Anti-adhesion therapy following operative hysteroscopy for treatment of female subfertility.
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ABSTRACT:
SUBMITTER: Bosteels J
PROVIDER: S-EPMC6486292 | biostudies-literature | 2017 Nov
REPOSITORIES: biostudies-literature
Publications
Anti-adhesion therapy following operative hysteroscopy for treatment of female subfertility.
Bosteels Jan J Weyers Steven S D'Hooghe Thomas M TM Torrance Helen H Broekmans Frank J FJ Chua Su Jen SJ Mol Ben Willem J BWJ
The Cochrane database of systematic reviews 20171127
<h4>Background</h4>Observational evidence suggests a potential benefit with several anti-adhesion therapies in women undergoing operative hysteroscopy (e.g. insertion of an intrauterine device or balloon, hormonal treatment, barrier gels or human amniotic membrane grafting) for decreasing intrauterine adhesions (IUAs).<h4>Objectives</h4>To assess the effectiveness of anti-adhesion therapies versus placebo, no treatment or any other anti-adhesion therapy, following operative hysteroscopy for trea ...[more]
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Project description:Study questionsDoes the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth?What is known alreadyIntrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality.Study design size durationThis multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%.Participants/materials setting methodsWomen of reproductive age (18-47?years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6?weeks after receiving allocated treatment with follow-up ending at 30?weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2-6?weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30?weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30?weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester.Study funding/competing interestsThis work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.
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Project description:Background:Many surgeons advocate for surgical intervention of adult mallet fractures that involve either subluxation of the distal interphalangeal (DIP) joint or those that involve more than one-third of the articular surface. However, the efficacy of operative treatment and complication rates are unclear regarding the adolescent population. Questions/Purposes:The goal of this study is to evaluate the clinical outcomes following operative fixation of bony mallet fractures in the adolescent population. Methods:Seventeen patients with bony mallet fractures treated surgically were retrospectively reviewed. Twelve patients were treated by closed reduction with extension block pinning. The other patients underwent an open reduction and pin fixation. The average age was 15.2 years (13-18). Most injuries were sport related. The average time from injury to presentation was 17 days and from injury to surgery was 24.5 days. Nine patients had subluxation at the DIP joint and all involved at least one-third of the articular surface. Results:The average time from surgery to pin removal was 28 days (19-46). All distal phalanx physis were closed or nearly closed. One patient reported pain at the final follow-up. Two patients (11.8%) had major complications. One had an extension contracture postoperatively, did not attend therapy, and re-fractured 5 months later requiring reoperation. The second was treated delayed (32 days) and lost fixation, requiring revision surgery and antibiotics for a superficial infection. Two patients with delayed treatment (32 and 44 days) had an extensor lag (11.8%). Conclusions:Operative treatment of mallet fractures with subluxation or involving more than one-third of the articular surface appears effective. Pin removal 4 weeks postoperatively appears adequate. Complications occurred with delayed presentation and non-compliance.
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Project description:ImportanceVacuum aspiration is commonly used to remove retained products of conception in patients with incomplete spontaneous abortion. Scarring of the uterine cavity may occur, potentially impairing future fertility. A procedural alternative, operative hysteroscopy, has gained popularity with a presumption of better future fertility.ObjectiveTo assess the superiority of hysteroscopy to vacuum aspiration for subsequent pregnancy in patients with incomplete spontaneous abortion who intend to have future pregnancy.Design, setting, and participantsThe HY-PER randomized, controlled, single-blind trial included 574 patients between November 6, 2014, and May 3, 2017, with a 2-year duration of follow-up. This multicenter trial recruited patients in 15 French hospitals. Individuals aged 18 to 44 years and planned for surgery for an incomplete spontaneous abortion with plans to subsequently conceive were randomized in a 1:1 ratio.InterventionsSurgical treatment by hysteroscopy (n = 288) or vacuum aspiration (n = 286).Main outcomes and measuresThe primary outcome was a pregnancy of at least 22 weeks' duration during 2-year follow-up.ResultsThe intention-to-treat analyses included 563 women (mean [SD] age, 32.6 [5.4] years). All aspiration procedures were completed. The hysteroscopic procedure could not be completed for 19 patients (7%), 18 of which were converted to vacuum aspiration (8 with inability to completely resect, 7 with insufficient visualization, 2 with anesthetic complications that required a shortened procedure, 1 with equipment failure). One hysteroscopy failed due to a false passage during cervical dilatation. During the 2-year follow-up, 177 patients (62.8%) in the hysteroscopy group and 190 (67.6%) in the vacuum aspiration (control) group achieved the primary outcome (difference, -4.8% [95% CI, -13% to 3.0%]; P = .23). The time-to-event analyses showed no statistically significant difference between groups for the primary outcome (hazard ratio, 0.87 [95% CI, 0.71 to 1.07]). Duration of surgery and hospitalization were significantly longer for hysteroscopy. Rates of new miscarriages, ectopic pregnancies, Clavien-Dindo surgical complications of grade 3 or above (requiring surgical, endoscopic, or radiological intervention or life-threatening event or death), and reinterventions to remove remaining products of conception did not differ between groups.Conclusions and relevanceSurgical management by hysteroscopy of incomplete spontaneous abortions in patients intending to conceive again was not associated with more subsequent births or a better safety profile than vacuum aspiration. Moreover, operative hysteroscopy was not feasible in all cases.Trial registrationClinicalTrials.gov Identifier: NCT02201732.
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