Which Should Be the Preferred Technique During Laparoscopic Ovarian Cystectomy: Hemostatic Sutures or Bipolar Electrocoagulation? A Randomized Controlled Prospective Study of Long-Term Ovarian Reserve

Abstract Background: Endometriosis (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 removal of a part of the normal ovarian tissue and thermal damage during hemostasis, which depends on 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.Methods: This 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 minutes, and adverse events associated with operation. Discussion: We 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 registration: ClinicalTrials.gov: NCT04643106. Registered on 22 November 2020.

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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 ◽

10.1186/s13063-021-05431-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Hyunji Lim ◽

Soo Jin Park ◽

Haerin Paik ◽

Jaehee Mun ◽

Eun Ji Lee ◽

...

Keyword(s):

Protective Effect ◽

Pelvic Pain ◽

Ovarian Reserve ◽

Reduction Rate ◽

Hemostatic Agent ◽

Barbed Suture ◽

Ovarian Cystectomy ◽

Randomized Controlled ◽

Link Type ◽

Bipolar Electrocoagulation

Abstract Background Endometriosis (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. Methods This 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. Discussion We 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 registration ClinicalTrials.govNCT04643106. Registered on 22 November 2020

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The Effect of Bipolar Electrocoagulation During Ovarian Cystectomy on Ovarian Reserve

Obstetrical & Gynecological Survey ◽

10.1097/01.ogx.0000483291.17462.51 ◽

2016 ◽

Vol 71 (5) ◽

pp. 292

Author(s):

Vasilios Pergialiotis ◽

Anastasia Prodromidou ◽

Maximos Frountzas ◽

Konstantinos Bitos ◽

Despina Perrea ◽

...

Keyword(s):

Ovarian Reserve ◽

Ovarian Cystectomy ◽

Bipolar Electrocoagulation

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A randomized controlled trial of ovarian reserve preservation and hemostasis during ovarian cystectomy

Scientific Reports ◽

10.1038/s41598-021-87965-7 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Soo Jin Park ◽

◽

Aeran Seol ◽

Nara Lee ◽

Seungmee Lee ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Ovarian Cyst ◽

Ovarian Reserve ◽

Controlled Trial ◽

Reproductive Age ◽

Hemostatic Agent ◽

Cyst Excision ◽

Hemostatic Agents ◽

Ovarian Cystectomy ◽

Randomized Controlled

AbstractThe preservation of ovarian reserve during laparoendoscopic single-site (LESS) ovarian cystectomy is crucial for reproductive-age women. This study was a single-blinded, single-center, and randomized controlled trial to evaluate the effect of hemostatic agents on the preservation of ovarian reserve and hemostasis during LESS ovarian cystectomy. Patients with unilateral ovarian cyst were randomized to the hemostatic agent and coagulation groups according to the hemostasis method. Afterwards, the patients underwent LESS ovarian cystectomy, and hemostasis was performed after ovarian cyst excision according to the assigned hemostasis method. If hemostasis was not completed within 10 min. After discharge, the patients were followed until 3 months after surgery. We compared the hemoglobin, anti-Müllerian hormone (AMH) levels, and ovarian volumes before surgery, and 2 days, 1 week, and 3 months after surgery (3 M-POST), and the decline ratio between the two groups. The decline ratio of serum AMH levels was greater at 3 M-POST in the coagulation than in the hemostatic agent group (median intention-to-treat [ITT], − 36.7 vs. − 13.3%; per-protocol [PP], − 36.8 vs. − 13.3%; P < 0.05). Notably, the difference of the decline ratio of serum AMH levels was only shown in endometriosis patients (median; ITT, − 50.7 vs. − 14.4%; PP, − 50.7% vs. − 14.4%; P < 0.05), while there was no difference in non-endometriosis patients. In conclusion, Hemostatic agents may be non-inferior to bipolar coagulation for preserving ovarian reserve and hemostasis during LESS ovarian cystectomy, in particular, for endometriosis patients. (Trial registry: ClinicalTrials.gov Identifier NCT03374397).

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