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

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ژورنال

عنوان ژورنال: Trials

سال: 2021

ISSN: ['1745-6215']

DOI: https://doi.org/10.1186/s13063-021-05431-1