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Epinephrine minimizes the use of bipolar coagulation and preserves ovarian reserve in laparoscopic ovarian cystectomy: a randomized controlled trial.

ABSTRACT: We propose a novel method, the epinephrine compression method (Epi-pledget), as a hemostasis method for ovarian cystectomy. A total of 179 patients undergoing laparoscopic ovarian cystectomy with stripping were randomly allocated into three groups: the bipolar coagulation group, the Epi-pledget group, and the coagulation after Epi-pledget (Epi & Coagulation) group. Serum anti-Müllerian hormone (AMH) levels and antral follicle count (AFC) by ultrasonography were measured to determine the preservation of ovarian function. To evaluate the postoperative ovarian cellular proliferative activity and tissue damage in a mouse model, we operated on the ovaries of mice with an artificial incision injury and applied two hemostatic methods: coagulation and Epi-pledget. Eight weeks after surgery, the AMH rate significantly decreased in the bipolar coagulation group compared with the Epi-pledget group. The AFC decline rate was also significantly greater in the coagulation group than the Epi-pledget group. Specifically, patients with endometrioma had a significantly greater decline of serum AMH in the coagulation group than the Epi-pledget group. In a histopathological analysis in mice, the Epi-pledget group showed ameliorated fibrotic changes and necrotic findings in the injured lesion compared with the bipolar coagulation group. The Epi-pledget method for ovarian stripping has an additional benefit of maximizing the preservation of the ovarian reserve, especially for the endometriotic ovarian cyst type.

SUBMITTER: Park EY

PROVIDER: S-EPMC7708492 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Epinephrine minimizes the use of bipolar coagulation and preserves ovarian reserve in laparoscopic ovarian cystectomy: a randomized controlled trial.

Park Eun Young EY Hwang Kyu-Hee KH Kim Ji-Hee JH Lee San-Hui SH Park Kyu-Sang KS Choi Seong Jin SJ Cha Seung-Kuy SK

Scientific reports 20201201 1

We propose a novel method, the epinephrine compression method (Epi-pledget), as a hemostasis method for ovarian cystectomy. A total of 179 patients undergoing laparoscopic ovarian cystectomy with stripping were randomly allocated into three groups: the bipolar coagulation group, the Epi-pledget group, and the coagulation after Epi-pledget (Epi & Coagulation) group. Serum anti-Müllerian hormone (AMH) levels and antral follicle count (AFC) by ultrasonography were measured to determine the preserva ...[more]

PMID: 33262411

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Project description: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.gov NCT04643106 . Registered on 22 November 2020.

Project description:STUDY QUESTION:Does CO2 laser vaporization offer better results in treating endometrioma in terms of ovarian reserve preservation compared to traditional cystectomy? SUMMARY ANSWER:Assessing both antral follicle count (AFC) and serum anti-Müllerian hormone (AMH) levels as measures of ovarian reserve, the results suggest that CO2 technology may be an alternative treatment for endometrioma, causing minimal damage to adjacent healthy ovarian tissue. WHAT IS KNOWN ALREADY:Excisional surgery has been questioned as an ideal surgical approach for endometriomas because it is associated with potential reduction of ovarian reserve. Recently, vaporization with CO2 laser in-line-of-sight, according to the 'three-step procedure', has been proposed as the best method to preserve ovarian function. However, no randomized controlled trials have been conducted to compare cystectomy and 'one-step' CO2 fiber laser vaporization (without GnRH agonist therapy) with respect to the ovarian reserve. STUDY DESIGN, SIZE, DURATION:A multicentre randomized clinical trial including 60 patients was performed between July 2017 and February 2018. Computerized randomization was conducted to allocate them in a proportion of 1:1 either to Group 1 (laparoscopic stripping: cystectomy) or Group 2 (CO2 laser vaporization). Patients in Group 1 underwent a standardized laparoscopic stripping technique; patients in Group 2 underwent drainage of the cyst content, biopsy and vaporization of the internal wall with a CO2 fiber laser. Patients underwent pelvic ultrasound examination to determine the AFC and blood sampling to determine AMH levels before surgery and at 1- and 3-month follow-up. PARTICIPANTS/MATERIALS, SETTING, METHODS:Patients undergoing surgery for symptomatic endometriomas (infertility and/or pelvic pain) larger than 3 cm were randomized in two groups according to the surgical technique. Patients aged ?40 years, or with deep infiltrating endometriosis/adenomyosis, or previously submitted to surgical procedures on the ovaries or to hysterectomy were excluded from the study. The primary endpoint was the comparison of intra-group AFC changes before and after surgery (?AFC) between the two groups (?AFC Group 1 versus ?AFC Group 2). The secondary endpoint was the modification of serum AMH before and after surgery (?AMH) between the two groups (?AMH Group 1 versus ?AMH Group 2). MAIN RESULTS AND THE ROLE OF CHANCE:The AFC of the operated ovary was significantly increased in Group 2 (laser vaporization) compared with Group 1 (cystectomy) after surgery (Group 1: from 4.1 ± 2.2 [mean ± SD] at baseline to 6.3 ± 3.5 at 3-month follow-up; 95% CI: 0.9-4; Group 2: from 3.6 ± 1.9 at baseline to 8.6 ± 4.2 at 3-month follow-up; 95% CI: 2.8-7.1; P = 0.016); serum AMH levels were significantly reduced at 3 months in Group 1 (from 2.6 ± 1.4 ng/mL at baseline to 1.8 ± 0.8 ng/mL at 3-month follow-up; 95% CI: -1.3 to -0.2; P = 0.012) compared with no reduction in Group 2 (from 2.3 ± 1.1 ng/mL at baseline to 1.9 ± 0.9 ng/mL at 3-month follow-up; 95% CI: -1 to -0.2; P = 0.09). LIMITATIONS, REASON FOR CAUTION:The key limitations of the trial were the low accuracy of AFC in estimating the ovarian reserve in ovaries with endometriomas, the limited study size and the relatively short follow-up, which do not allow us to draw definitive conclusions. WIDER IMPLICATIONS OF THE FINDINGS:The present study suggests that CO2 technology may treat endometrioma with minimal damage to the adjacent healthy ovarian tissue; however, this study should be considered as a preliminary clinical trial, intended to stimulate future larger trials to address this clinically relevant issue. STUDY FUNDING/COMPETING INTEREST(S):None. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov NCT03227640. TRIAL REGISTRATION DATE:9 July 2017. DATE OF FIRST PATIENT’S ENROLLMENT:24 July 2017.

Project description:Open radical cystectomy (ORC) and urinary diversion in patients with bladder cancer (BCa) are associated with significant perioperative complication risk.To compare perioperative complications between robot-assisted radical cystectomy (RARC) and ORC techniques.A prospective randomized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy (RC), pelvic lymph node dissection (PLND), and urinary diversion. Patients were randomized to ORC/PLND or RARC/PLND, both with open urinary diversion. Patients were followed for 90 d postoperatively.Standard ORC or RARC with PLND; all urinary diversions were performed via an open approach.Primary outcomes were overall 90-d grade 2-5 complications defined by a modified Clavien system. Secondary outcomes included comparison of high-grade complications, estimated blood loss, operative time, pathologic outcomes, 3- and 6-mo patient-reported quality-of-life (QOL) outcomes, and total operative room and inpatient costs. Differences in binary outcomes were assessed with the chi-square test, with differences in continuous outcomes assessed by analysis of covariance with randomization group as covariate and, for QOL end points, baseline score.The trial enrolled 124 patients, of whom 118 were randomized and underwent RC/PLND. Sixty were randomized to RARC and 58 to ORC. At 90 d, grade 2-5 complications were observed in 62% and 66% of RARC and ORC patients, respectively (95% confidence interval for difference, -21% to -13%; p=0.7). The similar rates of grade 2-5 complications at our mandated interim analysis met futility criteria; thus, early closure of the trial occurred. The RARC group had lower mean intraoperative blood loss (p=0.027) but significantly longer operative time than the ORC group (p<0.001). Pathologic variables including positive surgical margins and lymph node yields were similar. Mean hospital stay was 8 d in both arms (standard deviation, 3 and 5 d, respectively; p=0.5). Three- and 6-mo QOL outcomes were similar between arms. Cost analysis demonstrated an advantage to ORC compared with RARC. A limitation is the setting at a single high-volume, referral center; our findings may not be generalizable to all settings.This trial failed to identify a large advantage for robot-assisted techniques over standard open surgery for patients undergoing RC/PLND and urinary diversion. Similar 90-d complication rates, hospital stay, pathologic outcomes, and 3- and 6-mo QOL outcomes were observed regardless of surgical technique.Of 118 patients with bladder cancer who underwent radical cystectomy, pelvic lymph node dissection, and urinary diversion, half were randomized to open surgery and half to robot-assisted laparoscopic surgery. We compared the rate of complications within 90 d after surgery for the open group versus the robotic group and found no significant difference between the two groups.ClinicalTrials.gov identifier NCT01076387, www.clinicaltrials.gov.

Dataset Information

Epinephrine minimizes the use of bipolar coagulation and preserves ovarian reserve in laparoscopic ovarian cystectomy: a randomized controlled trial.

Publications

Epinephrine minimizes the use of bipolar coagulation and preserves ovarian reserve in laparoscopic ovarian cystectomy: a randomized controlled trial.

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