Preservation of the ovarian reserve and hemostasis during laparoscopic ovarian cystectomy by a hemostatic agent versus suturing for patients with ovarian endometriosis: study protocol for randomized controlled, non-inferiority trial (PRAHA-2 trial)
نویسندگان
چکیده
Abstract Background Endometriosis (EMS) can be implanted everywhere, especially in pelvic organs. EMS asymptomatic, but it result pain and infertility by inducing local inflammation adhesion. The prevalence of is about 10% reproductive-age women higher with or infertility. For young patients ovarian EMS, laparoscopic cystectomy effective relieving preventing recurrence. However, there a concern that the reserve would decrease after operation because removal part normal tissue thermal damage during hemostasis, which depends on types hemostasis such as bipolar electrocoagulation, suturing, use hemostatic agent. In this study, we aim to evaluate protective effect for between agent suturing EMS. Methods This study randomized controlled, non-inferiority trial, where total 90 will randomly assigned experimental (hemostatic agent) control (suturing) groups. group, barbed suture applied whereas group. If two methods are insufficient, electrocoagulation complete hemostasis. As primary endpoint, reduction rate serum anti- Müllerian hormone (AMH) levels reflecting compared groups 12 weeks surgery. secondary endpoints, compare AMH level 48 surgery, time required success within 10 min, adverse events associated operation. Discussion We expect may comparable methods, suggesting preferred considering easy cystectomy. Trial registration ClinicalTrials.gov NCT04643106 . Registered 22 November 2020
منابع مشابه
Additional benefit of hemostatic sealant in preservation of ovarian reserve during laparoscopic ovarian cystectomy: a multi-center, randomized controlled trial.
STUDY QUESTION Is hemostasis by hemostatic sealant superior to that achieved by bipolar coagulation in preserving ovarian reserve in patients undergoing laparoscopic ovarian cystectomy? SUMMARY ANSWER Post-operative ovarian reserve, determined by serial serum anti-Müllerian hormone (AMH) levels, was significantly less diminished after ovarian hemostasis when hemostatic sealant was used rather...
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Evaluation of factors predicting diminished ovarian reserve before and after laparoscopic cystectomy for ovarian endometriomas: a prospective cohort study
BACKGROUND Ovarian endometriomas affect a substantial proportion of women of reproductive age who may have a potential risk of diminished ovarian reserve (DOR) after ovarian cystectomy. Here, we investigated the risk factors for pre-surgical DOR in patients with ovarian endometriomas and for DOR after laparoscopic ovarian cystectomy for endometriomas and evaluated the feasibility of the pre-sur...
متن کاملComparing long term impact on ovarian reserve between laparoscopic ovarian cystectomy and open laprotomy for ovarian endometrioma
OBJECTIVE To compare the long term impact on ovarian reserve between laparoscopic ovarian cystectomy with bipolar electrocoagulation and laparotomic cystectomy with suturing for ovarian endometrotic cyst. PATIENT AND METHOD(S) 121 patients with benign ovarian endometroitic cysts were randomised to either laparoscopic ovarian cystectomy using bipolar electrocoagulation (61 patients) or laparot...
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ژورنال
عنوان ژورنال: Trials
سال: 2021
ISSN: ['1745-6215']
DOI: https://doi.org/10.1186/s13063-021-05431-1