhiping Wu

    Full Text Available Cesarean birth rates are rising. Uterine dysfunction, the exact mechanism of which is unknown, is a common indication for Cesarean delivery. Biglycan and decorin are two small leucine-rich proteoglycans expressed in the extracellular matrix of reproductive tissues and muscle. Mice deficient in biglycan display a mild muscular dystrophy, and, along with mice deficient in decorin, are models of Ehlers-Danlos Syndrome, a connective tissue anomaly associated with uterine rupture. As a variant of Ehlers-Danlos Syndrome is caused by a genetic mutation resulting in abnormal biglycan and decorin secretion, we hypothesized that biglycan and decorin play a role in uterine function. Thus, we assessed wild-type, biglycan, decorin and double knockout pregnancies for timing of birth and uterine function. Uteri were harvested at embryonic days 12, 15 and 18. Nonpregnant uterine samples of the same genotypes were assessed for tissue failure rate and spontaneous and oxytocin-induced contractility. We discovered that biglycan/decorin mixed double-knockout dams displayed dystocia, were at increased risk of delayed labor onset, and showed increased tissue failure in a predominantly decorin-dependent manner. In vitro spontaneous uterine contractile amplitude and oxytocin-induced contractile force were decreased in all biglycan and decorin knockout genotypes compared to wild-type. Notably, we found no significant compensation between biglycan and decorin using quantitative real time PCR or immunohistochemistry. We conclude that the biglycan/decorin mixed double knockout mouse is a model of dystocia and delayed labor onset. Moreover, decorin is necessary for uterine function in a dose-dependent manner, while biglycan exhibits partial compensatory mechanisms in vivo. Thus, this model is poised for use as a model for testing novel targets for preventive or therapeutic manipulation of uterine dysfunction.

  9. Uterine Dysfunction in Biglycan and Decorin Deficient Mice Leads to Dystocia during Parturition

    Science.gov (United States)

    Wu, Zhiping; Aron, Abraham W.; Macksoud, Elyse E.; Iozzo, Renato V.; Hai, Chi-Ming; Lechner, Beatrice E.

    2012-01-01

    Cesarean birth rates are rising. Uterine dysfunction, the exact mechanism of which is unknown, is a common indication for Cesarean delivery. Biglycan and decorin are two small leucine-rich proteoglycans expressed in the extracellular matrix of reproductive tissues and muscle. Mice deficient in biglycan display a mild muscular dystrophy, and, along with mice deficient in decorin, are models of Ehlers-Danlos Syndrome, a connective tissue anomaly associated with uterine rupture. As a variant of Ehlers-Danlos Syndrome is caused by a genetic mutation resulting in abnormal biglycan and decorin secretion, we hypothesized that biglycan and decorin play a role in uterine function. Thus, we assessed wild-type, biglycan, decorin and double knockout pregnancies for timing of birth and uterine function. Uteri were harvested at embryonic days 12, 15 and 18. Nonpregnant uterine samples of the same genotypes were assessed for tissue failure rate and spontaneous and oxytocin-induced contractility. We discovered that biglycan/decorin mixed double-knockout dams displayed dystocia, were at increased risk of delayed labor onset, and showed increased tissue failure in a predominantly decorin-dependent manner. In vitro spontaneous uterine contractile amplitude and oxytocin-induced contractile force were decreased in all biglycan and decorin knockout genotypes compared to wild-type. Notably, we found no significant compensation between biglycan and decorin using quantitative real time PCR or immunohistochemistry. We conclude that the biglycan/decorin mixed double knockout mouse is a model of dystocia and delayed labor onset. Moreover, decorin is necessary for uterine function in a dose-dependent manner, while biglycan exhibits partial compensatory mechanisms in vivo. Thus, this model is poised for use as a model for testing novel targets for preventive or therapeutic manipulation of uterine dysfunction. PMID:22253749

  10. The effect of metritis and subclinical hypocalcemia on uterine involution in dairy cows evaluated by sonomicrometry

    Science.gov (United States)

    HEPPELMANN, Maike; KRACH, Karoline; KRUEGER, Lars; BENZ, Philipp; HERZOG, Kathrin; PIECHOTTA, Marion; HOEDEMAKER, Martina; BOLLWEIN, Heinrich

    2015-01-01

    The objective of this study was to examine the effects of metritis and subclinical hypocalcemia on reduction of uterine size in dairy cows using ultrasonography and sonomicrometry. Four piezoelectric crystals were implanted via laparotomy into the myometrium of the pregnant uterine horn of 12 pluriparous Holstein Friesian cows 3 weeks before the calculated calving date. Sonometric measurements were conducted daily from 2 days before parturition (= Day 0) until Day 14 after calving and then every other day until Day 28. Distances between adjacent crystals were expressed in relation to reference values obtained before calving. The diameter of the formerly pregnant uterine horn was measured using transrectal B-Mode sonography starting on Day 10. Cows were retrospectively divided into the following groups: cows without metritis (M–; n = 7), cows with metritis (M+; n = 5), cows with normocalcemia (SH–; Ca > 2.0 mmol/l on Days 1 to 3; n = 5) and cows with subclinical hypocalcemia (SH+; Ca 0.05) sonometric measurements, but the diameter of the formerly pregnant horn was larger (P ≤ 0.05) between Days 15 and 21 in M+ cows than in M‒ cows. Reduction in uterine length in hypocalcemic cows was delayed (P ≤ 0.05) between Days 8 and 21 compared with normocalcemic cows, but the uterine horn diameter was not related to calcium status. In conclusion, both diseases affected reduction of uterine size until Day 28. Cows with metritis had a larger uterine diameter, possibly attributable to accumulation of lochia, and cows with subclinical hypocalcemia had delayed reduction of uterine length, presumably related to reduction of myometrial contractility. PMID:26400127

  11. The IDvIP trial: a two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia.

    Science.gov (United States)

    Wee, Michael Y K; Tuckey, Jenny P; Thomas, Peter; Burnard, Sara

    2011-07-08

    Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP) trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score analgesia, whether method of analgesia would be used again, use of Entonox, umbilical arterial and venous pH, fetal heart rate, meconium staining, time from delivery to first breath, Apgar scores at 5 mins, naloxone requirement, transfer to neonatal intensive care unit, neonatal haemoglobin oxygen saturation at 30, 60, 90, and 120 mins after delivery, and neonatal sedation and feeding behaviour during first 2 hours. If the trial demonstrates that diamorphine provides better analgesia

  12. Patients with uterine leiomyoma exhibit a high incidence but low mortality rate for breast cancer.

    Science.gov (United States)

    Shen, Te-Chun; Hsia, Te-Chun; Hsiao, Chieh-Lun; Lin, Cheng-Li; Yang, Chih-Yi; Soh, Khay-Seng; Liu, Liang-Chih; Chang, Wen-Shin; Tsai, Chia-Wen; Bau, Da-Tian

    2017-05-16

    The association of uterine leiomyoma with increased risk of breast cancer is controversial. Therefore, we used the National Health Insurance Research Database of Taiwan to examine breast cancer incidence and mortality among Asian patients with and without uterine leiomyoma. We compared breast cancer incidence and mortality between 22,001 newly diagnosed uterine leiomyoma patients and 85,356 individuals without uterine leiomyoma matched by age and date of diagnosis. Adjusted hazard ratios for breast cancer were estimated using the Cox model. The incidence of breast cancer was 35% higher in the uterine leiomyoma group than the leiomyoma-free group (1.65 vs. 1.22 per 1,000 individuals, p leiomyoma group (mean followed time, 3.59 ± 2.70 years) than the leiomyoma-free group (8.78%; mean followed time, 3.54 ± 2.67 years) at the endpoint of the study (p leiomyoma than in those without it, but overall mortality from breast cancer was lower in the patients with uterine leiomyoma.

  13. Diffuse uterine leiomyomatosis in a child

    International Nuclear Information System (INIS)

    Pai, Deepa; Coletti, Monette C.; Ladino-Torres, Maria; Caoili, Elaine; Elkins, Matthew

    2012-01-01

    Leiomyomas are the most common benign uterine tumor; however, this entity is relatively uncommon in the pediatric population. Although leiomyomas most commonly present as solitary uterine masses, unusual patterns of growth have been described including diffuse leiomyomatosis. In this condition, the myometrium of the uterus is symmetrically expanded by innumerable confluent leiomyomas; this pattern of growth is quite uncommon and has never been reported in a pediatric patient. This case report illustrates the imaging appearance of diffuse uterine leiomyomatosis in an otherwise healthy 16-year-old girl. (orig.)

  14. Diffuse uterine leiomyomatosis in a child

    Energy Technology Data Exchange (ETDEWEB)

    Pai, Deepa; Coletti, Monette C.; Ladino-Torres, Maria; Caoili, Elaine [University of Michigan Health System, Department of Radiology, Section of Pediatric Radiology, Ann Arbor, MI (United States); Elkins, Matthew [University of Michigan Health System, Department of Pathology, Ann Arbor, MI (United States)

    2012-01-15

    Leiomyomas are the most common benign uterine tumor; however, this entity is relatively uncommon in the pediatric population. Although leiomyomas most commonly present as solitary uterine masses, unusual patterns of growth have been described including diffuse leiomyomatosis. In this condition, the myometrium of the uterus is symmetrically expanded by innumerable confluent leiomyomas; this pattern of growth is quite uncommon and has never been reported in a pediatric patient. This case report illustrates the imaging appearance of diffuse uterine leiomyomatosis in an otherwise healthy 16-year-old girl. (orig.)

  15. Xenotransplantation of uterine leiomyoma in Wistar rats: a pilot study.

    Science.gov (United States)

    Sousa, Willane Bandeira de; Garcia, João Batista Santos; Nogueira Neto, João; Furtado, Pablo Gustavo Ribeiro; Anjos, Jonhnathan Adriano Araújo dos

    2015-07-01

    To evaluate whether xenografts derived from hysterectomized patients would implant successfully and lead to uterine leiomyoma in Wistar rats. This experimental study examined six female Wistar rats implanted with uterine leiomyoma obtained from patients who underwent hysterectomies at the gynecological surgery service of the HUUFMA. The rats were divided into two groups. Group I consisted of three rats in which the uterine leiomyoma had been implanted in the parietal peritoneum, and group II consisted of three rats in which the uterine leiomyoma was implanted in the subcutaneous tissue. The immunosuppressant mycophenolate mofetil (MMF) was administered orally by gavage (at a dose of 40 mg/kg of body weight) to prevent transplant rejection starting 15 days before the transplant and continuing throughout the entire experiment. After four weeks, necrosis and neovascularization were evaluated histologically in both groups and were classified as either absent or present. Lymphocytic inflammatory infiltration was also examined and classified as mild, moderate or intense (by hematoxylin and eosin staining), and fibrosis was classified as grade I-III (by Masson's trichrome staining). Necrosis was absent from all three rats in group I and was observed in only one rat from group II. Neovascularization was present in two rats from group I and in only one rat from group II. The lymphocytic inflammatory infiltrate was mild in two rats and moderate in one rat from group I, and it was moderate in two rats and intense in one rat from group II. Two rats from group 1 exhibited grade III fibrosis, and one rat presented grade I fibrosis. In group II, two rats presented grade I fibrosis and one rat had grade II fibrosis. When necrosis and neovascularization were evaluated as variables, group I demonstrated greater evidence of successful implantation when compared to group II, indicating that the peritoneal implantation technique produces better results than the subcutaneous approach (p

  16. Abnormal uterine bleeding in pre-menopausal women.

    Science.gov (United States)

    Singh, Sukhbir; Best, Carolyn; Dunn, Sheila; Leyland, Nicholas; Wolfman, Wendy Lynn

    2013-05-01

    . Published literature was retrieved through searches of MEDLINE and the Cochrane Library in March 2011 using appropriate controlled vocabulary (e.g. uterine hemorrhage, menorrhagia) and key words (e.g. menorrhagia, heavy menstrual bleeding, abnormal uterine bleeding). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English and published from January 1999 to March 2011. Searches were updated on a regular basis and incorporated in the guideline to February 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table). Implementation of the guideline recommendations will improve the health and well-being of women with abnormal uterine bleeding, their families, and society. The economic cost of implementing these guidelines in the Canadian health care system was not considered.

  17. No. 292-Abnormal Uterine Bleeding in Pre-Menopausal Women.

    Science.gov (United States)

    Singh, Sukhbir; Best, Carolyn; Dunn, Sheila; Leyland, Nicholas; Wolfman, Wendy Lynn

    2018-05-01

    . Published literature was retrieved through searches of MEDLINE and the Cochrane Library in March 2011 using appropriate controlled vocabulary (e. g., uterine hemorrhage, menorrhagia) and key words (e. g., menorrhagia, heavy menstrual bleeding, abnormal uterine bleeding). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English and published from January 1999 to March 2011. Searches were updated on a regular basis and incorporated in the guideline to February 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology- related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). Implementation of the guideline recommendations will improve the health and well-being of women with abnormal uterine bleeding, their families, and society. The economic cost of implementing these guidelines in the Canadian health care system was not considered. RECOMMENDATIONS. Copyright © 2018. Published by Elsevier Inc.

  18. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

    Science.gov (United States)

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  19. Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts

    NARCIS (Netherlands)

    Pagnoux, C.; Carette, S.; Khalidi, N. A.; Walsh, M.; Hiemstra, T. F.; Cuthbertson, D.; Langford, C.; Hoffman, G.; Koening, C. L.; Monach, P. A.; Moreland, L.; Mouthon, L.; Seo, P.; Specks, U.; Ytterbere, S.; Westman, K.; Hoglund, P.; Harper, L.; Flossmann, O.; Luqmani, R.; Savage, C.; Rasmussen, N.; de Groot, K.; Tesar, V.; Jayne, D.; Merkel, P. A.; Guillevin, L.; Stegeman, C. A.

    2015-01-01

    Objective. To analyse the differences between patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) entered into randomised clinical trials (RCTs) and those followed in large observational cohorts. Methods. The main characteristics and outcomes of patients with

  20. Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations

    NARCIS (Netherlands)

    K-M. Beeh (Kai-Michael); B. Hederer (Bettina); T. Glaab (Thomas); A. Müller (Achim); M.P.M.H. Rutten-van Mölken (Maureen); S. Kesten (Steven); C. Vogelmeier (Claus)

    2009-01-01

    textabstractAbstract Currently available long-acting inhaled bronchodilators (tiotropium, salmeterol, formoterol) have demonstrated beneficial effects on exacerbations in placebo-controlled trials. However, there have been no direct comparisons of these drugs with exacerbations as the primary

  1. Uterine artery embolization with Pingyangmycin lipiodol emulsion for treatment of symptomatic uterine fibroids

    International Nuclear Information System (INIS)

    Li Yanhao; Liu Biao; Zeng Qingle; Jiang Zhongpu; Chen Yong; Huang Weilang; Shen Qi; Zhao Zhongqing

    2000-01-01

    Objective: To evaluate the effectiveness and side effects of uterine arterial embolization with Pingyangmycin(a homogenous bleomycin) lipiodol emulsion(PLE) for symptomatic uterine fibroids. Methods: Uterine arterial embolization with PLE was performed in 25 patients. The improvement of symptoms and uterine size changes were followed up in 3-18 months(mean 6 months) after the procedure. Results: All but 2 cases were successfully treated bilaterally. Super-selective angiography showed enlargement of uterine artery, accompanied by tortuous branches. The uterine size was increased. The uterus itself was significantly stained and emptied slowly. Coagulation necrosis was found in resected fibroids after embolization in 3 patients. One month after the procedure, a mean 40% reduction of uterine volume was obtained in 18 followed-up cases. The clinical symptoms were relieved significantly. The main side effects were hypogastric pain(13/25),which was intense in 6 cases. Conclusion: Uterine arterial embolization with PLE is a good non-surgical therapy in symptomatic uterine fibroids with mild side effects

  2. Embolization of iatrogenic uterine pseudoaneurysm

    Directory of Open Access Journals (Sweden)

    Luca Boi

    2017-05-01

    Full Text Available Uterine artery pseudoaneurysms (UAPs are rare vascular lesions that may be life threatening if not diagnosed and properly treated. The clinical presentation of UAPs includes a spectrum of symptoms that are often associated with other and more frequent gynecologic/obstetric pathologies, both with and without vaginal bleeding, and may span from postpartum hemorrhage to the absence of symptoms. We report cases of two patients with UAP, both of whom were diagnosed with ultrasonography and contrast-enhanced computed tomography and successfully treated with transcatheter embolization. The first patient presented delayed hypovolemic shock following surgery for endometriosis, whereas the second patient suffered from postpartum hemorrhage after cesarean section. Diagnosis of UAPs relies on noninvasive imaging; transcatheter arterial embolization is an effective treatment to control bleeding in both hemodynamically stable and unstable patients.

  3. A randomized trial comparing didactics, demonstration, and simulation for teaching teamwork to medical residents.

    Science.gov (United States)

    Semler, Matthew W; Keriwala, Raj D; Clune, Jennifer K; Rice, Todd W; Pugh, Meredith E; Wheeler, Arthur P; Miller, Alison N; Banerjee, Arna; Terhune, Kyla; Bastarache, Julie A

    2015-04-01

    Effective teamwork is fundamental to the management of medical emergencies, and yet the best method to teach teamwork skills to trainees remains unknown. In a cohort of incoming internal medicine interns, we tested the hypothesis that expert demonstration of teamwork principles and participation in high-fidelity simulation would each result in objectively assessed teamwork behavior superior to traditional didactics. This was a randomized, controlled, parallel-group trial comparing three teamwork teaching modalities for incoming internal medicine interns. Participants in a single-day orientation at the Vanderbilt University Center for Experiential Learning and Assessment were randomized 1:1:1 to didactic, demonstration-based, or simulation-based instruction and then evaluated in their management of a simulated crisis by five independent, blinded observers using the Teamwork Behavioral Rater score. Clinical performance was assessed using the American Heart Association Advanced Cardiac Life Support algorithm and a novel "Recognize, Respond, Reassess" score. Participants randomized to didactics (n = 18), demonstration (n = 17), and simulation (n = 17) were similar at baseline. The primary outcome of average overall Teamwork Behavioral Rater score for those who received demonstration-based training was similar to simulation participation (4.40 ± 1.15 vs. 4.10 ± 0.95, P = 0.917) and significantly higher than didactic instruction (4.40 ± 1.15 vs. 3.10 ± 0.51, P = 0.045). Clinical performance scores were similar between the three groups and correlated only weakly with teamwork behavior (coefficient of determination [Rs(2)] = 0.267, P teamwork training by expert demonstration resulted in similar teamwork behavior to participation in high-fidelity simulation and was more effective than traditional didactics. Clinical performance was largely independent of teamwork behavior and did not differ between training modalities.

  4. A Randomized Trial Comparing Didactics, Demonstration, and Simulation for Teaching Teamwork to Medical Residents

    Science.gov (United States)

    Keriwala, Raj D.; Clune, Jennifer K.; Rice, Todd W.; Pugh, Meredith E.; Wheeler, Arthur P.; Miller, Alison N.; Banerjee, Arna; Terhune, Kyla; Bastarache, Julie A.

    2015-01-01

    Rationale: Effective teamwork is fundamental to the management of medical emergencies, and yet the best method to teach teamwork skills to trainees remains unknown. Objectives: In a cohort of incoming internal medicine interns, we tested the hypothesis that expert demonstration of teamwork principles and participation in high-fidelity simulation would each result in objectively assessed teamwork behavior superior to traditional didactics. Methods: This was a randomized, controlled, parallel-group trial comparing three teamwork teaching modalities for incoming internal medicine interns. Participants in a single-day orientation at the Vanderbilt University Center for Experiential Learning and Assessment were randomized 1:1:1 to didactic, demonstration-based, or simulation-based instruction and then evaluated in their management of a simulated crisis by five independent, blinded observers using the Teamwork Behavioral Rater score. Clinical performance was assessed using the American Heart Association Advanced Cardiac Life Support algorithm and a novel “Recognize, Respond, Reassess” score. Measurements and Main Results: Participants randomized to didactics (n = 18), demonstration (n = 17), and simulation (n = 17) were similar at baseline. The primary outcome of average overall Teamwork Behavioral Rater score for those who received demonstration-based training was similar to simulation participation (4.40 ± 1.15 vs. 4.10 ± 0.95, P = 0.917) and significantly higher than didactic instruction (4.40 ± 1.15 vs. 3.10 ± 0.51, P = 0.045). Clinical performance scores were similar between the three groups and correlated only weakly with teamwork behavior (coefficient of determination [Rs2] = 0.267, P didactics. Clinical performance was largely independent of teamwork behavior and did not differ between training modalities. PMID:25730661

  5. Contura Multi-Lumen Balloon Breast Brachytherapy Catheter: Comparative Dosimetric Findings of a Phase 4 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Arthur, Douglas W., E-mail: darthur@mcvh-vcu.edu [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Vicini, Frank A. [Michigan Healthcare Professionals/21st Century Oncology, Farmington Hills, Michigan (United States); Todor, Dorin A. [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Julian, Thomas B. [Allegheny General Hospital, Temple University School of Medicine, Pittsburgh, Pennsylvania (United States); Cuttino, Laurie W.; Mukhopadhyay, Nitai D. [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States)

    2013-06-01

    Purpose: Final dosimetric findings of a completed, multi-institutional phase 4 registry trial using the Contura Multi-Lumen Balloon (MLB) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer are presented. Methods and Materials: Three dosimetric plans with identical target coverage were generated for each patient for comparison: multilumen multidwell (MLMD); central-lumen multidwell (CLMD); and central-lumen single-dwell (CLSD) loading of the Contura catheter. For this study, a successful treatment plan achieved ideal dosimetric goals and included the following: ≥95% of the prescribed dose (PD) covering ≥95% of the target volume (TV); maximum skin dose ≤125% of the PD; maximum rib dose ≤145% of the PD; and V150 ≤50 cc and V200 ≤10 cc. Results: Between January 2008 and February 2011, 23 institutions participated. A total of 318 patients were available for dosimetric review. Using the Contura MLB, all dosimetric criteria were met in 78.93% of cases planned with MLMD versus 55.38% with the CLMD versus 37.66% with the CLSD (P≤.0001). Evaluating all patients with the full range of skin to balloon distance represented, median maximum skin dose was reduced by 12% and median maximum rib dose by 13.9% when using MLMD-based dosimetric plans compared to CLSD. The dosimetric benefit of MLMD was further demonstrated in the subgroup of patients where skin thickness was <5 mm, where MLMD use allowed a 38% reduction in median maximum skin dose over CLSD. For patients with rib distance <5 mm, the median maximum rib dose reduction was 27%. Conclusions: Use of the Contura MLB catheter produced statistically significant improvements in dosimetric capabilities between CLSD and CLMD treatments. This device approach demonstrates the ability not only to overcome the barriers of limited skin thickness and close rib proximity, but to consistently achieve a higher standard of dosimetric planning goals.

  6. Contura Multi-Lumen Balloon breast brachytherapy catheter: comparative dosimetric findings of a phase 4 trial.

    Science.gov (United States)

    Arthur, Douglas W; Vicini, Frank A; Todor, Dorin A; Julian, Thomas B; Cuttino, Laurie W; Mukhopadhyay, Nitai D

    2013-06-01

    Final dosimetric findings of a completed, multi-institutional phase 4 registry trial using the Contura Multi-Lumen Balloon (MLB) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer are presented. Three dosimetric plans with identical target coverage were generated for each patient for comparison: multilumen multidwell (MLMD); central-lumen multidwell (CLMD); and central-lumen single-dwell (CLSD) loading of the Contura catheter. For this study, a successful treatment plan achieved ideal dosimetric goals and included the following: ≥ 95% of the prescribed dose (PD) covering ≥ 95% of the target volume (TV); maximum skin dose ≤ 125% of the PD; maximum rib dose ≤ 145% of the PD; and V150 ≤50 cc and V200 ≤ 10 cc. Between January 2008 and February 2011, 23 institutions participated. A total of 318 patients were available for dosimetric review. Using the Contura MLB, all dosimetric criteria were met in 78.93% of cases planned with MLMD versus 55.38% with the CLMD versus 37.66% with the CLSD (P ≤.0001). Evaluating all patients with the full range of skin to balloon distance represented, median maximum skin dose was reduced by 12% and median maximum rib dose by 13.9% when using MLMD-based dosimetric plans compared to CLSD. The dosimetric benefit of MLMD was further demonstrated in the subgroup of patients where skin thickness was <5 mm, where MLMD use allowed a 38% reduction in median maximum skin dose over CLSD. For patients with rib distance <5 mm, the median maximum rib dose reduction was 27%. Use of the Contura MLB catheter produced statistically significant improvements in dosimetric capabilities between CLSD and CLMD treatments. This device approach demonstrates the ability not only to overcome the barriers of limited skin thickness and close rib proximity, but to consistently achieve a higher standard of dosimetric planning goals. Copyright © 2013 Elsevier Inc. All rights

  7. Cost utility analysis of co-prescribed heroin compared with methadone maintenance treatment in heroin addicts in two randomised trials

    NARCIS (Netherlands)

    Dijkgraaf, Marcel G. W.; van der Zanden, Bart P.; de Borgie, Corianne A. J. M.; Blanken, Peter; van Ree, Jan M.; van den Brink, Wim

    2005-01-01

    Objective To determine the cost utility of medical co-prescription of heroin compared with methadone maintenance treatment for chronic, treatment resistant heroin addicts. Design Cost utility analysis of two pooled open label randomised controlled trials. Setting Methadone maintenance programmes in

  8. Conservative treatment of a mandibular condyle fracture: comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

    NARCIS (Netherlands)

    van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

    2015-01-01

    Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

  9. Conservative treatment of a mandibular condyle fracture: Comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

    NARCIS (Netherlands)

    van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

    2015-01-01

    Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

  10. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

    DEFF Research Database (Denmark)

    Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois

    2014-01-01

    OBJECTIVE: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. METHODS: Subjects w...

  11. Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

    Science.gov (United States)

    Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

    2016-01-01

    Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

  12. A multicenter, randomized trial comparing synthetic surfactant with modified bovine surfactant extract in the treatment of neonatal respiratory distress syndrome

    NARCIS (Netherlands)

    Adams, E; Vollman, J; Giebner, D; Maurer, M; Dreyer, G; Bailey, L; Anderson, M; Mefford, L; Beaumont, E; Sutton, D; Puppala, B; Mangurten, HH; Secrest, J; Lewis, WJ; Carteaux, P; Bednarek, F; Welsberger, S; Gosselin, R; Pantoja, AF; Belenky, A; Campbell, P; Patole, S; Duenas, M; Kelly, M; Alejo, W; Lewallen, P; DeanLieber, S; Hanft, M; Ferlauto, J; Newell, RW; Bagwell, J; Levine, D; Lipp, RW; Harkavy, K; Vasa, R; Birenbaum, H; Broderick, KA; Santos, AQ; Long, BA; Gulrajani, M; Stern, M; Hopgood, G; Hegyi, T; Alba, J; Christmas, L; McQueen, M; Nichols, N; Brown, M; Quissell, BJ; Rusk, C; Marks, K; Gifford, K; Hoehn, G; Pathak, A; Marino, B; Hunt, P; Fox, [No Value; Sharpstein, C; Feldman, B; Johnson, N; Beecham, J; Balcom, R; Helmuth, W; Boylan, D; Frakes, C; Magoon, M; Reese, K; Schwersenski, J; Schutzman, D; Soll, R; Horbar, JD; Leahy, K; Troyer, W; Juzwicki, C; Anderson, P; Dworsky, M; Reynolds, L; Urrutia, J; Gupta, U; Adray, C

    Objective. To compare the efficacy of a synthetic surfactant (Exosurf Neonatal, Burroughs-Wellcome Co) and a modified bovine surfactant extract (Survanta, Ross Laboratories) in the treatment of neonatal respiratory distress syndrome (RDS). Design. Multicenter, randomized trial. Setting. Thirty-eight

  13. Ovarian function after uterine artery embolisation

    African Journals Online (AJOL)

    2009-08-05

    Aug 5, 2009 ... Objective. To evaluate ovarian function in 29 patients who underwent uterine artery embolisation ... of FSH levels, kidney function, blood count and clotting time. .... Funding: Departmental funds and routine services in hospital;.

  14. Methodological reporting of randomized controlled trials in major hepato-gastroenterology journals in 2008 and 1998: a comparative study

    Science.gov (United States)

    2011-01-01

    Background It was still unclear whether the methodological reporting quality of randomized controlled trials (RCTs) in major hepato-gastroenterology journals improved after the Consolidated Standards of Reporting Trials (CONSORT) Statement was revised in 2001. Methods RCTs in five major hepato-gastroenterology journals published in 1998 or 2008 were retrieved from MEDLINE using a high sensitivity search method and their reporting quality of methodological details were evaluated based on the CONSORT Statement and Cochrane Handbook for Systematic Reviews of interventions. Changes of the methodological reporting quality between 2008 and 1998 were calculated by risk ratios with 95% confidence intervals. Results A total of 107 RCTs published in 2008 and 99 RCTs published in 1998 were found. Compared to those in 1998, the proportion of RCTs that reported sequence generation (RR, 5.70; 95%CI 3.11-10.42), allocation concealment (RR, 4.08; 95%CI 2.25-7.39), sample size calculation (RR, 3.83; 95%CI 2.10-6.98), incomplete outecome data addressed (RR, 1.81; 95%CI, 1.03-3.17), intention-to-treat analyses (RR, 3.04; 95%CI 1.72-5.39) increased in 2008. Blinding and intent-to-treat analysis were reported better in multi-center trials than in single-center trials. The reporting of allocation concealment and blinding were better in industry-sponsored trials than in public-funded trials. Compared with historical studies, the methodological reporting quality improved with time. Conclusion Although the reporting of several important methodological aspects improved in 2008 compared with those published in 1998, which may indicate the researchers had increased awareness of and compliance with the revised CONSORT statement, some items were still reported badly. There is much room for future improvement. PMID:21801429

  15. Midterm Results after Uterine Artery Embolization Versus MR-Guided High-Intensity Focused Ultrasound Treatment for Symptomatic Uterine Fibroids

    Energy Technology Data Exchange (ETDEWEB)

    Froeling, V., E-mail: vera.froeling@charite.de; Meckelburg, K., E-mail: katrin.meckelburg@charite.de; Scheurig-Muenkler, C., E-mail: christian.scheurig-muenkler@charite.de; Schreiter, N. F., E-mail: nils.schreiter@charite.de; Kamp, J., E-mail: julia.kamp@charite.de; Maurer, M. H., E-mail: martin.maurer@charite.de; Beck, A., E-mail: alexander.beck@charite.de; Hamm, B., E-mail: bernd.hamm@charite.de; Kroencke, T. J., E-mail: Thomas.kroencke@charite.de [Charite-Universitaetsmedizin Berlin, Department of Radiology (Germany)

    2013-12-15

    Purpose: To compare the rate of reintervention and midterm changes in symptom severity (SS) and Total health-related quality of life (HRQoL) scores after uterine artery embolization (UAE) and magnetic resonance-guided high-intensity focused ultrasound (MR-g HIFU) for symptomatic uterine fibroids. Methods: Eighty women (median age 38.3 years), equally eligible for MR-g HIFU and UAE who underwent one of both treatments between 2002 and 2009 at our institution, were included. The primary end point of the study was defined as the rate of reintervention after both therapies. The secondary outcome was defined as changes in SS and Total HRQoL scores after treatment. SS and Total HRQoL scores before treatment and at midterm follow-up (median 13.3 months) were assessed by the uterine fibroid symptom and quality-of-life questionnaire (UFS-QoL) and compared. Results: The rate of reintervention was significantly lower after UAE than after MR-g HIFU (p = 0.002). After both treatments, SS and Total HRQoL scores improved significantly from baseline to follow-up (UAE: p < 0.001, p < 0.001; MR-g HIFU: p = 0.002, p < 0.001). Total HRQoL scores were significantly higher after UAE than after MR-g HIFU (p = 0.032). Changes in the SS scores did not differ significantly for both treatments (p = 0.061). Conclusion: UAE and MR-g HIFU significantly improved the health-related quality of life of women with symptomatic uterine fibroids. After UAE, the change in Total HRQoL score improvement was significantly better, and a significantly lower rate of reintervention was observed.

  16. Midterm Results after Uterine Artery Embolization Versus MR-Guided High-Intensity Focused Ultrasound Treatment for Symptomatic Uterine Fibroids

    International Nuclear Information System (INIS)

    Froeling, V.; Meckelburg, K.; Scheurig-Muenkler, C.; Schreiter, N. F.; Kamp, J.; Maurer, M. H.; Beck, A.; Hamm, B.; Kroencke, T. J.

    2013-01-01

    Purpose: To compare the rate of reintervention and midterm changes in symptom severity (SS) and Total health-related quality of life (HRQoL) scores after uterine artery embolization (UAE) and magnetic resonance–guided high-intensity focused ultrasound (MR-g HIFU) for symptomatic uterine fibroids. Methods: Eighty women (median age 38.3 years), equally eligible for MR-g HIFU and UAE who underwent one of both treatments between 2002 and 2009 at our institution, were included. The primary end point of the study was defined as the rate of reintervention after both therapies. The secondary outcome was defined as changes in SS and Total HRQoL scores after treatment. SS and Total HRQoL scores before treatment and at midterm follow-up (median 13.3 months) were assessed by the uterine fibroid symptom and quality-of-life questionnaire (UFS-QoL) and compared. Results: The rate of reintervention was significantly lower after UAE than after MR-g HIFU (p = 0.002). After both treatments, SS and Total HRQoL scores improved significantly from baseline to follow-up (UAE: p < 0.001, p < 0.001; MR-g HIFU: p = 0.002, p < 0.001). Total HRQoL scores were significantly higher after UAE than after MR-g HIFU (p = 0.032). Changes in the SS scores did not differ significantly for both treatments (p = 0.061). Conclusion: UAE and MR-g HIFU significantly improved the health-related quality of life of women with symptomatic uterine fibroids. After UAE, the change in Total HRQoL score improvement was significantly better, and a significantly lower rate of reintervention was observed

  17. Oncomirs Expression Profiling in Uterine Leiomyosarcoma Cells

    Directory of Open Access Journals (Sweden)

    Bruna Cristine de Almeida

    2017-12-01

    Full Text Available MicroRNAs (miRNAs are small non-coding RNAs that act as regulators of gene expression at the post-transcriptional level. They play a key role in several biological processes. Their abnormal expression may lead to malignant cell transformation. This study aimed to evaluate the expression profile of 84 miRNAs involved in tumorigenesis in immortalized cells of myometrium (MM, uterine leiomyoma (ULM, and uterine leiomyosarcoma (ULMS. Specific cell lines were cultured and qRT-PCR was performed. Thirteen miRNAs presented different expression profiles in ULM and the same thirteen in ULMS compared to MM. Eight miRNAs were overexpressed, and five were underexpressed in ULM. In ULMS cells, five miRNAs exhibited an overexpression and eight were down-regulated. Six miRNAs (miR-1-3p, miR-130b-3p, miR-140-5p, miR-202-3p, miR-205-5p, and miR-7-5p presented a similar expression pattern in cell lines compared to patient samples. Of these, only three miRNAs showed significant expression in ULM (miR-1-3p, miR-140-5p, and miR-7-5p and ULMS (miR-1-3p, miR-202-3p, and miR-7-5p. Our preliminary approach identified 24 oncomirs with an altered expression profile in ULM and ULMS cells. We identified four differentially expressed miRNAs with the same profile when compared with patients’ samples, which strongly interacted with relevant genes, including apoptosis regulator (BCL2, epidermal growth factor receptor (EGFR, vascular endothelial growth factor A (VEGFA, insulin like growth factor 1 receptor (IGF1R,serine/threonine kinase (RAF1, receptor tyrosine kinase (MET, and bHLH transcription factor (MYCN. This led to alterations in their mRNA-target.

  18. Smoking-Cessation Interventions for Urban Hospital Patients: A Randomized Comparative Effectiveness Trial.

    Science.gov (United States)

    Sherman, Scott E; Link, Alissa R; Rogers, Erin S; Krebs, Paul; Ladapo, Joseph A; Shelley, Donna R; Fang, Yixin; Wang, Binhuan; Grossman, Ellie

    2016-10-01

    Hospitalization is a unique opportunity for smoking cessation, but prior interventions have measured efficacy with narrowly defined populations. The objective of this study was to enroll smokers admitted to two "safety net" hospitals and compare the effectiveness of two post-discharge cessation interventions. A randomized comparative effectiveness trial was conducted. At two New York City public hospitals, every hospitalized patient identified as a smoker (based on admission records) was approached. Inclusion criteria were: smoked cigarettes in the past 30 days; spoke English, Spanish, or Mandarin; had a U.S. phone number; not discharged to an institution where follow-up or smoking was limited; and not pregnant/breastfeeding. Of 18,797 patients identified as current smokers between July 2011 and April 2014, a total of 3,047 (16%) were discharged before being approached, 3,273 (17%) were not current smokers, 4,026 (21%) had no U.S. phone number, 2,831 (15%) were ineligible for other reasons, and 3,983 (21%) refused participation. In total, 1,618 (9%) participants enrolled in the study. During follow-up, 69% of participants were reached at 2 months and 68% at 6 months. At discharge, participants were randomized to multisession telephone counseling from study staff (n=804) or referral to the state quitline for proactive outreach and counseling (n=814). Self-reported abstinence at 6 months was measured. Analyses were conducted in late 2015. One quarter of participants were homeless or in unstable housing, 60% had a history of substance abuse, 43% reported current hazardous drinking, and half had a psychiatric diagnosis other than substance abuse. At follow-up, the rate of abstinence (30-day point prevalence) was higher in the intensive counseling arm than the quitline arm at 2 months (29.0% vs 20.7%; relative risk=1.40; 95% CI=1.13, 1.73) and 6 months (37.4% vs 31.5%; relative risk=1.19; 95% CI=1.01, 1.40). Intensive counseling was more effective than referral to the

  19. Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial.

    Science.gov (United States)

    Neuzeret, Pierre-Charles; Morin, Laurent

    2017-11-01

    Patient interface is important for the success of continuous positive airway pressure (CPAP), but few trials have examined the influence of mask choice on CPAP adherence. To compare the impact of different nasal masks on CPAP in patients with newly-diagnosed obstructive sleep apnea (OSA). OSA patients were randomized in a 2:3 ratio to receive CPAP via different first-line nasal masks: ResMed Mirage FX® (MFX) or control mask (Fisher & Paykel Zest ® , HC407 ® or Philips EasyLife ® ). Mask acceptance, CPAP compliance and Home Care Provider (HCP) interventions were compared between groups after 3 months of CPAP therapy using modified intent-to-treat (mITT; after exclusion of patients with mouth leaks during CPAP initiation) and on-treatment (OT; CPAP adherent) analyses. Of 285 randomized patients, 90 requiring a full-face mask were excluded, leaving 195 and 151 in the mITT and OT analyses, respectively. Mask acceptance rate was higher in the MFX versus control group (mITT: 79% vs 68%, P = 0.067; OT: 90% vs 76%, P = 0.022). CPAP compliance was higher (5.9 ± 1.8 vs 5.1 ± 1.6 h/night, P = 0.011) and nasal mask issue-related HCP visits lower (3% vs 17%, P = 0.006) in the MFX group. Nasal mask failures due to mask discomfort (5% vs 1%) or unintentional leakage (5% vs 0%) were higher in control vs MFX group. Mask acceptance was significantly associated with fewer mask leaks (P = 0.002) and higher pressure therapy (P = 0.042). This study highlights differences between nasal masks for CPAP delivery and shows that initial mask selection can influence adherence and healthcare utilization during CPAP. © 2016 ResMed Germany Inc. The Clinical Respiratory Journal published by John Wiley & Sons Ltd.

  20. A prospective comparison of transvaginal ultrasonography and diagnostic hysteroscopy in the evaluation of patients with abnormal uterine bleeding: clinical implications

    NARCIS (Netherlands)

    Emanuel, M. H.; Verdel, M. J.; Wamsteker, K.; Lammes, F. B.

    1995-01-01

    We determined the diagnostic value of transvaginal ultrasonography for endometrial and intrauterine abnormalities in patients with abnormal uterine bleeding. Between June 1, 1992, and June 1, 1993, 279 consecutive patients underwent transvaginal ultrasonography. Findings were compared with the final

  1. Decidual tissue growth and regression in the guinea pig: regulation by uterine blood flow and relation to circulating progesterone concentrations.

    Science.gov (United States)

    Garris, D R

    1984-05-01

    The role of uterine blood flow (UBF) in the modulation of experimentally induced decidua formation was assessed in mature guinea pigs. The response to endometrial trauma, as indexed by uterine weight changes, was dependent upon the type of stimulus used, with deciduogenic effectiveness as follows: saline = oil = knife scratch less than scissor cut. Both the knife scratch and scissor cut techniques induced elevations in UBF compared with control values. Neither uterine weight nor UBF increased when trauma was applied to unresponsive uteri, indicating that inflammation was not the cause of uterine hyperemia. Uterine weight increased from basal levels on the day of trauma (i.e. day 5 of the estrous cycle) to a maximal weight between days 10 and 12 posttrauma. Maximal growth of the induced decidua occurred under conditions of elevated UBF. Subsequently, UBF declined between days 10 and 15 posttrauma, preceding the associate resorption of the induced decidua. During the period of decidua growth, serum progesterone levels were elevated compared with those in control animals. These data indicate that experimentally induced decidua formation in the guinea pig is associated with uterine hyperemia and increased corpus luteum activity, both of which are necessary for proper endometrial differentiation. It is hypothesized that these events mimic the uterine hyperemia associated with blastocyst implanplantation and early placentation in this species.

  2. Uterine artery embolization angiography and fertility related aspects

    Directory of Open Access Journals (Sweden)

    Irina A. Horhoianu

    2016-05-01

    Full Text Available Purpose. Uterine artery embolization is a minimally invasive technique. It applies the principle of targeted anatomical structure devascularisation with utility in fibroid conservative therapy, including for future fertility preserving status. The objective of our paper represents a description and evaluation of angiography utility as a predictive method for fertility maintenance. Material and Methods. The angiography and ultrasound aspects obtained from a prospective study in which selected patients have undergone uterine artery embolization for fertility preservation are detailed. Results. The following angiography aspects have been detected: left- right shunt and utero-ovarian collaterals; these have been compared with the ultrasound aspects related to the fibroid evolution form a volumetric and Doppler ultrasound point of view. The angiographical description predicts the impact on post embolization fibroid evolution and upon fertility. An analysis is made in order to assess the way in which angiography can contribute to fertility alteration. Conclusions. The angiography aspects during embolization and the following ultrasound aspects can represent predictive factors as to fertility evolution after uterine artery embolization.

  3. The Mechanism and Function of Epigenetics in Uterine Leiomyoma Development

    Science.gov (United States)

    Yang, Qiwei; Mas, Aymara; Diamond, Michael P.; Al-Hendy, Ayman

    2015-01-01

    Uterine leiomyomas, also known as uterine fibroids, are the most common pelvic tumors, occurring in nearly 70% of all reproductive-aged women and are the leading indication for hysterectomy worldwide. The development of uterine leiomyomas involve a complex and heterogeneous constellation of hormones, growth factors, stem cells, genetic, and epigenetic abnormalities. An increasing body of evidence emphasizes the important contribution of epigenetics in the pathogenesis of leiomyomas. Genome-wide methylation analysis demonstrates that a subset of estrogen receptor (ER) response genes exhibit abnormal hypermethylation levels that are inversely correlated with their RNA expression. Several tumor suppressor genes, including Kruppel-like factor 11 (KLF11), deleted in lung and esophageal cancer 1 (DLEC1), keratin 19 (KRT19), and death-associated protein kinase 1 (DAPK1) also display higher hypermethylation levels in leiomyomas when compared to adjacent normal tissues. The important role of active DNA demethylation was recently identified with regard to the ten-eleven translocation protein 1 and ten-eleven translocation protein 3-mediated elevated levels of 5-hydroxymethylcytosine in leiomyoma. In addition, both histone deacetylase and histone methyltransferase are reported to be involved in the biology of leiomyomas. A number of deregulated microRNAs have been identified in leiomyomas, leading to an altered expression of their targets. More recently, the existence of side population (SP) cells with characteristics of tumor-initiating cells have been characterized in leiomyomas. These SP cells exhibit a tumorigenic capacity in immunodeficient mice when exposed to 17β-estradiol and progesterone, giving rise to fibroid-like tissue in vivo. These new findings will likely enhance our understanding of the crucial role epigenetics plays in the pathogenesis of uterine leiomyomas as well as point the way to novel therapeutic options. PMID:25922306

  4. [Hysteroscopic polypectomy, treatment of abnormal uterine bleeding].

    Science.gov (United States)

    de Los Rios, P José F; López, R Claudia; Cifuentes, P Carolina; Angulo, C Mónica; Palacios-Barahona, Arlex U

    2015-07-01

    To evaluate the effectiveness of the hysteroscopic polypectomy in terms of the decrease of the abnormal uterine bleeding. A cross-sectional and analytical study was done with patients to whom a hysteroscopic polypectomy was done for treating the abnormal uterine bleeding, between January 2009 and December 2013. The response to the treatment was evaluated via a survey given to the patients about the behavior of the abnormal uterine bleeding after the procedure and about overall satisfaction. The results were obtained after a hysteroscopic polypectomy done to 128 patients and were as follows. The average time from the polypectomy applied until the survey was 30.5 months, with a standard deviation of 18 months. 67.2% of the patients reported decreased abnormal uterine bleeding and the 32.8% reported a persistence of symptoms. On average 82.8% of the. patients were satisfied with the treatment. Bivariate and multivariate analysis showed no association between the variables studied and no improvement of abnormal uterine bleeding after surgery (polypectomy). There were no complications. Hysteroscopic polypectomy is a safe surgical treatment, which decreases on two of three patients the abnormal uterine bleeding in the presence of endometrial polyps, with an acceptable level of satisfaction.

  5. Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

    Science.gov (United States)

    Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

    2017-09-26

    Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and

  6. Assessment of Organ Radiation Dose Associated with Uterine Artery Embolization

    International Nuclear Information System (INIS)

    Glomset, O.; Hellesnes, J.; Heimland, N.; Hafsahl, G.; Smith, H.J.

    2006-01-01

    Purpose: To evaluate the radiation dose to the skin, uterus, and ovaries during uterine artery embolization. Material and Methods: Guided uterine artery embolization for leiomyomata and two types of X-ray equipment with different dose levels were utilized during fluoroscopy in 20 women (ages ranging from 32 to 52 years, body weights from 55 to 68 kg). The first 13 women were treated using a non-pulsed system A, with 3.3 mm Al filtering and, for simplicity, a fixed peak voltage 80 kV. During treatment of the other 7 women, a pulsed system B with 5.4 mm Al filtering and an identical fixed voltage was used. The dose area product (DAP) was recorded. The vaginal dose of the first 13 patients and the peak skin dose of all patients were measured with thermoluminescent dosimeters (TLDs). TLDs were placed in the posterior vaginal fornix and on the skin at the beam entrance site. The uterine and ovarian doses were estimated based on the measured skin doses, normalized depth dose, and organ depth values. The effective dose (D eff ) was estimated based on the observed DAP values. The measured vaginal doses and the corresponding estimated uterine doses were compared statistically, as were the DAP values from systems A and B. Results: For system A, the mean fluoroscopic time was 20.9 min (range 12.7-31.1), and for system B 35.9 min (range 16.4-55.4). The mean numbers of angiographic exposures for systems A and B were 82 (range 30-164) and 37 (range 20-72), respectively. The mean peak skin dose for system A was 601.5 mGy (range 279-1030) and for system B 453 mGy (range 257-875). The mean DAP for system A was 88.6 Gy cm 2 (range 41.4-161.0) and for system B 52.5 Gy cm 2 (range 20.1-107.9). Statistical analysis showed a significant difference between the DAP values, the DAP for system B being the lower one. The mean estimated effective doses from systems A and B were 32 mSv (range 15.1-58.4) and 22 mSv (range 9-46), respectively. The mean estimated maximum uterine and ovarian doses

  7. Insufficiency Fractures After Pelvic Radiation Therapy for Uterine Cervical Cancer: An Analysis of Subjects in a Prospective Multi-institutional Trial, and Cooperative Study of the Japan Radiation Oncology Group (JAROG) and Japanese Radiation Oncology Study Group (JROSG)

    Energy Technology Data Exchange (ETDEWEB)

    Tokumaru, Sunao, E-mail: tokumaru@cc.saga-u.ac.jp [Department of Heavy Particle Therapy and Radiation Oncology, Saga University, Saga (Japan); Toita, Takafumi [Department of Radiology, Graduate School of Medical Science, University of the Ryukyus, Okinawa (Japan); Oguchi, Masahiko [Radiation Oncology Department, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo (Japan); Ohno, Tatsuya [Gunma University Heavy Ion Medical Center, Maebashi (Japan); Kato, Shingo [Department of Radiation Oncology, Saitama Medical University, International Medical Center, Saitama (Japan); Niibe, Yuzuru [Department of Radiology, School of Medicine, Kitasato University, Sagamihara (Japan); Kazumoto, Tomoko [Department of Radiology, Saitama Cancer Center, Saitama (Japan); Kodaira, Takeshi [Department of Radiation Oncology, Aichi Cancer Center, Nagoya (Japan); Kataoka, Masaaki [Department of Radiology, National Shikoku Cancer Center, Matsuyama (Japan); Shikama, Naoto [Department of Radiation Oncology, Saitama Medical University, International Medical Center, Saitama (Japan); Kenjo, Masahiro [Department of Radiation Oncology, Graduate School of Medical Science, Hiroshima University, Hiroshima (Japan); Yamauchi, Chikako [Department of Radiation Oncology, Shiga Medical Center for Adults, Moriyama (Japan); Suzuki, Osamu [Department of Radiation Oncology, Osaka Medical Center for Cancer, Osaka (Japan); Sakurai, Hideyuki [Proton Medical Research Center and Tsukuba University, Tuskuba (Japan); Teshima, Teruki [Department of Medical Physics and Engineering, Graduate School of Medicine, Osaka University, Suita (Japan); Kagami, Yoshikazu [Department of Radiology, Showa University School of Medicine, Tokyo (Japan); Nakano, Takashi [Department of Radiation Oncology, Gunma University, Graduate School of Medicine, Maebashi (Japan); Hiraoka, Masahiro [Department of Radiation Oncology and Image-applied Therapy, Kyoto University, Graduate School of Medicine, Kyoto (Japan); and others

    2012-10-01

    Purpose: To investigate pelvic insufficiency fractures (IF) after definitive pelvic radiation therapy for early-stage uterine cervical cancer, by analyzing subjects of a prospective, multi-institutional study. Materials and Methods: Between September 2004 and July 2007, 59 eligible patients were analyzed. The median age was 73 years (range, 37-84 years). The International Federation of Gynecologic Oncology and Obstetrics stages were Ib1 in 35, IIa in 12, and IIb in 12 patients. Patients were treated with the constant method, which consisted of whole-pelvic external-beam radiation therapy of 50 Gy/25 fractions and high-dose-rate intracavitary brachytherapy of 24 Gy/4 fractions without chemotherapy. After radiation therapy the patients were evaluated by both pelvic CT and pelvic MRI at 3, 6, 12, 18, and 24 months. Diagnosis of IF was made when the patients had both CT and MRI findings, neither recurrent tumor lesions nor traumatic histories. The CT findings of IF were defined as fracture lines or sclerotic linear changes in the bones, and MRI findings of IF were defined as signal intensity changes in the bones, both on T1- and T2-weighted images. Results: The median follow-up was 24 months. The 2-year pelvic IF cumulative occurrence rate was 36.9% (21 patients). Using Common Terminology Criteria for Adverse Events version 3.0, grade 1, 2, and 3 IF were seen in 12 (21%), 6 (10%), and 3 patients (5%), respectively. Sixteen patients had multiple fractures, so IF were identified at 44 sites. The pelvic IF were frequently seen at the sacroileal joints (32 sites, 72%). Nine patients complained of pain. All patients' pains were palliated by rest or non-narcotic analgesic drugs. Higher age (>70 years) and low body weight (<50 kg) were thought to be risk factors for pelvic IF (P=.007 and P=.013, Cox hazard test). Conclusions: Cervical cancer patients with higher age and low body weight may be at some risk for the development of pelvic IF after pelvic radiation therapy.

  8. Employment and paid work among participants in a randomized controlled trial comparing diacetylmorphine and hydromorphone.

    Science.gov (United States)

    Nikoo, Mohammadali; Vogel, Marc; Choi, Fiona; Song, Michael J; Burghardt, Jensen; Zafari, Zafar; Tabi, Katarina; Frank, Anastasia; Barbic, Skye; Schütz, Christian; Jang, Kerry; Krausz, Michael

    2018-04-12

    Employment is one of the less studied but a significant outcome of medication-assisted treatment. Thus, we aimed to explore employment outcomes of medication-assisted treatment with hydromorphone (HDM) or diacetylmorphine (DAM). The secondary aim was to estimate characteristics of this population as well as treatment-related factors associated with these outcomes. This was a secondary analysis of a randomized, double blind controlled trial. A total of 102 and 100 participants were randomized to receive injectable DAM or HDM for 6 months respectively. In stage 2, 144 participants were randomized again to receive either oral or injectable forms of the medication they received for another 6 months. Participants were interviewed at 5 timepoints: before and 3, 6, 9 and 12 months after treatment assignment. Generalized estimating equations (GEE) with a logit link was fitted to determine factors related to paid work in the past 30 days. Mean age of participants was 44.3 (SD = 9.6) and 59 (29.2%) participants were men. At each timepoint, 6-8 (3.6%-4.1%) participants reported employment in the past 30 days and 40 to 52 (19.7%-26.7%) reported minimum 1 day of paid work. University or college education [OR = 2.12: 95% CI = (1.25, 3.62), P = 0.01] was significantly associated with paid work after adjustment for age, gender, treatment arms, timepoints, days receiving study treatment, physical health, psychological health and crack cocaine use in the past 30 days. The rate of employment was lower among participants of this study compared to similar studies on heroin-assisted treatment. Higher education was associated with increased odds of paid work. A large gap exists between employment rate and the proportion of participants who reported paid work. Supported employment and occupational therapy could optimize the employment outcomes of this population. Copyright © 2018 Elsevier B.V. All rights reserved.

  9. A Randomized Clinical Trial Comparing Methotrexate and Mycophenolate Mofetil for Non-Infectious Uveitis

    Science.gov (United States)

    Rathinam, Sivakumar R; Babu, Manohar; Thundikandy, Radhika; Kanakath, Anuradha; Nardone, Natalie; Esterberg, Elizabeth; Lee, Salena M; Enanoria, Wayne TA; Porco, Travis C; Browne, Erica N; Weinrib, Rachel; Acharya, Nisha R

    2014-01-01

    Objective To compare the relative effectiveness of methotrexate and mycophenolate mofetil for non-infectious intermediate uveitis, posterior uveitis, or panuveitis. Design Multicenter, block-randomized, observer-masked clinical trial Participants Eighty patients with non-infectious intermediate, posterior or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore, India. Intervention Patients were randomized to receive 25mg weekly oral methotrexate or 1g twice daily oral mycophenolate mofetil and were monitored monthly for 6 months. Oral prednisone and topical corticosteroids were tapered. Main Outcome Measures Masked examiners assessed the primary outcome of treatment success, defined by achieving the following at 5 and 6 months: (1) ≤0.5+ anterior chamber cells, ≤0.5+ vitreous cells, ≤0.5+ vitreous haze and no active retinal/choroidal lesions in both eyes, (2) ≤ 10 mg of prednisone and ≤ 2 drops of prednisolone acetate 1% a day and (3) no declaration of treatment failure due to intolerability or safety. Additional outcomes included time to sustained corticosteroid-sparing control of inflammation, change in best spectacle-corrected visual acuity, resolution of macular edema, adverse events, subgroup analysis by anatomic location, and medication adherence. Results Forty-one patients were randomized to methotrexate and 39 to mycophenolate mofetil. A total of 67 patients (35 methotrexate, 32 mycophenolate mofetil) contributed to the primary outcome. Sixty-nine percent of patients achieved treatment success with methotrexate and 47% with mycophenolate mofetil (p=0.09). Treatment failure due to adverse events or tolerability was not significantly different by treatment arm (p=0.99). There were no statistically significant differences between treatment groups in time to corticosteroid-sparing control of inflammation (p=0.44), change in best spectacle-corrected visual acuity (p=0.68), and resolution of macular

  10. A randomized clinical trial comparing methotrexate and mycophenolate mofetil for noninfectious uveitis.

    Science.gov (United States)

    Rathinam, Sivakumar R; Babu, Manohar; Thundikandy, Radhika; Kanakath, Anuradha; Nardone, Natalie; Esterberg, Elizabeth; Lee, Salena M; Enanoria, Wayne T A; Porco, Travis C; Browne, Erica N; Weinrib, Rachel; Acharya, Nisha R

    2014-10-01

    To compare the relative effectiveness of methotrexate and mycophenolate mofetil for noninfectious intermediate uveitis, posterior uveitis, or panuveitis. Multicenter, block-randomized, observer-masked clinical trial. Eighty patients with noninfectious intermediate, posterior, or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore, India. Patients were randomized to receive 25 mg weekly oral methotrexate or 1 g twice daily oral mycophenolate mofetil and were monitored monthly for 6 months. Oral prednisone and topical corticosteroids were tapered. Masked examiners assessed the primary outcome of treatment success, defined by achieving the following at 5 and 6 months: (1) ≤0.5+ anterior chamber cells, ≤0.5+ vitreous cells, ≤0.5+ vitreous haze and no active retinal/choroidal lesions in both eyes, (2) ≤10 mg of prednisone and ≤2 drops of prednisolone acetate 1% a day, and (3) no declaration of treatment failure because of intolerability or safety. Additional outcomes included time to sustained corticosteroid-sparing control of inflammation, change in best spectacle-corrected visual acuity, resolution of macular edema, adverse events, subgroup analysis by anatomic location, and medication adherence. Forty-one patients were randomized to methotrexate and 39 to mycophenolate mofetil. A total of 67 patients (35 methotrexate, 32 mycophenolate mofetil) contributed to the primary outcome. Sixty-nine percent of patients achieved treatment success with methotrexate and 47% with mycophenolate mofetil (P = 0.09). Treatment failure from adverse events or tolerability was not different by treatment arm (P = 0.99). There were no differences between treatment groups in time to corticosteroid-sparing control of inflammation (P = 0.44), change in best spectacle-corrected visual acuity (P = 0.68), or resolution of macular edema (P = 0.31). There was no statistically significant difference in corticosteroid-sparing control of

  11. Randomized clinical trial comparing control of maxillary anchorage with 2 retraction techniques.

    Science.gov (United States)

    Xu, Tian-Min; Zhang, Xiaoyun; Oh, Hee Soo; Boyd, Robert L; Korn, Edward L; Baumrind, Sheldon

    2010-11-01

    The objective of this pilot randomized clinical trial was to investigate the relative effectiveness of anchorage conservation of en-masse and 2-step retraction techniques during maximum anchorage treatment in patients with Angle Class I and Class II malocclusions. Sixty-four growing subjects (25 boys, 39 girls; 10.2-15.9 years old) who required maximum anchorage were randomized to 2 treatment techniques: en-masse retraction (n = 32) and 2-step retraction (n = 32); the groups were stratified by sex and starting age. Each patient was treated by a full-time clinic instructor experienced in the use of both retraction techniques at the orthodontic clinic of Peking University School of Stomatology in China. All patients used headgear, and most had transpalatal appliances. Lateral cephalograms taken before treatment and at the end of treatment were used to evaluate treatment-associated changes. Differences in maxillary molar mesial displacement and maxillary incisor retraction were measured with the before and after treatment tracings superimposed on the anatomic best fit of the palatal structures. Differences in mesial displacement of the maxillary first molar were compared between the 2 treatment techniques, between sexes, and between different starting-age groups. Average mesial displacement of the maxillary first molar was slightly less in the en-masse group than in the 2-step group (mean, -0.36 mm; 95% CI, -1.42 to 0.71 mm). The average mesial displacement of the maxillary first molar for both treatment groups pooled (n = 63, because 1 patient was lost to follow-up) was 4.3 ± 2.1 mm (mean ± standard deviation). Boys had significantly more mesial displacement than girls (mean difference, 1.3 mm; P <0.03). Younger adolescents had significantly more mesial displacement than older adolescents (mean difference, 1.3 mm; P <0.02). Average mesial displacement of the maxillary first molar with 2-step retraction was slightly greater than that for en-masse retraction, but the

  12. Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

    Science.gov (United States)

    Taveras, Elsie M; Marshall, Richard; Kleinman, Ken P; Gillman, Matthew W; Hacker, Karen; Horan, Christine M; Smith, Renata L; Price, Sarah; Sharifi, Mona; Rifas-Shiman, Sheryl L; Simon, Steven R

    2015-06-01

    Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1

  13. Comparative prospective randomized trial: laparoscopic versus open common bile duct exploration

    Directory of Open Access Journals (Sweden)

    Vladimir Grubnik

    2011-06-01

    Full Text Available Introduction: Single-stage laparoscopic procedures for common bile duct (CBD stones are an alternative treatmentoption to two-stage endo-laparoscopic treatment and to open choledocholithotomy. Several reports have demonstratedthe feasibility, safety, efficiency and cost-effectiveness of laparoscopic techniques.Aim: To analyse the safety and benefits of laparoscopic compared to open common bile duct (CBD exploration.Material and methods: The prospective randomized trial included a total of 256 patients with CBD stones operated from2005 to 2009 in a single centre. The male/female ratio was 82/174, with a median age 62.3 ±5.8 years (range 27 to 87years. There were two groups of patients. Group I: laparoscopic CBD exploration (138 patients. Group II: open CBD exploration(118 patients. Patient comorbidity was assessed by means of the American Society of Anesthesiologists (ASA classification;ASA II – 109 patients, ASA III – 59 patients. Bile duct stones were visualized preoperatively by means of US examinationin 129 patients, by means of ERCP in 26 patients, and by magnetic resonance cholangiopancreatography (MRCPin 72 patients. Preoperative evaluation was done through medical history, biochemical tests and ultrasonography.Results: The mean duration of laparoscopic procedures was 82 min (range 40-160 min. The mean duration of openprocedures was 90 min (range 60-150 min. Mean blood loss was much lower in the laparoscopic group than in theopen group (20 ±2 v.s 285 ±27, p < 0.01. Postoperative complications were observed in 7 patients of the laparoscopicgroup and in 15 patients in the open group (p < 0.01. Laparoscopic common bile duct exploration was performedthrough a trans-cystic approach in 76 patients and via choledochotomy in 62 patients. The transcystic approach wassuccessful in 76 patients (74.5%. External drainage was used in 25 (32.8% patients with the transcystic approach.Conclusions: Laparoscopic CBD exploration can be performed with

  14. Mid-term Clinical Results and Patient Satisfaction After Uterine Artery Embolization in Women with Symptomatic Uterine Fibroids

    International Nuclear Information System (INIS)

    Smeets, Albert J.; Lohle, Paul N. M.; Vervest, Harry A. M.; Boekkooi, P. Focco; Lampmann, Leo E.H.

    2006-01-01

    Purpose. To evaluate the mid-term clinical results and patient satisfaction following uterine artery embolization (UAE) in women with symptomatic fibroids. Methods. Between August 1998 and December 2002, 135 patients had UAE for symptomatic uterine fibroids. All patients were asked to fill in a questionnaire. Questions were aimed at changes in bleeding, pain, and bulk-related symptoms. Symptoms after UAE were scored as disappeared, improved, unchanged or worsened. Adverse events were noted, such as vaginal dryness and discharge, menopausal complaints or fibroid expulsion. Patient satisfaction after UAE was assessed. Patient satisfaction of women embolized with polyvinyl alcohol (PVA) particles was compared with satisfaction of women embolized with calibrated microspheres. Results. The questionnaire was returned by 110 of 135 women (81%) at a median time interval of 14 months following UAE. In 10 women additional embolization or hysterectomy had been performed. Of the 110 responders, 86 (78%) were satisfied with the result of UAE. The proportion of satisfied women was higher in the group embolized with calibrated microspheres than in women embolized with PVA, although this difference was not statistically significant (p = 0.053). Conclusion. UAE in women with symptomatic uterine fibroids leads to improvement of symptoms and patient satisfaction is good in the vast majority after a median follow-up period of 14 months

  15. Pre-trial quality assurance processes for an intensity-modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre Phase III trial comparing conventional radiotherapy and parotid-sparing IMRT for locally advanced head and neck cancer.

    Science.gov (United States)

    Clark, C H; Miles, E A; Urbano, M T Guerrero; Bhide, S A; Bidmead, A M; Harrington, K J; Nutting, C M

    2009-07-01

    The purpose of this study was to compare conventional radiotherapy with parotid gland-sparing intensity-modulated radiation therapy (IMRT) using the PARSPORT trial. The validity of such a trial depends on the radiotherapy planning and delivery meeting a defined standard across all centres. At the outset, many of the centres had little or no experience of delivering IMRT; therefore, quality assurance processes were devised to ensure consistency and standardisation of all processes for comparison within the trial. The pre-trial quality assurance (QA) programme and results are described. Each centre undertook exercises in target volume definition and treatment planning, completed a resource questionnaire and produced a process document. Additionally, the QA team visited each participating centre. Each exercise had to be accepted before patients could be recruited into the trial. 10 centres successfully completed the quality assurance exercises. A range of treatment planning systems, linear accelerators and delivery methods were used for the planning exercises, and all the plans created reached the standard required for participation in this multicentre trial. All 10 participating centres achieved implementation of a comprehensive and robust IMRT programme for treatment of head and neck cancer.

  16. Long-term follow up after uterine artery embolization for symptomatic uterine leiomyomas

    DEFF Research Database (Denmark)

    Poulsen, Bente; Munk, Torben; Ravn, Pernille

    2011-01-01

    Uterine artery embolization is one of the established treatment options for symptomatic uterine leiomyomas, with a proven effect on the size of leiomyomas and providing short-term relief of symptoms. Only few studies have addressed long-term satisfaction with the treatment. We conducted...

  17. Expanding the Evidence Base: Comparing Randomized Controlled Trials and Observational Studies of Statins

    NARCIS (Netherlands)

    Atar, Dan; Ong, Seleen; Lansberg, Peter J.

    2015-01-01

    It is widely accepted that randomized controlled trials (RCTs) are the gold standard for demonstrating the efficacy of a given therapy (results under ideal conditions). Observational studies, on the other hand, can complement this by demonstrating effectiveness (results under real-world conditions).

  18. Explaining Feast or Famine in Randomized Field Trials: Medical Science and Criminology Compared.

    Science.gov (United States)

    Shepherd, Jonathan P.

    2003-01-01

    Discusses the contrast between the frequency of randomized clinical trials in the health sciences and the relative famine of such studies in criminology. Attributes this difference to the contexts in which research is done and the difference in the status of situational research in the two disciplines. (SLD)

  19. Outcome of assisted reproduction in women with congenital uterine anomalies: a prospective observational study.

    Science.gov (United States)

    Prior, M; Richardson, A; Asif, S; Polanski, L; Parris-Larkin, M; Chandler, J; Fogg, L; Jassal, P; Thornton, J G; Raine-Fenning, N J

    2018-01-01

    To assess the prevalence of congenital uterine anomalies, including arcuate uterus, and their effect on reproductive outcome in subfertile women undergoing assisted reproduction. Consecutive women referred for subfertility between May 2009 and November 2015 who underwent assisted reproduction were included in the study. As part of the initial assessment, each woman underwent three-dimensional transvaginal sonography. Uterine morphology was classified using the modified American Fertility Society (AFS) classification of congenital uterine anomalies proposed by Salim et al. If the external contour of the uterus was uniformly convex or had an indentation of Reproductive outcomes, including live birth, clinical pregnancy and preterm birth, were compared between women with a normal uterus and those with a congenital uterine anomaly. Subgroup analysis by type of uterine morphology and logistic regression analysis adjusted for age, body mass index, levels of anti-Müllerian hormone, antral follicle count and number and day of embryo transfer were performed. A total of 2375 women were included in the study, of whom 1943 (81.8%) had a normal uterus and 432 (18.2%) had a congenital uterine anomaly. The most common anomalies were arcuate (n = 387 (16.3%)) and subseptate (n = 16 (0.7%)) uterus. The rate of live birth was similar between women with a uterine anomaly and those with a normal uterus (35% vs 37%; P = 0.47). The rates of clinical pregnancy, mode of delivery and sex of the newborn were also similar between the two groups. Preterm birth before 37 weeks' gestation was more common in women with uterine anomalies than in controls (22% vs 14%, respectively; P = 0.03). Subgroup analysis by type of anomaly showed no difference in the incidence of live birth and clinical pregnancy for women with an arcuate uterus, but indicated worse pregnancy outcome in women with other major anomalies (P = 0.042 and 0.048, respectively). Congenital uterine anomalies as a whole, when

  20. 3D power Doppler ultrasound assessment of placental perfusion during uterine contraction in labor.

    Science.gov (United States)

    Sato, Miki; Noguchi, Junko; Mashima, Masato; Tanaka, Hirokazu; Hata, Toshiyuki

    2016-09-01

    To assess placental perfusion during spontaneous or induced uterine contraction in labor at term using placental vascular sonobiopsy (PVS) by 3D power Doppler ultrasound with the VOCAL imaging analysis program. PVS was performed in 50 normal pregnancies (32 in spontaneous labor group [SLG], and 18 in induced labor group with oxytocin or prostaglandin F2α [ILG]) at 37-41 weeks of gestation to assess placental perfusion during uterine contraction in labor. Only pregnancies with an entirely visualized anterior placenta were included in the study. Data acquisition was performed before, during (at the peak of contraction), and after uterine contraction. 3D power Doppler indices such as the vascularization index (VI), flow index (FI), and vascularization flow index (VFI) were calculated in each placenta. There were no abnormal fetal heart rate tracings during contraction in either group. VI and VFI values were significantly reduced during uterine contraction in both groups (SLG, -33.4% [-97.0-15.2%], and ILG, -49.6% [-78.2--4.0%]), respectively (P power Doppler indices (VI, FI, and VFI) during uterine contraction (at the peak of contraction) showed a correlation greater than 0.7, with good intra- and inter-observer agreements. Our findings suggest that uterine contraction in both spontaneous and induced labors causes a significant reduction in placental perfusion. Reduced placental blood flow in induced uterine contraction has a tendency to be marked compared with that in spontaneous uterine contraction. To the best of our knowledge, this is the first study on the non-invasive assessment of placental perfusion during uterine contraction in labor using 3D power Doppler ultrasound. However, the data and their interpretation in the present study should be taken with some degree of caution because of the small number of subjects studied. Further studies involving a larger sample size are needed to assess placental perfusion and vascularity using PVS during normal and

  1. Diffusion-weighted imaging properties of uterine fibroids pre- and post-uterine fibroid embolisation

    Energy Technology Data Exchange (ETDEWEB)

    Kirpalani, Anish, E-mail: kirpalania@smh.ca [Department of Medical Imaging, University of Toronto, St. Michael’s Hospital, 30 Bond Street, 3CC, Toronto, ON M5B 1W8 (Canada); Chong, Jennifer [Department of Medical Imaging, University of Toronto, St. Michael’s Hospital, 30 Bond Street, 3CC, Toronto, ON M5B 1W8 (Canada); Yang, Natalie [Department of Radiology, Austin Health, Heidelberg, Victoria 3084 (Australia); Jenkins, Sarah J. [Department of Radiology, Memorial University of Newfoundland, St. John’s, NL A1B 3V6 (Canada); Nisenbaum, Rosane [Centre for Research on Inner City Health, the Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Dalla Lana School of Public Health, University of Toronto, 30 Bond Street, Toronto, ON M5B 1W8 (Canada); Prabhudesai, Vikramaditya; Anthwal, Shalini; Colak, Errol [Department of Medical Imaging, University of Toronto, St. Michael’s Hospital, 30 Bond Street, 3CC, Toronto, ON M5B 1W8 (Canada)

    2014-09-15

    Highlights: • Change in ADC and contrast enhancement of uterine fibroids following UFE was studied. • ADC of fibroids rises post-UFE. Previous studies assessing this change have conflicting results. • ADC rise post-UFE is associated with degree of loss of contrast enhancement. • ADC measurement using DWI is not yet a proven replacement for GBCA-enhanced MRI. - Abstract: Objective: To determine the change in apparent diffusion coefficient (ADC) of uterine fibroids following uterine fibroid embolisation (UFE), and if the ADC change correlates with either volume loss or degree of contrast enhancement post-UFE. Materials and methods: This study was approved by our institutional review board with waiver of consent. The pelvic MRI examinations, including diffusion-weighted MRI (DWI) using 4 b-values, of 50 consecutive patients prior to and 6 months post-UFE were analyzed. The volume, ADC and amount of enhancement were calculated for each fibroid both pre- and post-UFE. The percent residual enhancement for each fibroid was categorized as either: no (0–1%) residual enhancement or residual (>1%) enhancement. Statistical analysis compared ADC, enhancement and volume for each fibroid pre- and post-UFE using paired t-tests and Pearson correlation coefficients. Results: The mean ADC of all (n = 88) fibroids pre-UFE was 1.30 ± 0.20 × 10{sup −3} mm{sup 2}/s, and increased to 1.68 ± 0.24 × 10{sup −3} mm{sup 2}/s post-UFE (p < 0.0001). Lower pre-UFE ADC correlated with greater ADC change post-UFE (r = −0.50; p < 0.0001). There was no correlation between ADC change and volume change post-UFE (r = 0.07; p = 0.59). However, fibroids with no residual enhancement post-UFE had larger ADC change than those with residual enhancement (p = 0.003). Conclusion: The ADC of fibroids rises post-UFE. ADC change post-UFE is associated with the degree of loss of enhancement and may therefore be valuable in predicting response to treatment in pre-procedural counseling.

  2. The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique

    Directory of Open Access Journals (Sweden)

    Gerritsen Pieter G

    2009-09-01

    Full Text Available Abstract Background Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain. Methods The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work and recurrence. Both groups will be evaluated. Success rate of hernia repair and complications will be measured as safeguard for quality. To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP technique reduces postoperative pain to Discussion The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP technique, compared to Lichtenstein. In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein. Trial registration ISRCTN 93798494

  3. Systematic review and meta-analysis of published, randomized, controlled trials comparing suture anastomosis to stapled anastomosis for ileostomy closure.

    Science.gov (United States)

    Sajid, M S; Craciunas, L; Baig, M K; Sains, P

    2013-12-01

    The objective of this article is to systematically analyze the randomized, controlled trials comparing the effectiveness of suture anastomosis (SUA) versus stapled anastomosis (STA) in patients undergoing ileostomy closure. Randomized, controlled trials comparing the effectiveness of SUA versus STA in patients undergoing ileostomy closure were analyzed using RevMan(®), and combined outcomes were expressed as odds risk ratio (OR) and standardized mean difference (SMD). Four randomized, controlled trials that recruited 645 patients were retrieved from electronic databases. There were 327 patients in the STA group and 318 patients in the SUA group. There was significant heterogeneity among included trials. Operative time (SMD -1.02; 95 % CI -1.89, -0.15; z = 2.29; p infection, reoperation and readmission were similar following STA and SUA in patients undergoing ileostomy closure. Length of hospital stay was also similar between STA and SUA groups. In ileostomy closure, STA was associated with shorter operative time and lower risk of postoperative small bowel obstruction. However, STA and SUA were similar in terms of anastomotic leak, surgical site infection, readmission, reoperations and length of hospital stay.

  4. Comparative study of outcome measures and analysis methods for traumatic brain injury trials.

    Science.gov (United States)

    Alali, Aziz S; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B; Temkin, Nancy R

    2015-04-15

    Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.

  5. Uterine sarcoma Part I—Uterine leiomyosarcoma: The Topic Advisory Group systematic review

    Directory of Open Access Journals (Sweden)

    Kuo-Chang Wen

    2016-08-01

    Full Text Available Uterine sarcomas account for 3–7% of all uterine cancers. Because of their rarity, unknown etiology, and highly divergent genetic aberration, there is a lack of consensus on risk factors for occurrence and predictive poor outcomes as well as optimal therapeutic choices. Tumor types according to the World Health Organization classification include leiomyosarcoma, endometrial stroma sarcoma, and undifferentiated sarcoma. Staging is done using the 2014 Federation International Gynecology and Obstetrics and 2010 American Joint Committee on Cancer tumor, lymph node, and metastases systems. Tumor grade can be classified based on the French Federation of Cancer Centers Sarcoma Group system or the Broder’s system that incorporates tumor differentiation, mitotic count, and tumor necrosis. This review is a series of articles discussing uterine sarcoma, and this is Part I, which focuses on one of the subtypes of uterine sarcomas—uterine leiomyosarcoma. The clinical characteristics, diagnosis, outcome, and recent advances are summarized in this article.

  6. Uterine Artery Embolization to Treat Uterine Adenomyosis with or without Uterine Leiomyomata: Results of Symptom Control and Health-Related Quality of Life 40 Months after Treatment

    International Nuclear Information System (INIS)

    Froeling, V.; Scheurig-Muenkler, C.; Hamm, B.; Kroencke, T. J.

    2012-01-01

    Purpose: To evaluate the clinical outcome for uterine adenomyosis with or without uterine leiomyomata 40 months after uterine artery embolization (UAE). Methods: Forty women aged 39–56 years (median 46 years) with symptomatic uterine adenomyosis and magnetic resonance imaging findings of uterine adenomyosis with or without combined uterine leiomyomata underwent UAE. Self-perceived changes in clinical symptoms were assessed, and residual symptom severity and health-related quality of life (HRQOL) after UAE were evaluated. Clinical failure was defined as no symptomatic improvement or second invasive therapy after UAE. Results were stratified by the extent of uterine adenomyosis at baseline magnetic resonance imaging. Results: Patients were followed for a median of 40 months (range 5–102 months). UAE led to symptomatic control after UAE in 29 (72.5%) of 40 patients while 11 women underwent hysterectomy (n = 10) or dilatation and curettage (n = 1) for therapy failure. No significant difference between women with pure uterine adenoymosis and women with uterine adenomyosis combined with uterine leiomyomata was observed. Best results were shown for UAE in uterine adenomyosis with uterine leiomyomata predominance as opposed to predominant uterine adenomyosis with minor fibroid disease (clinical failure 0% vs. 31.5%, P = 0.058). Throughout the study group, HRQOL score values increased and symptom severity scores decreased after UAE. Least improvement was noted for women with pure adenomyosis. Conclusions: UAE is clinically effective in the long term in most women with uterine adenomyosis. Symptomatic control and HRQOL were highest in patients with combined disease of uterine adenomyosis but leiomyomata predominance.

  7. Are 3D ultrasound and office hysteroscopy useful for the assessment of uterine cavity after late foetal loss?

    Science.gov (United States)

    Thellier, E; Levaillant, J-M; Pourcelot, A-G; Houllier, M; Fernandez, H; Capmas, P

    2018-05-01

    To assess the efficacy of office hysteroscopy and 3D ultrasound for the diagnostic of uterine anomalies after late foetal loss. This retrospective observational study took place in the gynaecologic unit of a teaching hospital from 2009 to 2014. Women with late foetal loss (<22 weeks of gestation) had an office hysteroscopy and 3D ultrasound within three months after delivery. The results of the ultrasound and hysteroscopy were recorded and compared. Eighty women were included with a mean age of 29.8 years (28.2-31.4). Forty-seven women had both hysteroscopy and 3D ultrasound, and a uterine cavity's anomaly (bicornuate uterus, T-Shape uterus and septate uterus) was found in ten women (21%) at 3D sonography and in 13 women (28%) at office hysteroscopy. Concordance between the two exams was very good with a kappa at 0.83. In three cases, a uterine cavity's anomaly was found at hysteroscopy whereas sonography was normal. Anomalies at ultrasound (uterine cavity's anomaly, myometrium anomaly or ovarian anomaly) were found in 27.6% of cases. Both 3D ultrasound and office hysteroscopy are useful for assessment of the uterine cavity after late foetal loss. The application of these two exams is important, as hysteroscopy is generally used for assessment of the uterine cavity and endometrium, while 3D ultrasound is generally used to identify the precise type of uterine malformation and for the examination of the myometrium and annexes. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

  8. A randomized controlled trial comparing split and subunit influenza vaccines in adults in Colombia

    Directory of Open Access Journals (Sweden)

    A. Morales

    2003-06-01

    Full Text Available In a two-center, comparative trial, 344 adults were randomly assigned to receive a single dose of inactivated split-virion (Imovax Gripeâ or sub-unit (Agrippal S1â influenza vaccine (1999-2000 formulations. For analysis, study groups were subdivided into adult (18-60 years old and elderly (over 60 years subjects. Blood was drawn immediately before and one month after vaccination, safety was evaluated using a blind-observer design based on reporting of solicited and unsolicited adverse events. Both vaccines were very well tolerated, had similar reactogenicity profiles, and elicited fewer reports of reactions in elderly individuals. Post-vaccination Imovax Gripeâ induced seroprotective antibody titers against the three vaccine strains in 94-99% of adults and 88-97% of elderly subjects, compared with 88-100% and 88-98%, respectively, of those given Agrippal S1â. In conclusion, the split-virion and sub-unit influenza vaccines had similar safety and reactogenicity profiles, and elicited satisfactory immunity in adult and elderly subjects. However, higher post-vaccination geometric mean titer (GMT values in response to the B strain were seen with the split vaccine Imovax Gripeâ, giving it a better overall immunogenicity.En un ensayo comparativo realizado en dos centros, se asignaron de manera aleatoria 344 adultos para recibir una dosis de vacuna contra la gripe de virus fraccionado inactivado (Imovax Gripeâ o de vacuna de subunidades (Agrippal S1â (formulaciones 1999-2000. Para el análisis, los grupos estudiados fueron subdivididos en adultos (18-60 años y ancianos (más de 60 años. La sangre fue extraída justo antes y un mes después de la vacunación. La inocuidad fue evaluada utilizando un informe sobre reacciones adversas, usando un diseño de observador a ciegas. Ambas vacunas fueron muy bien toleradas, con perfiles de reactogenicidad similares y desarrollaron escasas reacciones adversas en los individuos ancianos. La vacunación con

  9. Abnormal Uterine Bleeding- evaluation by Endometrial Aspiration.

    Science.gov (United States)

    Singh, Pratibha

    2018-01-01

    Endometrial evaluation is generally indicated in cases presenting with abnormal uterine bleeding (AUB), especially in women more than 35 years of age. AUB encompasses a variety of presentation, for example, heavy menstrual bleeding, frequent bleeding, irregular vaginal bleeding, postcoital and postmenopausal bleeding to name a few. Many methods are used for the evaluation of such cases, with most common being sonography and endometrial biopsy with very few cases requiring more invasive approach like hysteroscopy. Endometrial aspiration is a simple and safe office procedure used for this purpose. We retrospectively analyzed cases of AUB where endometrial aspiration with Pipette (Medgyn) was done in outpatient department between January 2015 and April 2016. Case records (both paper and electronic) were used to retrieve data. One hundred and fifteen cases were included in the study after applying inclusion and exclusion criteria. Most cases were between 46 and 50 years of age followed by 41-45 years. No cases were below 25 or more than 65 years of age. Heavy menstrual bleeding was the most common presentation of AUB. Adequate samples were obtained in 86% of cases while 13.9% of cases' sample was inadequate for opinion, many of which were later underwent hysteroscopy and/or dilatation and curettage (D and C) in operation theater; atrophic endometrium was the most common cause for inadequate sample. Uterine malignancy was diagnosed in three cases. Endometrial aspiration has been compared with traditional D and C as well as postoperative histopathology in various studies with good results. Many such studies are done in India as well as in western countries confirming good correlation with histopathology and adequate tissue sample for the pathologist to give a confident diagnosis. No complication or side effect was noted with the use of this device. Endometrial aspiration is a simple, safe, and effective method to sample endometrium in cases of AUB avoiding risk of

  10. Abnormal Uterine Bleeding- evaluation by Endometrial Aspiration

    Directory of Open Access Journals (Sweden)

    Pratibha Singh

    2018-01-01

    Full Text Available Endometrial evaluation is generally indicated in cases presenting with abnormal uterine bleeding (AUB, especially in women more than 35 years of age. AUB encompasses a variety of presentation, for example, heavy menstrual bleeding, frequent bleeding, irregular vaginal bleeding, postcoital and postmenopausal bleeding to name a few. Many methods are used for the evaluation of such cases, with most common being sonography and endometrial biopsy with very few cases requiring more invasive approach like hysteroscopy. Endometrial aspiration is a simple and safe office procedure used for this purpose. Materials and Methods: We retrospectively analyzed cases of AUB where endometrial aspiration with Pipette (Medgyn was done in outpatient department between January 2015 and April 2016. Case records (both paper and electronic were used to retrieve data. Results: One hundred and fifteen cases were included in the study after applying inclusion and exclusion criteria. Most cases were between 46 and 50 years of age followed by 41–45 years. No cases were below 25 or more than 65 years of age. Heavy menstrual bleeding was the most common presentation of AUB. Adequate samples were obtained in 86% of cases while 13.9% of cases' sample was inadequate for opinion, many of which were later underwent hysteroscopy and/or dilatation and curettage (D and C in operation theater; atrophic endometrium was the most common cause for inadequate sample. Uterine malignancy was diagnosed in three cases. Discussion: Endometrial aspiration has been compared with traditional D and C as well as postoperative histopathology in various studies with good results. Many such studies are done in India as well as in western countries confirming good correlation with histopathology and adequate tissue sample for the pathologist to give a confident diagnosis. No complication or side effect was noted with the use of this device. Conclusion: Endometrial aspiration is a simple, safe, and

  11. Clinical application of uterine artery embolization in treating uterine scar pregnancy

    International Nuclear Information System (INIS)

    Li Tonghuai; Zheng Hongfeng

    2011-01-01

    Objective: To evaluate uterine artery embolization in treating uterine scar pregnancy. Methods: During the period from November 2007 to February 2010, 11 patients with uterine scar pregnancy were encountered in authors' hospital. All the patients had a history of lower uterine segment cesarean section. Four patients had to receive an emergency uterine artery embolization due to acute massive vaginal bleeding. The other 7 patients received intravenous chemotherapy with MTX (0.4 mg/kg/day, every 5 days as a treatment course). Emergency uterine artery embolization had to be carried out in three patients as they developed acute massive vaginal bleeding (blood loss ≥ 100 ml/hour) during the course of chemotherapy, while subsequent uterine artery embolization was performed in the remaining 4 patients after they had completed two courses of treatment when their blood HCG showed no significant decrease. The clinical results were analyzed. Results: Remarkable decrease in serum HCG was seen in all 11 patients after interventional management. The vaginal bleeding in 7 patients was significantly reduced within half an hour after uterine artery embolization. The uterus together with intact fertility was successfully preserved in all 11 patients. Conclusion: For the treatment of uterine scar pregnancy complicated by massive vaginal bleeding (blood loss ≥ 500 ml/24 h) and/or abnormal elevation of serum HCG (blood β-HCG ≥ 20000 IU/L), ectopic pregnancy with the mass diameter ≥ 5 cm, uterine artery embolization treatment is very safe and effective. This technique can well preserve female patient's uterus and fertility ability. It is of value to employ this treatment in clinical practice. (authors)

  12. Is a comparative clinical trial for breast cancer tumor markers to monitor disease recurrence warranted? A value of information analysis.

    Science.gov (United States)

    Thariani, Rahber; Henry, Norah Lynn; Ramsey, Scott D; Blough, David K; Barlow, Bill; Gralow, Julie R; Veenstra, David L

    2013-05-01

    Breast cancer tumor markers are used by some clinicians to screen for disease recurrence risk. Since there is limited evidence of benefit, additional research may be warranted. To assess the potential value of a randomized clinical trial of breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors. We developed a decision-analytic model of tumor marker testing plus standard surveillance every 3-6 months for 5 years. The expected value of sample information was calculated using probabilistic simulations and was a function of: the probability of selecting the optimal monitoring strategy with current versus future information; the impact of choosing the nonoptimal strategy; and the size of the population affected. The value of information for a randomized clinical trial involving 9000 women was US$214 million compared with a cost of US$30-60 million to conduct such a trial. The probability of making an alternate, nonoptimal decision and choosing testing versus no testing was 32% with current versus future information from the trial. The impact of a nonoptimal decision was US$2150 and size of population impacted over 10 years was 308,000. The value of improved information on overall survival was US$105 million, quality of life US$37 million and test performance US$71 million. Conducting a randomized clinical trial of breast cancer tumor markers appears to offer a good societal return on investment. Retrospective analyses to assess test performance and evaluation of patient quality of life using tumor markers may also offer valuable areas of research. However, alternative investments may offer even better returns in investments and, as such, the trial concept deserves further study as part of an overall research-portfolio evaluation.

  13. Adenocarcinoma of the Uterine Cervix

    International Nuclear Information System (INIS)

    Chung, Eun Ji; Shin, Hyun Soo; Lee, Hyung Sik; Kim, Gwi Eon; Loh, Juhn Kyu; Suh, Chang Ok

    1991-01-01

    Survival data, prognostic factors, and patterns of failure were retrospectively analyzed for a total of 76 patients with adenocarcinoma of the uterine cervix treated between January 1981 and December 1987, which represents 4.1% of all primary cervical carcinomas treated, at Department of Radiation Oncology, Yensei Cancer Center, Yonsei University College of Medicine. The mean age of the patients was 49years(range, 27-79years) and the peak incidence was in the group 50 to 59years of age. More half of the patients were postmenopausal (46/76=60.5%). Most patients(76%)had abnormal vaginal bleeding either alone or in combination with other symptoms. The proportion of stage Iib was 43.4%. There were 4 major histologic subtypes: pure adenocarcinoma(48/76=63.2%), adenosquamous carcinoma(20/76=26.3%), papillary (5/76=6.6%) and clear cell carcinoma(3/76=3.9%). Of the many clinicopathologic variables evaluated for prognosis, the most significant prognostic factors were stage of disease and the size of tumor. The overall 5-year survival rate was 68%, and the 5-year survival rates for stage Ib, II and III were 90%, 66% and 54%, respectively. Control of pelvic tumors was achieved in 938%, 90.2% and 50.0% of cases of stage Ib, II and III disease, respectively. In present study, treatment modalities (radiation therapy alone/combined operative and radiation therapy) did not affect the local control of tumor and the survival

  14. Adenocarcinoma of the Uterine Cervix

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Eun Ji; Shin, Hyun Soo; Lee, Hyung Sik; Kim, Gwi Eon; Loh, Juhn Kyu; Suh, Chang Ok [Yonsei University College of Medicine, Seoul (Korea, Republic of)

    1991-12-15

    Survival data, prognostic factors, and patterns of failure were retrospectively analyzed for a total of 76 patients with adenocarcinoma of the uterine cervix treated between January 1981 and December 1987, which represents 4.1% of all primary cervical carcinomas treated, at Department of Radiation Oncology, Yensei Cancer Center, Yonsei University College of Medicine. The mean age of the patients was 49years(range, 27-79years) and the peak incidence was in the group 50 to 59years of age. More half of the patients were postmenopausal (46/76=60.5%). Most patients(76%)had abnormal vaginal bleeding either alone or in combination with other symptoms. The proportion of stage Iib was 43.4%. There were 4 major histologic subtypes: pure adenocarcinoma(48/76=63.2%), adenosquamous carcinoma(20/76=26.3%), papillary (5/76=6.6%) and clear cell carcinoma(3/76=3.9%). Of the many clinicopathologic variables evaluated for prognosis, the most significant prognostic factors were stage of disease and the size of tumor. The overall 5-year survival rate was 68%, and the 5-year survival rates for stage Ib, II and III were 90%, 66% and 54%, respectively. Control of pelvic tumors was achieved in 938%, 90.2% and 50.0% of cases of stage Ib, II and III disease, respectively. In present study, treatment modalities (radiation therapy alone/combined operative and radiation therapy) did not affect the local control of tumor and the survival.

  15. Intra-uterine contraceptive devices.

    Science.gov (United States)

    Elias, J

    1985-05-01

    Among the advantages of IUDs are the device's high continuation rate, the lack of systemic side effects, and the absence of a need for continual motivation to practice contraception. The effectiveness of plastic IUDs is directly proportional to their surface area, but the degree of excessive bleeding experienced is inversely related to device size. Thus, devices represent a compromise between large size for effectiveness and small size for acceptability. The optimum time to fit an IUD is during the 1st hald of the menstrual cycle. Absolute contraindications to IUD use include the presence of active pelvic inflammatory disease, undiagnosed irregular bleeding, a history of ectopic pregnancy or tubal surgery, and a distorted uteine cavity. Failure rates associated with IUD use range from 2-3% in the 1st year and then decrease. Since the main mechanism of action appears to be production of a sterile inflammatory reaction in the uterine cavity, the IUD prevents intrauterine pregnancy more effectively than ectopic pregnancy. Nonetheless, there is little evidence to suggest that IUD use actually increases the incidence of ectopic pregnancy. Resumption of fertility after IUD removal is not delayed. There is not need to change inert plastic IUDs in women who remain symptom free. The copper devices should be changed every 3-4 years. A search is under way for antifertility agents that can be incorporated into the device to reduce side effects. In general, the IUD is most suitable for older, parous women.

  16. Postpartum perineal reapir performed by midwives: A randomised trial comparing two suture techniques for perineal repair leaving the skin unsutured

    DEFF Research Database (Denmark)

    Kindberg, Sara; Misan, Stehouwer; Hvidman, Lone

    2008-01-01

    Postpartum perineal repair performed by midwives: A randomised trial comparing two suture techniques leaving the skin unsutured. Objective      To compare a continuous suture technique to interrupted stitches using inverted knots for postpartum perineal repair of second-degree lacerations...... and episiotomies.   Design          A double blind randomised controlled trial.   Setting          A Danish university hospital with more than 4800 deliveries annually.   Population   400 healthy primiparous women with a vaginal delivery at term.   Method         Randomisation was computer-controlled. Structured...... healing, patient satisfaction, dyspareunia or need for resuturing. The continuous suture technique was significantly faster (15 min. vs. 17 min, p=0.03) and less suture material was used (1 vs. 2 packets, pskin unsutured...

  17. Informed consent from cognitively impaired persons participating in research trials: comparative law observations.

    Science.gov (United States)

    Petrini, Carlo

    2011-01-01

    This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  18. Treatment of secondary hyperparathyroidism in haemodialysis patients: a randomised clinical trial comparing paricalcitol and alfacalcidol

    DEFF Research Database (Denmark)

    Hansen, Ditte; Brandi, Lisbet; Rasmussen, Knud

    2009-01-01

    BACKGROUND: Secondary hyperparathyroidism is a common feature in patients with chronic kidney disease. Its serious clinical consequences include renal osteodystrophy, calcific uremic arteriolopathy, and vascular calcifications that increase morbidity and mortality.Reduced synthesis of active vita...... in the risk of cardiovascular mortality depending on which vitamin D analog that are used. This has potential major importance for this group of patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT00469599....... vitamin D contributes to secondary hyperparathyroidism. Therefore, this condition is managed with activated vitamin D. However, hypercalcemia and hyperphosphatemia limit the use of activated vitamin D.In Denmark alfacalcidol is the primary choice of vitamin D analog.A new vitamin D analog, paricalcitol...... and hyperphosphatemia are associated with increased cardiovascular mortality in patients with chronic kidney disease.If there is any difference in the ability of these two vitamin D analogs to decrease the secondary hyperparathyroidism without causing hypercalcemia and hyperphosphatemia, there may also be a difference...

  19. Informed consent from cognitively impaired persons participating in research trials: comparative law observations

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2011-12-01

    Full Text Available This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  20. Reducing Trunk Compensation in Stroke Survivors: A Randomized Crossover Trial Comparing Visual and Force Feedback Modalities.

    Science.gov (United States)

    Valdés, Bulmaro Adolfo; Schneider, Andrea Nicole; Van der Loos, H F Machiel

    2017-10-01

    To investigate whether the compensatory trunk movements of stroke survivors observed during reaching tasks can be decreased by force and visual feedback, and to examine whether one of these feedback modalities is more efficacious than the other in reducing this compensatory tendency. Randomized crossover trial. University research laboratory. Community-dwelling older adults (N=15; 5 women; mean age, 64±11y) with hemiplegia from nontraumatic hemorrhagic or ischemic stroke (>3mo poststroke), recruited from stroke recovery groups, the research group's website, and the community. In a single session, participants received augmented feedback about their trunk compensation during a bimanual reaching task. Visual feedback (60 trials) was delivered through a computer monitor, and force feedback (60 trials) was delivered through 2 robotic devices. Primary outcome measure included change in anterior trunk displacement measured by motion tracking camera. Secondary outcomes included trunk rotation, index of curvature (measure of straightness of hands' path toward target), root mean square error of hands' movement (differences between hand position on every iteration of the program), completion time for each trial, and posttest questionnaire to evaluate users' experience and system's usability. Both visual (-45.6% [45.8 SD] change from baseline, P=.004) and force (-41.1% [46.1 SD], P=.004) feedback were effective in reducing trunk compensation. Scores on secondary outcome measures did not improve with either feedback modality. Neither feedback condition was superior. Visual and force feedback show promise as 2 modalities that could be used to decrease trunk compensation in stroke survivors during reaching tasks. It remains to be established which one of these 2 feedback modalities is more efficacious than the other as a cue to reduce compensatory trunk movement. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  1. A proposed framework for evaluating and comparing efficacy estimates in clinical trials of new rotavirus vaccines.

    Science.gov (United States)

    Neuzil, Kathleen M; Zaman, K; Victor, John C

    2014-08-11

    Oral rotavirus vaccines have yielded different point estimates of efficacy when tested in different populations. While population and environmental factors may account for these differences, study design characteristics should also be considered. We review the study design elements of rotavirus vaccine trials that may affect point estimates of efficacy, and propose a framework for evaluating new rotavirus vaccines. Copyright © 2014. Published by Elsevier Ltd.

  2. Premenopausal abnormal uterine bleeding and risk of endometrial cancer.

    Science.gov (United States)

    Pennant, M E; Mehta, R; Moody, P; Hackett, G; Prentice, A; Sharp, S J; Lakshman, R

    2017-02-01

    Endometrial biopsies are undertaken in premenopausal women with abnormal uterine bleeding but the risk of endometrial cancer or atypical hyperplasia is unclear. To conduct a systematic literature review to establish the risk of endometrial cancer and atypical hyperplasia in premenopausal women with abnormal uterine bleeding. Search of PubMed, Embase and the Cochrane Library from database inception to August 2015. Studies reporting rates of endometrial cancer and/or atypical hyperplasia in women with premenopausal abnormal uterine bleeding. Data were independently extracted by two reviewers and cross-checked. For each outcome, the risk and a 95% CI were estimated using logistic regression with robust standard errors to account for clustering by study. Sixty-five articles contributed to the analysis. Risk of endometrial cancer was 0.33% (95% CI 0.23-0.48%, n = 29 059; 97 cases) and risk of endometrial cancer or atypical hyperplasia was 1.31% (95% CI 0.96-1.80, n = 15 772; 207 cases). Risk of endometrial cancer was lower in women with heavy menstrual bleeding (HMB) (0.11%, 95% CI 0.04-0.32%, n = 8352; 9 cases) compared with inter-menstrual bleeding (IMB) (0.52%, 95% CI 0.23-1.16%, n = 3109; 14 cases). Of five studies reporting the rate of atypical hyperplasia in women with HMB, none identified any cases. The risk of endometrial cancer or atypical hyperplasia in premenopausal women with abnormal uterine bleeding is low. Premenopausal women with abnormal uterine bleeding should first undergo conventional medical management. Where this fails, the presence of IMB and older age may be indicators for further investigation. Further research into the risks associated with age and the cumulative risk of co-morbidities is needed. Contrary to practice, premenopausal women with heavy periods or inter-menstrual bleeding rarely require biopsy. © 2016 The Authors BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal

  3. Multiple primary tumors in patients with uterine cancer

    International Nuclear Information System (INIS)

    Velikova, N.; Parvanova, V.; Dimitrova, N.

    2013-01-01

    Full text: Introduction: The aging population and improved medical care lead to increased likelihood for patients experienced a tumor to develop at least one more in the course of his life. The aim of the study was to analyze the clinical and biological characteristics and survival of patients with primary tumor multiplicity in which a tumor is cancer of the uterine body. Materials and Methods: For the period 1997-2007, in the department of radiotherapy were treated 191 women with carcinoma of the uterine body (in a group of moderate and high risk) with invasion of the myometrium more than one third. Patients ranged in age from 36 to 77 (average age 59.9) and were followed until 31.03.2013 with an average follow-up period 126 months. Postoperatively, all were carried intravaginal brachytherapy with high dose rate 3x5 Gy once a week, followed by percutaneous radiotherapy 22x2 Gy daily to the area of the pelvic lymph nodes. Data to diagnose combined tumors were obtained from the National Cancer Registry. Survival analysis was made by the method of Kaplan - Meier with Lograng test. Results: In 26 (13.6 %) of the analyzed patients a tumor multiplicity is find in 22 (84,6%) tumors are two in 3 (11.5 %)- three , and in 1 (3.8%) - four . A detailed analysis of 14 (53.8%) patients whose cancer of the uterine body is the first tumor and is followed by another. The distribution of the tumor according to the second location is: breast cancer 5 (35.7%) skin malignant melanoma without 4 (28.5%) of the column 3 (21.4 %) of stomach 1 (7.1%) , MALT lymphoma, 1 (7.1% ) . Evaluate and compare the 5 - and 10-year overall survival of patients whose cancer of the uterine body only, and those who are diagnosed with a malignant tumor following - in those without a second tumor is 85.3% and 81.4 %, and in the presence of such a - 78, 6% and 69.3% respectively. Conclusion: The matched tumors are the most common among the so-called hormone dependent cancers such as breast cancer, uterine

  4. Single-Staged Compared With Multi-Staged PCI in Multivessel NSTEMI Patients: The SMILE Trial.

    Science.gov (United States)

    Sardella, Gennaro; Lucisano, Luigi; Garbo, Roberto; Pennacchi, Mauro; Cavallo, Erika; Stio, Rocco Edoardo; Calcagno, Simone; Ugo, Fabrizio; Boccuzzi, Giacomo; Fedele, Francesco; Mancone, Massimo

    2016-01-26

    A lack of clarity exists about the role of complete coronary revascularization in patients presenting with non-ST-segment elevation myocardial infarction. The aim of our study was to compare long-term outcomes in terms of major adverse cardiovascular and cerebrovascular events of 2 different complete coronary revascularization strategies in patients with non-ST-segment elevation myocardial infarction and multivessel coronary artery disease: 1-stage percutaneous coronary intervention (1S-PCI) during the index procedure versus multistage percutaneous coronary intervention (MS-PCI) complete coronary revascularization during the index hospitalization. In the SMILE (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention) trial, 584 patients were randomly assigned in a 1:1 manner to 1S-PCI or MS-PCI. The primary study endpoint was the incidence of major adverse cardiovascular and cerebrovascular events, which were defined as cardiac death, death, reinfarction, rehospitalization for unstable angina, repeat coronary revascularization (target vessel revascularization), and stroke at 1 year. The occurrence of the primary endpoint was significantly lower in the 1-stage group (1S-PCI: n = 36 [13.63%] vs. MS-PCI: n = 61 [23.19%]; hazard ratio [HR]: 0.549 [95% confidence interval (CI): 0.363 to 0.828]; p = 0.004). The 1-year rate of target vessel revascularization was significantly higher in the MS-PCI group (1S-PCI: n = 22 [8.33%] vs. MS-PCI: n = 40 [15.20%]; HR: 0.522 [95% CI: 0.310 to 0.878]; p = 0.01; p log-rank = 0.013). When the analyses were limited to cardiac death (1S-PCI: n = 9 [3.41%] vs. MS-PCI: n = 14 [5.32%]; HR: 0.624 [95% CI: 0.270 to 1.441]; p = 0.27) and myocardial infarction (1S-PCI: n = 7 [2.65%] vs. MS-PCI: n = 10 [3.80%]; HR: 0.678 [95% CI: 0.156 to 2.657]; p = 0.46), no significant differences were observed between groups. In multivessel

  5. A combination of subcuticular suture and sterile Micropore tape compared with conventional interrupted sutures for skin closure. A controlled trial.

    Science.gov (United States)

    Taube, M.; Porter, R. J.; Lord, P. H.

    1983-01-01

    We have conducted a controlled trial to compare skin closure using conventional interrupted sutures with a combination of subcuticular suture and sterile Micropore tape in 169 patients undergoing appendicectomy, inguinal herniorrhaphy, or saphenofemoral ligation. We have found that the combination technique consistently gives a better cosmetic result and that the tape acts well as a dressing, is convenient, and is well tolerated by patients. Images Fig. 1 Fig. 2 Fig. 3 Fig. 4 PMID:6344732

  6. Cytofluorophotometrical study of the DNA content of the uterine cervical carcinoma and the vaginal epithelium

    International Nuclear Information System (INIS)

    Tokumoto, Yoshiaki

    1987-01-01

    The Feulgen DNA content in cells of uterine cervical carcinoma and that of its adjacent vaginal epithelium were measured by microfluorophotometry. The Feulgen DNA content in cells of uterine cervical carcinoma was increased and showed a greater variation of its DNA values compared with diploid cells. The Feulgen DNA content in cells of normal vaginal epithelium adjacent to cervical carcinoma was also increased compared with diploid cells in 6 out of 8 cases. The relativity between the cellular DNA content of cervical carcinoma and that of its adjacent normal vaginal epithelium was found. In 10 out of 14 cases of uterine cervical carcinoma, the mean value of cellular DNA content was increased after by therapuetic irradiation with 10 Gy. Radiation effects on the DNA content of vaginal epithelial cells were similar to those on the DNA content of carcinoma cells. (author)

  7. Quantitative comparison between treatment results for uterine cervix cancer by radiation therapy and surgery

    International Nuclear Information System (INIS)

    Iinuma, Takeshi; Fukuhisa, Kenjiro; Arai, Tatsuo

    1983-01-01

    Treatment results for uterine cervix cancer were evaluated using a new concept named ''Effective Survival Rate''. This rate was calculated by subtracting the weighted sum of incidence rates of various complications from the 5-year survival rate. The numerical values for various complications were assigned as follows: surgical death, 1.0; severe complications, such as fistula ureterovaginalis and ileus, 0.5; mild complications, such as rectum and urinary bladder complications, 0.3 and 0.2. These values were determined with reference to the Karnofsky index of performance status. The effective survival rate was calculated for patients with satage 2 and 3 uterine cervix cancer treated by radiation therapy and surgery, and compared as a function of age between 30 and 70 years. We concluded that the effective survival rate was comparable for radiation therapy and surgery for stage 2 uterine cervix cancer. However, in patients with stage 3, radiation therapy was superior. (author)

  8. A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wang, Chenchen; McAlindon, Timothy; Fielding, Roger A; Harvey, William F; Driban, Jeffrey B; Price, Lori Lyn; Kalish, Robert; Schmid, Anna; Scott, Tammy M; Schmid, Christopher H

    2015-01-30

    Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial. A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ≥21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up. This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short

  9. Uterine biology in pigs and sheep

    Directory of Open Access Journals (Sweden)

    Bazer Fuller W

    2012-07-01

    Full Text Available Abstract There is a dialogue between the developing conceptus (embryo-fetus and associated placental membranes and maternal uterus which must be established during the peri-implantation period for pregnancy recognition signaling, implantation, regulation of gene expression by uterine epithelial and stromal cells, placentation and exchange of nutrients and gases. The uterus provide a microenvironment in which molecules secreted by uterine epithelia or transported into the uterine lumen represent histotroph required for growth and development of the conceptus and receptivity of the uterus to implantation. Pregnancy recognition signaling mechanisms sustain the functional lifespan of the corpora lutea (CL which produce progesterone, the hormone of pregnancy essential for uterine functions that support implantation and placentation required for a successful outcome of pregnancy. It is within the peri-implantation period that most embryonic deaths occur due to deficiencies attributed to uterine functions or failure of the conceptus to develop appropriately, signal pregnancy recognition and/or undergo implantation and placentation. With proper placentation, the fetal fluids and fetal membranes each have unique functions to ensure hematotrophic and histotrophic nutrition in support of growth and development of the fetus. The endocrine status of the pregnant female and her nutritional status are critical for successful establishment and maintenance of pregnancy. This review addresses the complexity of key mechanisms that are characteristic of successful reproduction in sheep and pigs and gaps in knowledge that must be the subject of research in order to enhance fertility and reproductive health of livestock species.

  10. Uterine artery embolization for adenomyosis without fibroids

    Energy Technology Data Exchange (ETDEWEB)

    Kim, M.D. E-mail: mdkim@cha.ac.kr; Won, J.W.; Lee, D.Y.; Ahn, C.-S

    2004-06-01

    AIM: To evaluate the potential usefulness of transcatheter uterine artery embolization as a treatment for symptomatic adenomyosis in patients without uterine fibroids. MATERIALS AND METHODS: Uterine artery embolization using polyvinyl alcohol particles sized 250-710 mm was performed in 43 patients (mean; 40.3 years, range; 31-52 years) with dysmenorrhoea, menorrhagia, or bulk-related symptoms (pelvic heaviness, urinary frequency) due to adenomyosis without fibroids. All patients underwent pre-procedural and 3.5 months (range 1-8 months) follow-up magnetic resonance imaging (MRI) with contrast enhancement. Clinical symptoms were also assessed at the time of MRI before and after embolization. RESULTS: Significant improvement of dysmenorrhoea (95.2%) and menorrhagia (95.0%) was reported in most patients. Contrast-enhanced MRI revealed non-enhancing areas suggesting coagulation necrosis of adenomyosis in 31 patients (72.1%), decreased size without necrosis in 11 patients (25.6%), and no change in one patient (2.3%). The mean volume reduction of the uteri after uterine artery embolization was 32.5% (from 321.7{+-}142.9 to 216.7{+-}130.1 cm{sup 3}). CONCLUSION: Transcatheter uterine artery embolization is an effective therapy for the treatment of symptomatic pure adenomyosis, and may be a valuable alternative to hysterectomy.

  11. Uterine artery embolization for adenomyosis without fibroids

    International Nuclear Information System (INIS)

    Kim, M.D.; Won, J.W.; Lee, D.Y.; Ahn, C.-S.

    2004-01-01

    AIM: To evaluate the potential usefulness of transcatheter uterine artery embolization as a treatment for symptomatic adenomyosis in patients without uterine fibroids. MATERIALS AND METHODS: Uterine artery embolization using polyvinyl alcohol particles sized 250-710 mm was performed in 43 patients (mean; 40.3 years, range; 31-52 years) with dysmenorrhoea, menorrhagia, or bulk-related symptoms (pelvic heaviness, urinary frequency) due to adenomyosis without fibroids. All patients underwent pre-procedural and 3.5 months (range 1-8 months) follow-up magnetic resonance imaging (MRI) with contrast enhancement. Clinical symptoms were also assessed at the time of MRI before and after embolization. RESULTS: Significant improvement of dysmenorrhoea (95.2%) and menorrhagia (95.0%) was reported in most patients. Contrast-enhanced MRI revealed non-enhancing areas suggesting coagulation necrosis of adenomyosis in 31 patients (72.1%), decreased size without necrosis in 11 patients (25.6%), and no change in one patient (2.3%). The mean volume reduction of the uteri after uterine artery embolization was 32.5% (from 321.7±142.9 to 216.7±130.1 cm 3 ). CONCLUSION: Transcatheter uterine artery embolization is an effective therapy for the treatment of symptomatic pure adenomyosis, and may be a valuable alternative to hysterectomy

  12. Can Intrapartum Cardiotocography Predict Uterine Rupture among Women with Prior Caesarean Delivery?

    DEFF Research Database (Denmark)

    Andersen, Malene; Thisted, Dorthe L A; Amer-Wåhlin, Isis

    2016-01-01

    and available CTG. The CTG tracings were assessed by 19 independent experts divided into groups of three different experts for each tracing. The assessors were blinded to group, outcome and clinical data. They analyzed occurrence of defined abnormalities and classified the traces as normal, suspicious...... attention on threatening uterine rupture but cannot be considered a strong predictor as it is common in all women with trial of labour after caesarean delivery....

  13. Umbilical cord mesenchyme stem cell local intramuscular injection for treatment of uterine niche

    OpenAIRE

    Fan, Dazhi; Wu, Shuzhen; Ye, Shaoxin; Wang, Wen; Guo, Xiaoling; Liu, Zhengping

    2017-01-01

    Abstract Background: Uterine niche is defined as a triangular anechoic structure at the site of the scar or a gap in the myometrium at the site of a previous caesarean section. The main clinical manifestations are postmenstrual spotting and intrauterine infection, which may seriously affect the daily life of nonpregnant women. Trials have shown an excellent safety and efficacy for the potential of mesenchymal stem cells (MSCs) as a therapeutic option for scar reconstruction. Therefore, this s...

  14. Effects of fetal hypothyroidism on uterine smooth muscle contraction and structure of offspring rats.

    Science.gov (United States)

    Bagheripuor, Fatemeh; Ghanbari, Mahboubeh; Piryaei, Abbas; Ghasemi, Asghar

    2018-05-01

    What is the central question of this study? Does fetal hypothyroidism in rats alter uterine contractions and structure in the adult offspring? What is the main finding and its importance? Our study indicated that maternal hypothyroidism during pregnancy increased gestational length and decreased litter size. In addition, maternal hypothyroidism caused delayed puberty onset, irregular uterine contractions and histological changes in the uterus in the female offspring. This model might contribute to a better understanding of the cellular and molecular mechanisms involved in uterine contractions in fetal hypothyroidism, studies which are not possible in humans, and might help to establish therapeutic methods for these disorders observed in uterine contractions. Thyroid hormones play an essential role in fetal growth. Hypothyroidism impairs reproductive function in both humans and animals. The aim of this study was to assess the effects of fetal hypothyroidism on uterine smooth muscle contraction and structure in the adult offspring. The control group of female Wistar rats consumed tap water, whereas the hypothyroid group received water containing 0.025% of 6-propyl-2-thiouracial throughout gestation from mating until delivery. Isometric contractility and histological changes in uterine tissue were evaluated in the adult female offspring. We tested the effects of carbachol (10 -10 -10 -3  m) and oxytocin (10 -13 -10 -8  m) on uterine smooth muscle contraction in the fetal hypothyroid (FH) and control groups. Compared with control uteri, carbachol induced contractions with lower amplitude in the FH group (area under the curve: 1820.0 ± 250.0 versus 1370.0 ± 125.0 a.u., control versus FH group, respectively, P muscle layer and the cross-sectional area of the uterus were also significantly lower in the FH group. Gestational length was longer and litter size smaller in FH rats compared with control animals; FH offspring also had delayed puberty. In conclusion

  15. Degenerated uterine leiomyomas mimicking malignant bilateral ovarian surface epithelial tumors

    Energy Technology Data Exchange (ETDEWEB)

    Hwang, Yi Boem Ha; Lee, Hae Kyung; Lee, Min Hee; Choi, Seo Youn; Chung, Soo Ho [Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon (Korea, Republic of)

    2017-07-15

    Uterine leiomyomas are the most common benign uterine neoplasms. Undegenerated uterine leiomyomas are easily recognizable by the typical imaging findings on radiologic studies. However, degenerated fibroids can have unusual and variable appearances. The atypical appearances due to degenerative changes may cause confusion in diagnosis of leiomyomas. In this article, we report a case of a patient with extensive cystic and myxoid degeneration of uterine leiomyoma, mimicking malignant bilateral ovarian surface epithelial tumors.

  16. Selective uterine artery embolization: its application in treating symptomatic uterine leiomyomas

    International Nuclear Information System (INIS)

    Zhang Guofu; Han Zhigang; Hu Pei'an; Wang Shijia; Tian Xiaomei; Zhou Yan; He Beiyi; Wang Jing

    2010-01-01

    Objective: To discuss the feasibility and safety of uterine artery embolization(UAE) for the treatment of symptomatic uterine leiomyomas. Methods: During the period of Jan. 2005-June 2009, UAE was performed in 85 patients with uterine leiomyomas in the authors' hospital. The main symptoms included hypermenorrhea, delayed menstruation and pelvic pressure symptoms. The bilateral uterine arteries were embolized with polyvinyl alcohol particles (diameter 500-710 μm) and Gelfoam. The technical success rate and the clinical results were observed. The patients were followed up for 6-36 months. Results: The technical success rate of bilateral uterine artery embolization was 100%. No serious complications occurred. During the follow-up period, menses returned to regular cycle in all patients and the hemoglobin concentration rose up to normal level in patients with anemia. The sizes of uterine leiomyomas were decreased by 57.5% after 6 months of the procedure. Conclusion: UAE is an effective and less-invasive treatment for symptomatic uterine leiomyomas with reliable results and fewer complications. This technique can greatly avoid unnecessary uterectomy and, thus, preserve the fertility of the female patients.(authors)

  17. Uterine arterial methotrexate infusion and embolization in the treatment of uterine adenomyosis

    International Nuclear Information System (INIS)

    Xie Jingyan; Wang Suzheng; Chen Jingfang; Xuan Yinghua; Lou Wensheng; Gu Jianping

    2008-01-01

    Objective: To study the efficacy of treating different types of uterine adenomyosis with transcatheter local infusion of methotrexate (MTX) combined with uterine arterial embolization under guidance of digital subtraction angiography (DSA). Methods: 33 cases were primarily screened out according to clinical symptoms and color Doppler and then further diagnosis as diffuse or local adenomyosis were undertaken with super selective uterine arterial angiography. The patients were then treated with uterine arterial local infusion (50 mg MTX)and embolization with PVA microsphere (diameter 450-650 μm), individually. Finally, the comparison between the preoperative and postoperative menstruation volumes, the degrees of dysmenorrheal, uterine sizes and the levels of sexual hormones of diffuse and local adenomyosis was carried out. Results: The uterine arterial local infusion of MTX combined with embolization showed no chemotherapeutic side effects. In all cases, there were decrease of menstruation amount, alleviated dysmenorrhea, reduction of uterine size, and the efficacy was more evident in diffuse adenomyosis (P<0.05). Conclusions: Micro-invasive interventional technique combined with drug therapy is promising for diffuse and local adenomyosis especially for the former. (authors)

  18. Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study

    Science.gov (United States)

    MacLaughlan David, Shannon; Salzillo, Sandra; Bowe, Patrick; Scuncio, Sandra; Malit, Bridget; Raker, Christina; Gass, Jennifer S; Granai, C O; Dizon, Don S

    2013-01-01

    Objectives To compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors, and to evaluate the feasibility of conducting a clinical trial comparing a drug with a complementary or alternative method (CAM). Design Prospective randomised trial. Setting Breast health centre of a tertiary care centre. Participants 15 women with a personal history of breast cancer or an increased risk of breast cancer who reported at least one daily hot flash. Interventions Gabapentin 900 mg daily in three divided doses (control) compared with standardised hypnotherapy. Participation lasted 8 weeks. Outcome measures The primary endpoints were the number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was the Hot Flash Related Daily Interference Scale (HFRDIS). Results 27 women were randomised and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrolment was 4.5 in the gabapentin arm and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After 8 weeks, the median number of daily hot flashes was reduced by 33.3% in the gabapentin arm and by 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm and by 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and by 55.2% in the hypnotherapy group. There were no statistically significant differences between groups. Conclusions Hypnotherapy and gabapentin demonstrate efficacy in improving hot flashes. A definitive trial evaluating traditional interventions against CAM methods is feasible, but not without challenges. Further studies aimed at defining evidence-based recommendations for CAM are necessary. Trial registration clinicaltrials.gov (NCT00711529). PMID:24022390

  19. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...... analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal...

  20. A randomized trial comparing bladder volume consistency during fractionated prostate radiation therapy

    LENUS (Irish Health Repository)

    Mullaney, L.

    2014-01-10

    Organ motion is a contributory factor to the variation in location of the prostate and organs at risk during a course of fractionated prostate radiation therapy (RT). A prospective randomized controlled trial was designed with the primary endpoint to provide evidence-based bladder-filling instructions to achieve a consistent bladder volume (BV) and thus reduce the bladder-related organ motion. The secondary endpoints were to assess the incidence of acute and late genitourinary (GU) and gastrointestinal (GI) toxicity for patients and patients’ satisfaction with the bladder-filling instructions.

  1. Clinical value of real time 3D sonohysterography and 2D sonohysterography in comparison to hysteroscopy with subsequent histopathological examination in perimenopausal women with abnormal uterine bleeding.

    Science.gov (United States)

    Kowalczyk, Dariusz; Guzikowski, Wojciech; Więcek, Jacek; Sioma-Markowska, Urszula

    2012-01-01

    In many publications the transvaginal ultrasound is regarded as the first step to diagnose the cause of uterine bleeding in perimenopausal women. In order to improve the sensitivity and specificity of the conventional ultrasound physiological saline solution was administered to the uterine cavity and after expansion of its walls the interior uterine cavity was examined. And this procedure is called 2D sonohysterography (SIS 2D). By the ultrasound scanners which enable to get 3D real time image a spatial evaluation of the uterine cavity is possible. Clinical value of the real time 3D sonohysterography and 2D sonohysterography compared to hysteroscopy with histopathological examination in perimenopausal women. The study concerned a group of 97 perimenopausal women with abnormal uterine bleeding. In all of them after a standard transvaginal ultrasonography a catheter was inserted into the uterine cavity. After expansion of the uterine walls by administering about 10 ml of 0,9% saline solution the uterine cavity was examined by conventional sonohysterography. Then a 3D imaging mode was activated and the uterine interior was examined by real time 3D ultrasonography. The ultrasound results were verified by hysteroscopy, the endometrial lesions were removed and underwent a histopathological examination. In two cases the SIS examination was impossible because of uterine cervix atresion. In the rest of examined group the SIS 2D sensitivity and specificity came up to 72 and 96% respectively. In the group of SIS 3D the sensitivity and specificity reached 83 and 99% respectively. Adding SIS 3D, a minimally invasive method, to conventional sonohysterography improves the precision of diagnosis of endometrial pathology, allows to get three-dimensional image of the uterine cavity and enables examination of endometrial lesions. The diagnostic precision of this procedure is similar to the results achieved by hysteroscopy.

  2. Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis

    Science.gov (United States)

    Fysh, Edward T H; Thomas, Rajesh; Read, Catherine A; Lam, Ben C H; Yap, Elaine; Horwood, Fiona C; Lee, Pyng; Piccolo, Francesco; Shrestha, Ranjan; Garske, Luke A; Lam, David C L; Rosenstengel, Andrew; Bint, Michael; Murray, Kevin; Smith, Nicola A; Lee, Y C Gary

    2014-01-01

    Introduction Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients’ remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources. Methods and analysis The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores. Ethics and dissemination The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The

  3. A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

    2014-11-11

    Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions

  4. Genome-Wide DNA Methylation Indicates Silencing of Tumor Suppressor Genes in Uterine Leiomyoma

    Science.gov (United States)

    Navarro, Antonia; Yin, Ping; Monsivais, Diana; Lin, Simon M.; Du, Pan; Wei, Jian-Jun; Bulun, Serdar E.

    2012-01-01

    Background Uterine leiomyomas, or fibroids, represent the most common benign tumor of the female reproductive tract. Fibroids become symptomatic in 30% of all women and up to 70% of African American women of reproductive age. Epigenetic dysregulation of individual genes has been demonstrated in leiomyoma cells; however, the in vivo genome-wide distribution of such epigenetic abnormalities remains unknown. Principal Findings We characterized and compared genome-wide DNA methylation and mRNA expression profiles in uterine leiomyoma and matched adjacent normal myometrial tissues from 18 African American women. We found 55 genes with differential promoter methylation and concominant differences in mRNA expression in uterine leiomyoma versus normal myometrium. Eighty percent of the identified genes showed an inverse relationship between DNA methylation status and mRNA expression in uterine leiomyoma tissues, and the majority of genes (62%) displayed hypermethylation associated with gene silencing. We selected three genes, the known tumor suppressors KLF11, DLEC1, and KRT19 and verified promoter hypermethylation, mRNA repression and protein expression using bisulfite sequencing, real-time PCR and western blot. Incubation of primary leiomyoma smooth muscle cells with a DNA methyltransferase inhibitor restored KLF11, DLEC1 and KRT19 mRNA levels. Conclusions These results suggest a possible functional role of promoter DNA methylation-mediated gene silencing in the pathogenesis of uterine leiomyoma in African American women. PMID:22428009

  5. Polymorphism of the p53 tumor suppressor gene is associated with susceptibility to uterine leiomyoma.

    Science.gov (United States)

    Denschlag, Dominik; Bettendorf, Herta; Watermann, Dirk; Keck, Christoph; Tempfer, Clemens; Pietrowski, Detlef

    2005-07-01

    To evaluate the association between the presence of uterine leiomyoma and two single nuclear polymorphisms of the p53 tumor suppressor and the angiopoietin-2 (ANGPT2) genes. Prospective case control study. Academic research institution. One hundred thirty-two women with clinically and surgically diagnosed uterine leiomyomas and 280 controls. Peripheral venous puncture. Genotyping was performed by polymerase chain reaction-based amplification of the Arg and Pro variants at codon 72 of the p53 gene and by restriction fragment length polymorphism analysis of the G/G and G/A alleles in exon 4 of the ANGPT2 gene. Comparing women with uterine leiomyomas and controls, no statistically significant difference with respect to allele frequency and genotype distribution were ascertained for the ANGPT2 polymorphism (P=.2 and P=.5, respectively). However, for the p53 tumor suppressor gene polymorphism, statistically significant differences in terms of a higher Pro allele frequency and a higher prevalence of the Pro/Pro genotype among women with uterine leiomyoma (32.0% vs. 16.0%, respectively, and 21.3% vs. 4.7%, respectively) were ascertained (P=.001, OR 1.74; 95% CI 1.24-2.45, P=.001; OR 3.84, 95% CI 1.81-8.14; respectively). Carriage of the p53 polymorphism at codon 72 predicts the susceptibility to leiomyoma in a Caucasian population and may contribute to the pathogenesis of uterine leiomyoma.

  6. [Application of TB type thermal balloon endometrial ablation for the treatment of abnormal uterine bleeding].

    Science.gov (United States)

    Wang, W; Zhai, Y; Zhang, Z H; Li, Y; Zhang, Z Y

    2016-11-08

    Objective: To investigate the clinical efficacy, safety and promotion value of TB type thermal balloon endometrial ablation in the treatment of abnormal uterine bleeding. Methods: Fourty three patients who had received TB type endometrial ablation system for treatment of abnormal uterine bleeding from January, 2015 to January, 2016 in theDepartment of gynecology, Beijing Chaoyang Hospital were enrolled in this study. The intra-operative and post-operative complications and improvement of abnormal uterine bleeding and dysmenorrhea were observed. Results: There were nointra-operative complication occurred, such as uterine perforation, massive hemorrhage or surrounding organ damage. At 6 months after operation, 32 patients developed amenorrhea, 6 developed menstrual spotting, 3 developed menstruation with a small volume and 1 had a normal menstruation. No menstruation with an increased volume occurred. The occurrence of amenorrhea was 76.19% and the response rate was 97.62%.At 6 months after operation, 1 case had no response, 2 cases had partial response and 11 cases had complete response among the 14 cases of pre-operative dysmenorrhea; only 3 cases still had anemia among the 23 cases of pre-operative anemia. Compared with before treatment, patients with dysmenorrhea and anemia both significantly reduced with a statistically significant difference( P abnormal uterine bleeding, which could have clinical promotion practice.

  7. Recurrent venous thromboembolism and abnormal uterine bleeding with anticoagulant and hormone therapy use.

    Science.gov (United States)

    Martinelli, Ida; Lensing, Anthonie W A; Middeldorp, Saskia; Levi, Marcel; Beyer-Westendorf, Jan; van Bellen, Bonno; Bounameaux, Henri; Brighton, Timothy A; Cohen, Alexander T; Trajanovic, Mila; Gebel, Martin; Lam, Phuong; Wells, Philip S; Prins, Martin H

    2016-03-17

    Women receiving vitamin K antagonists (VKAs) require adequate contraception because of the potential for fetal complications. It is unknown whether the use of hormonal therapy, especially those containing estrogens, is associated with recurrent venous thromboembolism (VTE) during anticoagulation. Despite the absence of data, World Health Organization guidelines state that use of estrogen-containing contraceptives confers an "unacceptable health risk" during established anticoagulation for VTE. We compared the incidences of recurrent VTE and abnormal uterine bleeding with and without concomitant hormonal therapy in women aged abnormal uterine bleeding. In total, 1888 women were included. VTE incidence densities on and off hormonal therapy were 3.7%/year and 4.7%/year (adjusted HR, 0.56; 95% confidence interval [CI], 0.23-1.39), respectively, and were 3.7%/year and 3.8%/year, respectively, for estrogen-containing and progestin-only therapy. The adjusted HR for all abnormal uterine bleeding (on vs off hormonal therapy) was 1.02 (95% CI, 0.66-1.57). Abnormal uterine bleeding occurred more frequently with rivaroxaban than with enoxaparin/VKA (HR, 2.13; 95% CI, 1.57-2.89). Hormonal therapy was not associated with an increased risk of recurrent VTE in women receiving therapeutic anticoagulation. The observed increased risk of abnormal uterine bleeding with rivaroxaban needs further exploration. © 2016 by The American Society of Hematology.

  8. Clinical characteristic and intraoperative findings of uterine perforation patients in using of intrauterine devices (IUDs).

    Science.gov (United States)

    Sun, Xin; Xue, Min; Deng, Xinliang; Lin, Yun; Tan, Ying; Wei, Xueli

    2018-01-01

    Intrauterine devices (IUDs) are the most popular form of contraception used worldwide; however, IUD is not risk-free. IUD migrations, especially uterine perforations, were frequently occurred in patients. The aim of this study was to investigate the clinical characteristics and intraoperative findings in patients with migrated IUDs. 29 cases of uterine perforation associated with migrated IUDs and 69 control patients were followed between January 2008 to March 2015. Patients who used IUDs within first 6 months from the last delivery experienced a characteristically high rate of the perforation of the uterine wall. A significantly larger number of IUD insertion associated with uterine perforation were performed in rural hospitals or operated at a lower level health care system. There was no clear difference in the age and presented symptoms in patients between two groups. Majority of contraceptive intrauterine devices was the copper-releasing IUDs. Furthermore, patients who used V-shaped IUD showed significantly higher incidence of pelvic adhesions when compared with the users of O-shaped IUDs. Unique clinical characteristics of IUD migration were identified in patients with uterine perforation. Hysteroscopy and/or laparoscopy were the effective approaches to remove the migrated IUDs. Improving operating skills is required at the lower level of health care system.

  9. Surgical findings at laparatomy for uterine fibroid in University of ...

    African Journals Online (AJOL)

    A three year review of the surgical findings at Laparotomy for uterine fibroids at the ... that uterine fibroid plays a role in the process of spontaneous conception. ... Other factors found to be associated with uterine fibroid are the numbers, size, ...

  10. Uterine rupture after previous low segment transverse cesarean is rarely catastrophic.

    Science.gov (United States)

    Soltsman, Sofia; Perlitz, Yuri; Ben Ami, Moshe; Ben Shlomo, Izhar

    2018-03-01

    The cornerstone of concerns over trial of labor after cesarean (TOLAC) is the risk of uterine rupture. The purpose of this study was to document the rate of uterine rupture during TOLAC and to delineate its severity and consequences. We retrospectively collected the data on vaginal and cesarean deliveries after a previous cesarean section with specific emphasis on uterine rupture and dehiscence in our center from 2006 through 2013. 22,670 deliveries were registered, with 18.2% rate of cesarean section. 2890 women had a single cesarean scar; of them 1206 delivered vaginally and 194 were re-operated during unsuccessful TOLAC. Seven cases of uterine rupture and 16 cases of dehiscence were recorded. There were no maternal, intrapartum or neonatal deaths, and no cesarean hysterectomy. There was one re-laparotomy, one ICU admission, and one blood transfusion; one neonate was admitted to NICU. TOLAC was successful in 86.1% of cases. Cautious selection and close monitoring of candidates are the cornerstones of successful management of TOLAC. Readily available facilities for emergency cesarean delivery and concerted obstetrical team can save the mother and child from catastrophic complications.

  11. Fertility after uterine artery embolization of fibroids

    DEFF Research Database (Denmark)

    Karlsen, K; Hrobjartsson, A; Korsholm, M

    2018-01-01

    PURPOSE: The impact of uterine artery embolization (UAE) for the purpose of diminishing the effect of uterine fibroids on fertility is unclear. We have investigated the reported rates of pregnancy and miscarriage after treatment of uterine fibroids with UAE. MATERIALS AND METHODS: We searched...... intervention was included. The PRISMA guideline was used to do a systematic review using the main outcomes pregnancy rate and miscarriage rate. Risk of bias was assessed by the Cochrane risk of bias tool or by ROBINS-I. The quality of evidence was assessed by the GRADE approach. RESULTS: We included 17 studies...... (989 patients): 1 RCT, 2 cohort studies, and 14 case series. Pregnancy rates after UAE were 50% in the RCT and 51 and 69% in the cohort studies. Among the case series median pregnancy rate was 29%. Miscarriage rates were 64% in the RCT. Miscarriage rates at 56 and 34% were found in the cohort studies...

  12. HMB-45 reactivity in conventional uterine leiomyosarcomas.

    Science.gov (United States)

    Simpson, Karen W; Albores-Saavedra, Jorge

    2007-01-01

    We studied the human melanoma black-45 (HMB-45) reactivity in 25 uterine leiomyosarcomas including 23 conventional and 2 myxoid variants. Eleven tumors were poorly differentiated, and 14 were well to moderately differentiated. Nine uterine leiomyosarcomas labeled with HMB-45 in 10% or less of the tumor cells. Six were poorly differentiated and 3 were well differentiated. Our study indicates that 36% of conventional leiomyosarcomas focally express HMB-45. HMB-45 reactivity was more common in the poorly differentiated than in the well-differentiated group of leiomyosarcomas. In light of our findings and of those recently reported in the literature, we believe that the term PEComa should not be used for uterine leiomyosarcomas with clear cells or for conventional leiomyosarcomas that stain positively with HMB-45.

  13. Imaging before and after uterine artery embolization

    International Nuclear Information System (INIS)

    Kroencke, T.J.

    2008-01-01

    Percutaneous catheter-based embolization treatment of symptomatic uterine fibroids has evolved into the most widely used alternative therapeutic approach to surgical treatment worldwide. Uterine artery embolization (UAE) induces infarction of leiomyomas, resulting in ischemic necrosis, hyaline degeneration, and size reduction with resolution of associated symptoms. Published experience suggests that UAE is an effective and reliable option for treating uterine fibroids with high patient satisfaction. Magnetic resonance imaging (MRI) is superior to ultrasonography for determining the site, size and number of fibroids, which is important for establishing the indication for UAE. Other potential advantages of MRI include the option of performing MR angiography (MRA) and obtaining contrast-enhanced images for monitoring the outcome of UAE and assessing possible complications after UAE. (orig.) [de

  14. The effects of honey compared to silver sulfadiazine for the treatment of burns: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Aziz, Zoriah; Abdul Rasool Hassan, Bassam

    2017-02-01

    Evidence from animal studies and trials suggests that honey may accelerate wound healing. The objective of this review was to assess the effects of honey compared with silver dressings on the healing of burn wounds. Relevant databases for randomized controlled trials (RCTs) of honey compared with silver sulfadiazine (SSD) were searched. The quality of the selected trials was assessed using the Cochrane Risk of Bias Assessment Tool. The primary endpoints considered were wound healing time and the number of infected wounds rendered sterile. Nine RCTs met the inclusion criteria. Based on moderate quality evidence there was a statistically significant difference between the two groups, favoring honey in healing time (MD -5.76days, 95% CI -8.14 to -3.39) and the proportions of infected wounds rendered sterile (RR 2.59; 95% CI 1.58-2.88). The available evidence suggests that honey dressings promote better wound healing than silver sulfadiazine for burns. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  15. Adaptation and dissemination of an evidence-based obesity prevention intervention: design of a comparative effectiveness trial.

    Science.gov (United States)

    Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L

    2014-07-01

    Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. Effectiveness of intra-arterial anesthesia for uterine fibroid embolization using dilute lidocaine

    International Nuclear Information System (INIS)

    Zhan, Songhua; Li, Yi; Wang, Guoliang; Han, Hongjie; Yang, Zhenyan

    2005-01-01

    A modified protocol of uterine fibroid embolization (UFE) is proposed for alleviating the postinterventional pain. This randomized and double-blinded clinical trial is to evaluate the effectiveness of intra-arterial infusion of dilute lidocaine for postinterventional pain relief in UFE. Forty-six patients who underwent UFE were randomly grouped equally. In the test group, after the poly(vinyl alcohol) embolization was complete, a dilute lidocaine solution with 40 mg in 6.0 ml, 3.0 ml for each side or 4.0 and 2.0 ml for two sides, was given through the catheter. In the control group, the patients received 6.0 ml of saline solution as a placebo. A simple pain degree classification method for patient self-evaluation was developed. A questionnaire was completed by each patient to record the degree of pain during five periods; these were during the procedure, the first 12 h, the second 12 h, between 24 and 48 h, and between 48 and 72 h. The numbers of patients with the same degree of pain in the five time segments from the two groups were statistically compared. Compared with the control group, the patients in the test group experienced less pain within 48 h after the procedure (p<0.01). The results suggest that this improved UFE protocol is a simple approach to prevent the acute postinterventional pain of UFE. (orig.)

  17. Effectiveness of intra-arterial anesthesia for uterine fibroid embolization using dilute lidocaine

    Energy Technology Data Exchange (ETDEWEB)

    Zhan, Songhua; Li, Yi; Wang, Guoliang; Han, Hongjie; Yang, Zhenyan [Tongji Hospital of Tongji University, Department of Radiology, Shanghai (China)

    2005-08-01

    A modified protocol of uterine fibroid embolization (UFE) is proposed for alleviating the postinterventional pain. This randomized and double-blinded clinical trial is to evaluate the effectiveness of intra-arterial infusion of dilute lidocaine for postinterventional pain relief in UFE. Forty-six patients who underwent UFE were randomly grouped equally. In the test group, after the poly(vinyl alcohol) embolization was complete, a dilute lidocaine solution with 40 mg in 6.0 ml, 3.0 ml for each side or 4.0 and 2.0 ml for two sides, was given through the catheter. In the control group, the patients received 6.0 ml of saline solution as a placebo. A simple pain degree classification method for patient self-evaluation was developed. A questionnaire was completed by each patient to record the degree of pain during five periods; these were during the procedure, the first 12 h, the second 12 h, between 24 and 48 h, and between 48 and 72 h. The numbers of patients with the same degree of pain in the five time segments from the two groups were statistically compared. Compared with the control group, the patients in the test group experienced less pain within 48 h after the procedure (p<0.01). The results suggest that this improved UFE protocol is a simple approach to prevent the acute postinterventional pain of UFE. (orig.)

  18. A comparative trial of psychotherapy and pharmacotherapy for "pure" dysthymic patients.

    Science.gov (United States)

    Markowitz, John C; Kocsis, James H; Bleiberg, Kathryn L; Christos, Paul J; Sacks, Michael

    2005-12-01

    Psychotherapy of "pure" dysthymic disorder remains understudied. This article reports outcomes of an acute randomized trial of 94 subjects treated for 16 weeks with either interpersonal psychotherapy (IPT), brief supportive psychotherapy (BSP), sertraline, or sertraline plus IPT. Recruited by clinical referral and advertising, subjects met DSM-IV criteria for early onset dysthymic disorder, with no episode of major depression in the prior six months. They were randomly assigned to one of four 16-week treatments, with options for crossover or continuation treatment. Results were analyzed from the intention-to-treat sample by ANCOVA, controlling for baseline depressive severity. Subjects improved in all conditions over time, with the cells including sertraline pharmacotherapy showing superiority over psychotherapy alone for response and remission. Response rates were 58% for sertraline alone, 57% for combined treatment, 35% for IPT, and 31% for BSP. The study was underpowered and may have employed too "active" a control condition. Follow-up data were unobtainable. In this acute trial for "pure" dysthymic disorder, sertraline with or without IPT showed advantages relative to IPT and BSP. Methodological difficulties may have limited differential outcome findings. This study bolsters a small but growing literature on the treatment of dysthymic disorder, suggesting that pharmacotherapy may acutely benefit patients more than psychotherapy.

  19. A 5-year randomized trial to compare 1 or 2 implants for implant overdentures.

    Science.gov (United States)

    Bryant, S R; Walton, J N; MacEntee, M I

    2015-01-01

    The hypothesis of this 5-y randomized clinical trial was that there would be no significant difference in the satisfaction of edentulous participants with removable complete overdentures attached to 1 or 2 mandibular implants. Secondary aims were to test changes in satisfaction between and within the groups from baseline to 5 y and differences between the groups in implant survival and prosthodontic maintenance over 5 y. Each of the 86 participants (mean age, 67 y) was randomly allocated to receive either 1 implant in the midline (group 1) or 2 implants in the canine areas (group 2) attached to a mandibular overdenture opposing a maxillary complete denture. Satisfaction was self-assessed by participants on a visual analog scale at baseline prior to implants, as well as at 2 mo and 1, 3, and 5 y with implant overdentures, whereas implant survival and prosthodontic maintenance were assessed by clinical examination. After 5 y, 29 participants in group 1 and 33 in group 2 were available, with most dropouts due to death. Satisfaction with the implant denture after 5 y was significantly (P overdentures retained by 1 implant or 2 implants. Additional research is required to confirm long-term treatment effectiveness of single-implant dentures and the implications of prosthetic maintenance with implant overdentures (ClinicalTrials.gov: NCT02117856). © International & American Associations for Dental Research 2014.

  20. The INeS study: prevention of multiple pregnancies: a randomised controlled trial comparing IUI COH versus IVF e SET versus MNC IVF in couples with unexplained or mild male subfertility

    Directory of Open Access Journals (Sweden)

    Beckers Nicole

    2009-12-01

    Full Text Available Abstract Background Multiple pregnancies are high risk pregnancies with higher chances of maternal and neonatal mortality and morbidity. In the past decades the number of multiple pregnancies has increased. This trend is partly due to the fact that women start family planning at an increased age, but also due to the increased use of ART. Couples with unexplained or mild male subfertility generally receive intrauterine insemination IUI with controlled hormonal stimulation (IUI COH. The cumulative pregnancy rate is 40%, with a 10% multiple pregnancy rate. This study aims to reveal whether alternative treatments such as IVF elective Single Embryo Transfer (IVF e SET or Modified Natural Cycle IVF (MNC IVF can reduce the number of multiple pregnancy rates, but uphold similar pregnancy rates as IUI COH in couples with mild male or unexplained subfertility. Secondly, the aim is to perform a cost effective analyses and assess treatment preference of these couples. Methods/Design We plan a multicentre randomised controlled clinical trial in the Netherlands comparing six cycles of intra-uterine insemination with controlled ovarian hyperstimulation or six cycles of Modified Natural Cycle (MNC IVF or three cycles with IVF-elective Single Embryo Transfer (eSET plus cryo-cycles within a time frame of 12 months. Couples with unexplained subfertility or mild male subfertility and a poor prognosis for treatment independent pregnancy will be included. Women with anovulatory cycles, severe endometriosis, double sided tubal pathology or serious endocrine illness will be excluded. Our primary outcome is the birth of a healthy singleton. Secondary outcomes are multiple pregnancy, treatment costs, and patient experiences in each treatment arm. The analysis will be performed according tot the intention to treat principle. We will test for non-inferiority of the three arms with respect to live birth. As we accept a 12.5% loss in pregnancy rate in one of the two IVF arms

  1. Letrozole compared with tamoxifen for elderly patients with endocrine-responsive early breast cancer: the BIG 1-98 trial

    DEFF Research Database (Denmark)

    Crivellari, D.; Sun, Z.; Coates, A.S.

    2008-01-01

    PURPOSE: To explore potential differences in efficacy, treatment completion, and adverse events (AEs) in elderly women receiving adjuvant tamoxifen or letrozole for five years in the Breast International Group (BIG) 1-98 trial. METHODS: This report includes the 4,922 patients allocated to 5 years...... of letrozole or tamoxifen in the BIG 1-98 trial. The median follow-up was 40.4 months. Subpopulation Treatment Effect Pattern Plot (STEPP) analysis was used to examine the patterns of differences in disease-free survival and incidences of AEs according to age. In addition, three categoric age groups were...... had superior efficacy (DFS) compared with tamoxifen in all age groups. On the basis of a small number of patients older than 75 years (6%), age per se should not unduly affect the choice of adjuvant endocrine therapy Udgivelsesdato: 2008/4/20...

  2. The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only.

    Science.gov (United States)

    Garner, Alan A; Mann, Kristy P; Fearnside, Michael; Poynter, Elwyn; Gebski, Val

    2015-11-01

    Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care. Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score definition), or GCSdefinition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned. 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), pdefinition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different. This trial suggests a potential mortality reduction in patients with blunt trauma with GCSdefinition only). Confirmatory studies which also address non-compliance issues are needed. NCT00112398. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  3. Radiological appearances of degenerative uterine leiomyomas

    International Nuclear Information System (INIS)

    Tzvetankov, K.; Hadjidekov, G.; Plachkov, I.; Yankova, M.

    2013-01-01

    Uterine fibroids, also known as leiomyomas, are the most common uterine neoplasms. Although benign, they can be associated with significant morbidity and are the commonest indication for hysterectomy. They are often discovered incidentally when performing imaging for other reasons. Usually first identified with US, they can be further characterized with MRI. They are usually easily recognizable, but degenerate fibroids can have unusual appearances. Knowledge of the different appearances of fibroids on imaging is important as it enables prompt diagnosis and thereby guides treatment. (authors)

  4. Uterine prolapse prevention in Eastern Nepal

    DEFF Research Database (Denmark)

    Radl, Christina Mathilde; Rajwar, Ranjita; Aro, Arja R.

    2012-01-01

    are working well or the attitudes toward them. This paper presents the findings of a qualitative study on primary and secondary prevention of uterine prolapse in Eastern Nepal. Method: The study involved eight focus group discussions with 71 women in six villages of the eastern districts of Siraha and Saptari......: It was found that patriarchy, gender discrimination, and cultural traditions such as early marriage and pregnancy make it difficult for people to discontinue uterine prolapse risk behaviors. Women are aware of risk factors, prevention, and treatment, but are powerless to change their situations. Health...

  5. Dropout Rates in Randomized Clinical Trials of Antipsychotics: A Meta-analysis Comparing First- and Second-Generation Drugs and an Examination of the Role of Trial Design Features

    OpenAIRE

    Rabinowitz, Jonathan; Levine, Stephen Z.; Barkai, Orna; Davidov, Ori

    2008-01-01

    Dropout is often used as an outcome measure in clinical trials of antipsychotic medication. Previous research is inconclusive regarding (a) differences in dropout rates between first- and second-generation antipsychotic medications and (b) how trial design features reduce dropout. Meta-analysis of randomized controlled trials (RCTs) of antipsychotic medication was conducted to compare dropout rates for first- and second-generation antipsychotic drugs and to examine how a broad range of design...

  6. The clinical value of the special functions of DSA in interventional embolization for uterine fibroids

    International Nuclear Information System (INIS)

    He Yushen; Lu Dong; Lv Weifu; Zhang Jingsong

    2009-01-01

    Objective: To evaluate the special functions of DSA in interventional embolization therapy for uterine fibroids. Methods: The special functions of DSA, including 3D-DSA, the optimal working position and road-mapping technique, were utilized in performing interventional embolization therapy for uterine fibroids in twenty-six cases (experimental group). Routine DSA angiography was employed in twenty cases(control group). The volume of contrast media used, the time of completing the interventional procedure and the total fluoroscopic time in two groups were compared and the results were analyzed. Results: The difference in the volume of contrast agent used and in the total fluoroscopic time between two groups was statistically significant (P 0.05). Conclusion: In treating uterine fibroids with interventional embolization, the use of the special functions of DSA can reduce the manipulation time and lower the operation risk. Moreover, the technique of visible 3D reconstruction image is of great significance in guiding the procedure. (authors)

  7. Rationale for a randomized controlled trial comparing two prophylaxis regimens in adults with severe hemophilia A: the Hemophilia Adult Prophylaxis Trial

    Science.gov (United States)

    Ragni, Margaret V

    2011-01-01

    A major goal of comprehensive hemophilia care is to prevent occurrence of bleeds by prophylaxis or regular preventive factor, one or more times weekly. Although prophylaxis is effective in reducing bleeding and joint damage in children, whether it is necessary to continue into adulthood is not known. The purpose of this article is to describe a Phase III randomized controlled trial to evaluate prophylaxis comparing two dose regimens in adults with severe hemophilia A. I hypothesize that adults with mature cartilage and joints are less susceptible to joint bleeds and joint damage, and that once-weekly recombinant factor VIII prophylaxis, with up to two rescue doses per week, is as effective as thrice-weekly prophylaxis in reducing bleeding frequency, but less costly and more acceptable, with higher quality of life. The ultimate goal of this project is to determine whether once-weekly prophylaxis is any worse than thrice-weekly prophylaxis in reducing joint bleeding frequency, while potentially utilizing less factor, at lower cost, leading to a better quality of life. This is an innovative concept, as it challenges the current paradigm of thrice-weekly prophylaxis in adults, which is based on dosing in children. Furthermore, this trial will assess interdose thrombin generation, a novel tissue factor-based assay of hemostasis, to determine if individualized thrombin generation can predict more individualized prophylaxis dosing, which would be practice changing. PMID:21939418

  8. Randomized clinical trial comparing an oral carbohydrate beverage with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, T; Kristiansen, V B; Hjortsø, N C

    2004-01-01

    BACKGROUND: Preoperative oral carbohydrate can attenuate postoperative insulin resistance and catabolism, and may have the potential to improve postoperative recovery. There are no data from randomized studies on postoperative clinical outcome after specific surgical procedures. This study...... evaluated the clinical effects of a preoperative carbohydrate beverage in patients undergoing laparoscopic cholecystectomy. METHODS: Ninety-four patients undergoing laparoscopic cholecystectomy were included in a randomized clinical trial. Patients were randomized to receive 800 ml of an iso-osmolar 12.......5 per cent carbohydrate-rich beverage the evening before operation (100 g carbohydrate) and another 400 ml (50 g carbohydrate) 2 h before initiation of anaesthesia, or the same volume of a placebo beverage. The primary endpoint was general well-being the day after operation. Patients were evaluated from...

  9. Measurement of uterine natural killer cell percentage in the periimplantation endometrium from fertile women and women with recurrent reproductive failure: establishment of a reference range.

    Science.gov (United States)

    Chen, Xiaoyan; Mariee, Najat; Jiang, Lingming; Liu, Yingyu; Wang, Chi Chiu; Li, Tin Chiu; Laird, Susan

    2017-12-01

    Uterine natural killer cells are the major leukocytes present in the periimplantation endometrium. Previous studies have found controversial differences in uterine natural killer cell percentage in women with recurrent reproductive failure compared with fertile controls. We sought to compare the uterine natural killer cell percentage in women with recurrent reproductive failure and fertile controls. This was a retrospective study carried out in university hospitals. A total of 215 women from 3 university centers participated in the study, including 97 women with recurrent miscarriage, 34 women with recurrent implantation failure, and 84 fertile controls. Endometrial biopsy samples were obtained precisely 7 days after luteinization hormone surge in a natural cycle. Endometrial sections were immunostained for CD56 and cell counting was performed by a standardized protocol. Results were expressed as percentage of positive uterine natural killer cell/total stromal cells. The median uterine natural killer cell percentage in Chinese ovulatory fertile controls in natural cycles was 2.5% (range 0.9-5.3%). Using 5th and 95th percentile to define the lower and upper limits of uterine natural killer cell percentage, the reference range was 1.2-4.5%. Overall, the groups with recurrent reproductive failure had significantly higher uterine natural killer cell percentage than the controls (recurrent miscarriage: median 3.2%, range 0.6-8.8%; recurrent implantation failure: median 3.1%, range 0.8-8.3%). However, there was a subset of both groups (recurrent miscarriage: 16/97; recurrent implantation failure: 6/34) that had lower uterine natural killer cell percentage compared to fertile controls. A reference range for uterine natural killer cell percentage in fertile women was established. Women with recurrent reproductive failure had uterine natural killer cell percentages both above and below the reference range. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Comparison of MR imaging and CT in the evaluation of uterine tumors

    International Nuclear Information System (INIS)

    Janus, C.L.; Dottino, P.; Brodman, M.; Goodman, H.; Gendal, E.S.; Rabinowitz, J.G.

    1987-01-01

    The authors compared the usefulness of MR imaging and CT in staging uterine tumors. Forty women with known cervical carcinoma, endometrial cancer, or leiomyosarcoma underwent CT and MR imaging within 1 week prior to surgery. MR imaging was better than CT for localizing tumors to the endometrium of myometrium and in the evaluation of lymph node involvement and extension to the cervix and parametria. MR imaging, with its superior ability to demonstrate pelvic anatomy and its lack of ionizing radiation and risk from iodinated contrast media, has an important place in the staging of uterine tumors

  11. Surgical site infection: an observer-blind, randomized trial comparing electrocautery and conventional scalpel.

    Science.gov (United States)

    Rongetti, Regiane Ladislau; Oliveira e Castro, Paulo de Tarso; Vieira, Renê Aloisio da Costa; Serrano, Sérgio Vicente; Mengatto, Mariana Fabro; Fregnani, José Humberto Tavares Guerreiro

    2014-01-01

    To evaluate the incidence of surgical site infection (SSI) based on the type of scalpel used for incisions in the skin and in subcutaneous tissues. Observer-blind, randomized equivalence clinical trial with two arms (electrocautery versus conventional scalpel) which evaluated 133 women undergoing elective abdominal gynecologic oncology surgery. A simple randomization stratified by body mass index (BMI: 30 kg/m(2)) was carried out. Women were evaluated at 14 and 30 days following the operation. A multivariate analysis was performed in order to check whether the type of scalpel would be a risk factor for SSI. Group arms were balanced for all variables, excepted for surgical time, which was significantly higher in the electrocautery group (mean: 161.1 versus 203.5 min, P = 0.029). The rates of SSI were 7.4% and 9.7%, respectively, for the conventional scalpel and electrocautery groups (P = 0.756). The exploratory multivariate model identified body mass index ≥30 kg/m(2) (OR = 24.2, 95% CI: 2.8-212.1) and transverse surgical incision (OR = 8.1, 95% CI: 1.5-42.6) as independent risk factors for SSI. The type of scalpel used in surgery, when adjusted for these variables and the surgery time, was not a risk factor for SSI. This study showed that the SSI rates for conventional scalpel and electrocautery were not significantly different. These results were consistent with others reported in the literature and would not allow a surgeon to justify scalpel choice based on SSI. NCT01410175 (Clinical Trials - NIH). Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  12. The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only

    Science.gov (United States)

    Garner, Alan A; Mann, Kristy P; Fearnside, Michael; Poynter, Elwyn; Gebski, Val

    2015-01-01

    Background Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care. Methods Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score <9 (original definition), or GCS<13 and an Abbreviated Injury Scale score for the head region ≥3 (modified definition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned. Results 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), p<0.01, Number needed to treat =6. 338 patients met the modified definition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different. Conclusions This trial suggests a potential mortality reduction in patients with blunt trauma with GCS<9 receiving additional physician care (original definition only). Confirmatory studies which also address non-compliance issues are needed. Trial registration number NCT00112398. PMID:25795741

  13. Vaginal and Uterine Bacterial Communities in Postpartum Lactating Cows

    Directory of Open Access Journals (Sweden)

    Brooke A. Clemmons

    2017-06-01

    Full Text Available Reproductive inefficiency in cattle has major impacts on overall productivity of cattle operations, increasing cost of production, and impacting the sustainability of the cattle enterprise. Decreased reproductive success and associated disease states have been correlated with the presence of specific microbes and microbial community profiles, yet details of the relationship between microbial communities and host physiology are not well known. The present study profiles and compares the microbial communities in the bovine uterus and vagina using 16S rRNA sequencing of the V1–V3 hypervariable region at the time of artificial insemination. Significant differences (p < 0.05 between the vaginal and uterine communities were observed at the level of α-diversity metrics, including Chao1, Shannon’s Diversity Index, and observed OTU. Greater clustering of vaginal OTU was apparent in principal coordinate analysis compared to uterine OTU, despite greater diversity in the vaginal community in both weighted and unweighted UniFrac distance matrices (p < 0.05. There was a significantly greater relative abundance of unassigned taxa in the uterus (p = 0.008, otherwise there were few differences between the overall community profiles. Both vaginal and uterine communities were dominated by Firmicutes, although the relative abundance of rRNA sequences corresponding to species in this phylum was significantly (p = 0.007 lower in the uterine community. Additional differences were observed at the genus level, specifically in abundances within Clostridium (p = 0.009, Anaerofustis (p = 0.018, Atopobium (p = 0.035, Oscillospira (p = 0.035, 5-7N15 (p = 0.035, Mycoplasma (p = 0.035, Odoribacter (p = 0.042, and within the families Clostridiaceae (p = 0.006, Alcaligenaceae (p = 0.021, and Ruminococcaceae (p = 0.021. Overall, the comparison revealed differences and commonalities among bovine reproductive organs, which may be influenced by host physiology. The increased

  14. Effect of magnetic resonance imaging characteristics on uterine fibroid treatment

    Directory of Open Access Journals (Sweden)

    Duc NM

    2018-04-01

    Full Text Available Nguyen Minh Duc, Huynh Quang HuyDepartment of Radiology, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, VietnamAbstract: Uterine fibroids are the most common gynecological benign tumors adversely affecting the quality of life of women of a reproductive age. Magnetic resonance imaging (MRI is efficient at localizing the site of lesions and characterizing uterine fibroids before treatment. Understanding the different characteristics of uterine fibroids on MRI is essential, because it not only enables prompt diagnosis, but also guides the development of suitable therapeutic methods. This pictorial review demonstrates the effect of MRI features on uterine fibroid treatment. Keywords: uterine fibroids, characteristics, magnetic resonance imaging, treatments

  15. A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856.

    Science.gov (United States)

    Shubert, Christopher R; Ferrone, Christina R; Fernandez-Del Castillo, Carlos; Kendrick, Michael L; Farnell, Michael B; Smoot, Rory L; Truty, Mark J; Que, Florencia G

    2016-11-01

    Pancreatic leak is common after distal pancreatectomy. This trial sought to compare TissueLink closure of the pancreatic stump to that of SEAMGUARD. A multicenter, prospective, trial of patients undergoing distal pancreatectomy randomized to either TissueLink or SEAMGUARD. Enrollment was closed early due to poor accrual. Overall, 67 patients were enrolled, 35 TissueLink and 32 SEAMGUARD. The two groups differed in American Society of Anesthesiologist class and diagnosis at baseline and were relatively balanced otherwise. Overall, 37 of 67 patients (55%) experienced a leak of any grade, 15 (46.9%) in the SEAMGUARD arm and 22 (62.9%) in the TissueLink arm (P = 0.19). The clinically significant leak rate was 17.9%; 22.9% for TissueLink and 12.5% for SEAMGUARD (P = 0.35). There were no statistically significant differences in major or any pancreatic fistula-related morbidity between the two groups. This is the first multicentered randomized trial evaluating leak rate after distal pancreatectomy between two common transection methods. Although a difference in leak rates was observed, it was not statistically significant and therefore does not provide evidence of the superiority of one technique over the other. Choice should remain based on surgeon comfort, experience, and pancreas characteristics. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial.

    Science.gov (United States)

    Zeng, Yuxiao; Zhang, Xuecheng; Zhou, Jing; Wang, Xinwei; Jiao, Ruimin; Liu, Zhishun

    2018-05-01

    To treat functional constipation, both electroacupuncture (EA) therapy and transcutaneous electric nerve stimulation (TENS) are safe and effective. However, no head-to-head comparison trial has been conducted. This trial compares the efficacy of electroacupuncture relative to transcutaneous electric nerve stimulation for functional constipation. Individuals with functional constipation will be randomly allocated to receive either EA or TENS (n = 51, each), 3 times per week for 8 weeks. The primary outcome is the percentage of participants with an average increase from baseline of 1 or more complete spontaneous bowel movements at week 8. The secondary outcome measures are the following: at the time of visits, changes in the number of complete spontaneous bowel movements, number of spontaneous bowel movements, stool character, difficulty in defecation, patients' assessment of quality of life regarding constipation (self-report questionnaire), and use of auxiliary defecation methods. The results of this trial should verify whether EA is more efficacious than TENS for relieving symptoms of functional constipation. The major limitation of the study is the lack of blinding of the participants and acupuncturist.

  17. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  18. Comparison of bloody pap smear fixation by Carnoy’s and fixator spray in samples from women with abnormal uterine bleeding

    Directory of Open Access Journals (Sweden)

    Keshavarz Najmeh

    2016-05-01

    Full Text Available Abnormal uterine bleeding is a serious problem among women of late reproductive age. Cervical cancer is one of the reasons of AUB and Pap smear is the best way to diagnose it. Blood has negative effects on Pap smear especially in AUB with great blood. One of the effective solutions for lysing RBC is Carnoy’s. This study aims to compare two methods of fixation in bloody Pap smear by Carnoy’s and normal spray in samples from women with AUB. This study was done on 204 bloody Pap smear from 102 women with AUB that referred to Zeinabieh and Faghihi hospitals of Shiraz University of Medical Sciences from2012-2013. After observing uterine bleeding in each subject, two samples were provided using usual Pap smear method; one of the slides was fixed by normal spray and the other slide fixed by Carnoy’s solution for20 minutes. After staining (Papanicolaou method, two pathologists performed a double-blind trial to analyze them. Data analysis was done using SPSS. 82 samples did not have cell adequacy. Squamous cells in Carnoy’s-fixed slides were more than spray-fixed ones (p=0.024. The decrease in the number of RBC on slides and the increase in the clarity of slides in Carnoy’s-fixed samples were more than sprayfixed slides (p=0.001, while identifying inflammatory cells(p=0.832 and microbial factors (p=1 in both methods showed no significant difference. Carnoy’s solution can be used as an effective fixative in bloody Pap smear from women with abnormal uterine bleeding.

  19. MRI Assessment of Uterine Artery Patency and Fibroid Infarction Rates 6 Months after Uterine Artery Embolization with Nonspherical Polyvinyl Alcohol

    International Nuclear Information System (INIS)

    Das, Raj; Gonsalves, Michael; Vlahos, Ioannis; Manyonda, Issac; Belli, Anna-Maria

    2013-01-01

    Purpose: We have observed significant rates of uterine artery patency after uterine artery embolization (UAE) with nonspherical polyvinyl alcohol (nsPVA) on 6 month follow-up MR scanning. The study aim was to quantitatively assess uterine artery patency after UAE with nsPVA and to assess the effect of continued uterine artery patency on outcomes. Methods: A single centre, retrospective study of 50 patients undergoing bilateral UAE for uterine leiomyomata was undertaken. Pelvic MRI was performed before and 6 months after UAE. All embolizations were performed with nsPVA. Outcome measures included uterine artery patency, uterine and dominant fibroid volume, dominant fibroid percentage infarction, presence of ovarian arterial collaterals, and symptom scores assessed by the Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL). Results: Magnetic resonance angiographic evidence of uterine artery recanalization was demonstrated in 90 % of the patients (64 % bilateral, 26 % unilateral) at 6 months. Eighty percent of all dominant fibroids demonstrated >90 % infarction. The mean percentage reduction in dominant fibroid volume was 35 %. No significant difference was identified between nonpatent, unilateral, and bilateral recanalization of the uterine arteries with regard to percentage dominant fibroid infarction or dominant fibroid volume reduction. The presence of bilaterally or unilaterally patent uterine arteries was not associated with inferior clinical outcomes (symptom score or UFS-QOL scores) at 6 months. Conclusion: The high rates of uterine artery patency challenge the current paradigm that nsPVA is a permanent embolic agent and that permanent uterine artery occlusion is necessary to optimally treat uterine fibroids. Despite high rates of uterine artery recanalization in this cohort, satisfactory fibroid infarction rates and UFS-QOL scores were achieved

  20. MRI Assessment of Uterine Artery Patency and Fibroid Infarction Rates 6 Months after Uterine Artery Embolization with Nonspherical Polyvinyl Alcohol

    Energy Technology Data Exchange (ETDEWEB)

    Das, Raj, E-mail: rajdas@nhs.net; Gonsalves, Michael; Vlahos, Ioannis [St George' s Healthcare NHS Trust, Blackshaw, Department of Radiology (United Kingdom); Manyonda, Issac [St George' s Healthcare NHS Trust, Department of Gynaecology (United Kingdom); Belli, Anna-Maria [St George' s Healthcare NHS Trust, Blackshaw, Department of Radiology (United Kingdom)

    2013-10-15

    Purpose: We have observed significant rates of uterine artery patency after uterine artery embolization (UAE) with nonspherical polyvinyl alcohol (nsPVA) on 6 month follow-up MR scanning. The study aim was to quantitatively assess uterine artery patency after UAE with nsPVA and to assess the effect of continued uterine artery patency on outcomes. Methods: A single centre, retrospective study of 50 patients undergoing bilateral UAE for uterine leiomyomata was undertaken. Pelvic MRI was performed before and 6 months after UAE. All embolizations were performed with nsPVA. Outcome measures included uterine artery patency, uterine and dominant fibroid volume, dominant fibroid percentage infarction, presence of ovarian arterial collaterals, and symptom scores assessed by the Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL). Results: Magnetic resonance angiographic evidence of uterine artery recanalization was demonstrated in 90 % of the patients (64 % bilateral, 26 % unilateral) at 6 months. Eighty percent of all dominant fibroids demonstrated >90 % infarction. The mean percentage reduction in dominant fibroid volume was 35 %. No significant difference was identified between nonpatent, unilateral, and bilateral recanalization of the uterine arteries with regard to percentage dominant fibroid infarction or dominant fibroid volume reduction. The presence of bilaterally or unilaterally patent uterine arteries was not associated with inferior clinical outcomes (symptom score or UFS-QOL scores) at 6 months. Conclusion: The high rates of uterine artery patency challenge the current paradigm that nsPVA is a permanent embolic agent and that permanent uterine artery occlusion is necessary to optimally treat uterine fibroids. Despite high rates of uterine artery recanalization in this cohort, satisfactory fibroid infarction rates and UFS-QOL scores were achieved.

  1. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.

    Science.gov (United States)

    Shepherd, Deborah M; Jahnke, Heidi; White, William L; Little, Andrew S

    2018-02-01

    OBJECTIVE Pain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo. METHODS This study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0-10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs). RESULTS Of 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid use compared with placebo. Postoperative multimodal pain management, including a nonsteroidal antiinflammatory medication, should be considered after surgery to improve patient comfort and to limit opioid use. Clinical trial registration no.: NCT02351700 (clinicaltrials

  2. Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

    Directory of Open Access Journals (Sweden)

    Russell Dianne

    2007-09-01

    Full Text Available Abstract Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, activities (performance of functional tasks, motor function, participation (involvement in formal and informal activities, and environment (parent

  3. Invasive placenta previa: Placental bulge with distorted uterine outline and uterine serosal hypervascularity at 1.5T MRI - useful features for differentiating placenta percreta from placenta accreta.

    Science.gov (United States)

    Chen, Xin; Shan, Ruiqin; Zhao, Lianxin; Song, Qingxu; Zuo, Changting; Zhang, Xinjuan; Wang, Shanshan; Shi, Honglu; Gao, Fei; Qian, Tianyi; Wang, Guangbin; Limperopoulos, Catherine

    2018-02-01

    To characterise MRI features of invasive placenta previa and to identify specific features for differentiating placenta percreta (PP) from placenta accreta (PA). Forty-five women with PP and 93 women with PA who underwent 1.5T placental MRI were included. Two radiologists independently evaluated the MRI features of invasive placenta previa, including our novel type of placental bulge (i.e. placental bulge type-II, characterized by placental bulge with distorted uterine outline). Pearson's chi-squared or Fisher's two-sided exact test was performed to compare the MRI features between PP and PA. Logistic stepwise regression analysis and the area under the receiver operating characteristic curve (AUC) were performed to select the optimal features for differentiating PP from PA. Significant differences were found in nine MRI features between women with PP and those with PA (P Placental bulge type-II and uterine serosal hypervascularity were independently associated with PP (odds ratio = 48.618, P Placental bulge type-II and uterine serosal hypervascularity are useful MRI features for differentiating PP from PA. • Placental bulge type-II demonstrated the strongest independent association with PP. • Uterine serosal hypervascularity is a useful feature for differentiating PP from PA. • MRI features associated with abnormal vessels increase the risk of massive haemorrhage.

  4. Use of ICD-10 codes to monitor uterine rupture

    DEFF Research Database (Denmark)

    Thisted, Dorthe L A; Mortensen, Laust Hvas; Hvidman, Lone

    2014-01-01

    OBJECTIVES: Uterine rupture is a rare but severe complication in pregnancies after a previous cesarean section. In Denmark, the monitoring of uterine rupture is based on reporting of relevant diagnostic codes to the Danish Medical Birth Registry (MBR). The aim of our study was to examine the vali......OBJECTIVES: Uterine rupture is a rare but severe complication in pregnancies after a previous cesarean section. In Denmark, the monitoring of uterine rupture is based on reporting of relevant diagnostic codes to the Danish Medical Birth Registry (MBR). The aim of our study was to examine...... uterine ruptures, the sensitivity and specificity of the codes for uterine rupture were 83.8% and 99.1%, respectively. CONCLUSION: During the study period the monitoring of uterine rupture in the MBR was inadequate....

  5. Area detection of uterine peristalsis using cine-MR images

    International Nuclear Information System (INIS)

    Sato, Tetsuo; Fujita, Nao; Nakai, Asako; Togashi, Kaori; Kuhara, Shigehide; Okada, Tomohisa

    2011-01-01

    In this paper, a technique for evaluating uterine peristalsis obtained by magnetic resonance images is proposed. Uterine peristalsis is the wavelike movement of uterine muscle contractions with rhythm and direction. Correlation between direction of uterine peristalsis and menstrual cycle has been reported, which is supposed to help sperm transpotation and implantation. While evaluation of uterine peristalsis has been done, they are very subjective and no quantitative evaluation has been established. In the proposed method the peristalsis area and their contraction intensity were calculated. The points of uterine peristalsis was estimated by the spatio-temporal map, which reflect the time series behavior of the intensities around points set on uterine endometrial boundaries. Then peristalsis area was decided as the estimated points. The contraction intensity was defined as the ratio of the signal intensity change in the peristalsis area. (author)

  6. A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults

    Science.gov (United States)

    Thiele, Jill; Nimmo, Rachel; Rowell, Wendy; Quinn, Stephen; Jones, Graeme

    2009-01-01

    Background To compare the effectiveness of a custom-made leather wrist splint (LS) with a commercially available fabric splint (FS) in adults with chronic wrist pain. Methods Participants (N = 25, mean age = 54) were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the Canadian Occupational Performance Measure (COPM) and Jamar dynamometer by an observer blinded to treatment allocation. Results Both styles of wrist splint significantly reduced pain (effect size LS 0.79, FS 0.43), improved hand function and increased grip strength compared to baseline (all p leather splint compared to the commercially available splint. Conclusion Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction. PMID:19843345

  7. Report of a randomized trial of d(15)+Be neutrons compared with megavoltage X ray therapy of bladder cancer

    International Nuclear Information System (INIS)

    Duncan, W.; Arnott, S.J.; Jack, W.J.; MacDougall, R.H.; Quilty, P.M.; Rodger, A.; Kerr, G.R.; Williams, J.R.

    1985-01-01

    The results of a randomized trial of d(15)+Be neutrons compared with 4 or 6 MV photons for the treatment of transitional cell carcinoma of the bladder. Between December 1978 and December 1981, 113 patients were accrued, 53 allocated to be treated by neutrons and 60 by photons. Complete local tumor regression was observed in 64% of patients treated by neutrons and 62% treated by photons. Recurrent cancer was subsequently confirmed in 31% of patients, similar in both treatment groups. There was no significant difference in the control rates by T stage between the two treatment groups. Late morbidity was significantly worse in patients treated by neutrons. Following neutron therapy, 78% of patients had serious late morbidity in at least one tissue compared with 38% in the group treated by photons. Survival was significantly better in the photon treated group 45.3% (+/- 11%) at 5 years compared with 12% (+/- 6%) after neutron therapy

  8. Relative Effectiveness of Letrozole Compared With Tamoxifen for Patients With Lobular Carcinoma in the BIG 1-98 Trial

    DEFF Research Database (Denmark)

    Metzger Filho, Otto; Giobbie-Hurder, Anita; Mallon, Elizabeth

    2015-01-01

    assigned onto the Breast International Group (BIG) 1-98 trial and who had centrally reviewed pathology data were included (N = 2,923). HER2-negative IDC and ILC were additionally classified as hormone receptor-positive with high (luminal B [LB] -like) or low (luminal A [LA] -like) proliferative activity......PURPOSE: To evaluate the relative effectiveness of letrozole compared with tamoxifen for patients with invasive ductal or lobular carcinoma. PATIENTS AND METHODS: Patients diagnosed with early-stage invasive ductal carcinoma (IDC) or classic invasive lobular carcinoma (ILC) who were randomly...

  9. At what price? A cost-effectiveness analysis comparing trial of labour after previous Caesarean versus elective repeat Caesarean delivery.

    LENUS (Irish Health Repository)

    Fawsitt, Christopher G

    2013-01-01

    Elective repeat caesarean delivery (ERCD) rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland.

  10. A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

    Science.gov (United States)

    2015-10-01

    score >45. Exclusion criteria: Service related trauma within last 3 months, history of schizophrenia, bipolar disorder , dementia, moderate or severe...7.7% 0.0% 8.3% 0.191 Bipolar disorder , % 7.7% 10.3% 13.9% 0.681 Substance use disorder , % 30.8% 43.6% 41.7% 0.458 Major depressive disorder ...Award Number: W81XWH-12-1-0576 TITLE: A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in

  11. Effect of Modified and accumulated decoction on serum ER, PR, sex hormone, IGF-I and IGF-I in patients with uterine fibroids

    Directory of Open Access Journals (Sweden)

    Yi-Sha Li

    2017-11-01

    Full Text Available Objective: To study the effect of Modified and accumulated Decoction on serum ER, PR, sex hormone, IGF-I and IGF-I in patients with uterine fibroids. Method: A total of 90 patients with uterine fibroids in our hospital from January 2015 to January 2017 were enrolled in this study. The subjects were divided into the control group (n=45 and the treatment group (n=45 randomly. The control group was treated with mifepristone, the treatment group was treated with Modified and accumulated Decoction combined with mifepristone, and both the two groups were treated for 3 months. The uterine fibroid volume and uterine volume of the two groups before and after treatment were compared. The serum ER, PR, P, E 2 , LH, FSH, IGF-I and IGF-IR of the two groups before and after treatment were compared. Result: There were no significantly differences of the uterine fibroid volume and uterine volume of the two groups before treatment. The uterine fibroid volume and uterine volume of the two groups after treatment were significantly less than before treatment, and that of the treatment group after treatment were significantly less than the control group. There were no significantly differences among the serum ER, PR, P, E 2 , LH, FSH, IGF-I and IGF-IR of the two groups before treatment. The serum ER, PR, P, E 2 , LH, FSH, IGF-I and IGF-IR of the two groups after treatment were significantly lower than before treatment, and that of the treatment group after treatment were significantly lower than the control group. Conclusion: Modified and accumulated Decoction combined with mifepristonecan significantly reduce the uterine fibroid volume, improve the serum ER, PR, sex hormone, IGF-I and IGF-I levels of the patients with uterine fibroids, and it was worthy clinical application.

  12. Intra-uterine hematoma in pregnancy

    DEFF Research Database (Denmark)

    Glavind, K; Nøhr, S; Nielsen, P H

    1991-01-01

    In 60 patients with a live fetus and an intra-uterine hematoma (IUH) proven by ultrasonic scanning the outcome of pregnancy was spontaneous abortion in 12% and premature delivery in 10%. No correlation between the outcome of the pregnancy and the maximum size of the hematoma or the week...

  13. CORRELATION BETWEEN UTERINE ARTERY FLOW VELOCITY ...

    African Journals Online (AJOL)

    CORRELATION BETWEEN UTERINE ARTERY FLOW VELOCITY WAVEFORMS AND ENDOMETRIAL HISTOPATHOLOGY IN WOMEN WITH PERIMENOPAUSAL AND POSTMENOPAUSAL BLEEDING. Dr. Ebtesam Saied, Dr. Ismail El Garhy(MD), Dr. Farid I. Hassan(MD), Dr. Adel-Gamil Abd-Allah, Abd El Shafy Ibrahim ...

  14. Intra-uterine insemination for male subfertility

    NARCIS (Netherlands)

    Bensdorp, A. J.; Cohlen, B. J.; Heineman, M. J.; Vandekerckhove, P.

    2007-01-01

    BACKGROUND: Intra-uterine insemination (IUI) is one of the most frequently used fertility treatments for couples with male subfertility. Its use, especially when combined with ovarian hyperstimulation (OH) has been subject of discussion. Although the treatment itself is less invasive and expensive

  15. Dysfunctional uterine bleedings of a climacteric period

    International Nuclear Information System (INIS)

    Prilepskaya, V.N.

    1993-01-01

    Climacteric period of some women is complicated by dysfunctional uterine bleedings (DUB). Bearing in mind the fact that DUBS are caused by disorder of estrin rhysmic secretion, the paper presents the methods of differential diagnostics for investigations into functional disorders in the hypothalamus -hypophysis - ovaries - uterus system. The preference is given to roentgenologic and radioimmunologic diagnostic methods

  16. A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D.

    Science.gov (United States)

    Eswaran, Shanti L; Chey, William D; Han-Markey, Theresa; Ball, Sarah; Jackson, Kenya

    2016-12-01

    There has been an increasing interest in the role of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) in irritable bowel syndrome (IBS). We report results from the first randomized controlled trial of the low FODMAP diet in US adults with IBS and diarrhea (IBS-D). The objectives were to compare the efficacy of the low FODMAP diet vs. a diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) on overall and individual symptoms in IBS-D patients. This was a single-center, randomized-controlled trial of adult patients with IBS-D (Rome III) which compared 2 diet interventions. After a 2-week screening period, eligible patients were randomized to a low FODMAP or mNICE diet for 4 weeks. The primary end point was the proportion of patients reporting adequate relief of IBS-D symptoms ≥50% of intervention weeks 3-4. Secondary outcomes included a composite end point which required response in both abdominal pain (≥30% reduction in mean daily pain score compared with baseline) and stool consistency (decrease in mean daily Bristol Stool Form of ≥1 compared with baseline), abdominal pain and stool consistency responders, and other key individual IBS symptoms assessed using daily questionnaires. After screening, 92 subjects (65 women, median age 42.6 years) were randomized. Eighty-four patients completed the study (45 low FODMAP, 39 mNICE). Baseline demographics, symptom severity, and nutrient intake were similar between groups. Fifty-two percent of the low FODMAP vs. 41% of the mNICE group reported adequate relief of their IBS-D symptoms (P=0.31). Though there was no significant difference in the proportion of composite end point responders (P=0.13), the low FODMAP diet resulted in a higher proportion of abdominal pain responders compared with the mNICE group (51% vs. 23%, P=0.008). Compared with baseline scores, the low FODMAP diet led to greater reductions in average daily scores of abdominal pain, bloating

  17. Expanding the Evidence Base: Comparing Randomized Controlled Trials and Observational Studies of Statins.

    Science.gov (United States)

    Atar, Dan; Ong, Seleen; Lansberg, Peter J

    2015-01-01

    It is widely accepted that randomized controlled trials (RCTs) are the gold standard for demonstrating the efficacy of a given therapy (results under ideal conditions). Observational studies, on the other hand, can complement this by demonstrating effectiveness (results under real-world conditions). To examine the role that observational studies can play in complementing data from RCTs, we reviewed published studies for statins, a class of drugs that have been widely used to reduce the risk of cardiovascular (CV) events by lowering low-density lipoprotein cholesterol levels. RCTs have consistently demonstrated the benefits of statin treatment in terms of CV risk reduction and have demonstrated that more intensive statin therapy has incremental benefits over less intensive treatment. Observational studies of statin use in 'real-world' populations have served to augment the evidence base generated from statin RCTs in preselected populations of patients who are often at high CV risk and have led to similar safety and efficacy findings. They have also raised questions about factors affecting medication adherence, under-treatment, switching between statins, and failure to reach low-density lipoprotein cholesterol target levels, questions for which the answers could lead to improved patient care.

  18. Anastomoses of the Ovarian and Uterine Arteries: A Potential Pitfall and Cause of Failure of Uterine Embolization

    International Nuclear Information System (INIS)

    Matson, Matthew; Nicholson, Anthony; Belli, Anna-Maria

    2000-01-01

    Four women with symptomatic uterine fibroids were treated by uterine artery embolization (UAE). In all cases both uterine arteries were embolized via a single femoral puncture with polyvinyl alcohol using a selective catheter technique. In three cases, the ovarian artery was not visible on the initial angiogram before embolization, but appeared after the second uterine artery had been treated. In one case of clinical failure following UAE, a repeat angiogram demonstrated filling of the fibroids from the ovarian artery. Anastomoses between uterine and ovarian arteries may cause problems for radiologists performing UAE and are a potential cause of treatment failure

  19. The Role of Adjuvant Radiation in Uterine Sarcomas

    International Nuclear Information System (INIS)

    Sampath, Sagus; Schultheiss, Timothy E.; Ryu, Janice K.; Wong, Jeffrey Y.C.

    2010-01-01

    Purpose: To determine clinical and pathological factors significant for overall survival (OS) and local-regional failure-free survival (LRFFS) in uterine sarcoma as they relate to adjuvant radiotherapy (AR). Methods and Materials: A retrospective analysis of 3,650 patients with uterine sarcoma was conducted using the National Oncology Database, a proprietary database of aggregated tumor registries owned by Impac Medical Systems (Sunnyvale, CA). Adjuvant radiotherapy was defined as postoperative external beam radiation to the pelvis, with or without brachytherapy. Prognostic factors were identified by multivariate analysis (MVA) using the Cox proportional hazards model. The Kaplan-Meier method was used to estimate survival, with significant differences (p < 0.05) determined using the log-rank test. Results: The median follow-up time was 59 months, with a 5-year OS of 37%. Significant prognostic factors for OS were stage, race/ethnicity, grade, age, histology, lymph node status, and surgical treatment (p < 0.01 for all factors). Use of AR was not predictive for OS. For nonmetastatic cancer patients receiving definitive surgery (n = 2,206), the 5-year LRFFS was 87%. In this group, stage, grade, histology, and AR were prognostic for LRFFS (p < 0.05), with AR associated with improved outcome compared with surgery alone (hazard ratio = 0.4, p < 0.001). Patients with carcinosarcoma, endometrial stromal sarcoma, leiomyosarcoma, poorly differentiated tumors, and negative lymph nodes had reduced local-regional failure (LRF) with AR (log-rank, p < 0.05 for all). Conclusion: In the largest retrospective analysis of uterine sarcoma published thus far, AR conferred a 53% reduction in the risk of LRF at 5 years. Use of AR may have broader indications than what are currently accepted in clinical practice.

  20. 18F-fluorodeoxyglucose positron emission tomography in uterine carcinosarcoma

    International Nuclear Information System (INIS)

    Ho, Kung-Chu; Yen, Tzu-Chen; Lai, Chyong-Huey; Wu, Tzu-I; Chang, Ting-Chang; Huang, Huei-Jean; Ng, Koon-Kwan; Lin, Gigin; Wang, Chun-Chieh; Hsueh, Swei

    2008-01-01

    Uterine carcinosarcomas clinically confined to the uterus usually harbor occult metastases. We conducted a pilot study to evaluate the value of 18 F-fluorodeoxyglucose (FDG) positron emission tomography (PET) in uterine carcinosarcoma. Patients with histologically confirmed uterine carcinosarcoma were enrolled. Abdominal and pelvic magnetic resonance imaging (MRI)/whole-body computed tomogra