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)

Trials

Whasun Lim¹  Seungmee Lee²  Ga Won Yim³  Chae Hyeong Lee³  Seung-Hyuk Shim⁴  Hee Seung Kim⁵  Soo Jin Park⁵  Haerin Paik⁵  Hyunji Lim⁵  Jaehee Mun⁵  Eun Ji Lee⁵  Gwonhwa Song⁶ 

[1] Department of Food and Nutrition, Kookmin University, 02707, Seoul, Republic of Korea;Department of Obstetrics & Gynecology, Keimyung University School of Medicine, 41931, Daegu, Republic of Korea;Department of Obstetrics and Gynecology, Dongguk University Ilsan Hospital, 10326, Goyang, Republic of Korea;Department of Obstetrics and Gynecology, Konkuk University Medical center, 05030, Seoul, Republic of Korea;Department of Obstetrics and Gynecology, Seoul National University Hospital, 101 Daehak-Ro, Jongno-Gu, 03080, Seoul, Republic of Korea;Institute of Animal Molecular Biotechnology and Department of Biotechnology, College of Life Sciences and Biotechnology, Korea University, 02841, Seoul, Republic of Korea;

关键词: Endometriosis;    Laparoscopic ovarian cystectomy;    Ovarian reserve;    Hemostatic agent;    Suturing;   

DOI  :  10.1186/s13063-021-05431-1

来源: Springer

【 摘 要 】

BackgroundEndometriosis (EMS) can be implanted everywhere, especially in pelvic organs. EMS can be asymptomatic, but it can result in pelvic pain and infertility by inducing local inflammation and pelvic adhesion. The prevalence of EMS is about 10% in reproductive-age women and higher in women with pelvic pain or infertility. For young patients with ovarian EMS, laparoscopic ovarian cystectomy is effective in relieving pelvic pain and preventing local recurrence. However, there is a concern that the ovarian reserve would decrease after the operation because of the removal of a part of the normal ovarian tissue and thermal damage during hemostasis, which depends on the types of hemostasis such as bipolar electrocoagulation, suturing, and the use of a hemostatic agent. In this study, we aim to evaluate the protective effect for the ovarian reserve and hemostasis between a hemostatic agent and suturing during laparoscopic ovarian cystectomy for patients with ovarian EMS.MethodsThis study is a randomized controlled, non-inferiority trial, where a total of 90 patients with ovarian EMS will be randomly assigned to the experimental (hemostatic agent) and control (suturing) groups. In the control group, a barbed suture will be applied for hemostasis, whereas a hemostatic agent will be applied in the experimental group. If two methods are insufficient, bipolar electrocoagulation will be applied for complete hemostasis. As the primary endpoint, the reduction rate of serum anti- Müllerian hormone (AMH) levels reflecting the ovarian reserve will be compared between the two groups 12 weeks after surgery. As secondary endpoints, we will compare the reduction rate of AMH level 48 weeks after surgery, the time required to complete hemostasis, the success rate of hemostasis within 10 min, and adverse events associated with operation.DiscussionWe expect that the protective effect for the ovarian reserve and hemostasis may be comparable between the two methods, suggesting that a hemostatic agent may be preferred considering that it is easy to use during laparoscopic ovarian cystectomy.Trial registrationClinicalTrials.govNCT04643106. Registered on 22 November 2020

【 授权许可】

CC BY