Efficacy and safety evaluation of a reusable advanced hemostatic device (Vi-Sealer) during total laparoscopic hysterectomy in South Korea (KGOG4009/Vi-TLH trial): study protocol for a multicenter, open-label, non-inferiority randomized controlled trial

Abstract

BackgroundAdvanced hemostatic devices (AHDs) are widely utilized in gynecologic minimally invasive surgeries. These AHDs control ultrasonic or bipolar electric/thermal energy with a feedback mechanism and effectively seal vessels without thermal spread. However, most AHDs are single-use, potentially increasing surgical costs. Vi-Sealer, a reusable AHD with an interchangeable blade, aims to address this issue. This study assesses operative outcomes and complications to evaluate the efficacy and safety of Vi-Sealer compared to other AHDs.MethodsThis multicenter, open-label, non-inferiority, randomized controlled trial compares Vi-Sealer with other AHDs in 280 patients undergoing total laparoscopic hysterectomy (TLH) for benign gynecologic diseases, assuming a 25-min (20%) non-inferiority margin in operative time. Cases with uterine or preinvasive cervical pathology were included, while those with huge tumor size were excluded. Participants are stratified into two cohorts based on competing devices. Each cohort consists of 140 participants, randomized in a 1:1 ratio to undergo TLH with either Vi-Sealer or a comparator device-LigaSure in cohort 1 and other AHDs in cohort 2. This study will be conducted at university-affiliated hospitals in South Korea, where recruitment will be carried out within the gynecology clinics. The enrollment is planned to begin in November 2022. Participants will be blinded, whereas surgeons will not be due to the nature of surgery. The primary endpoint is operation time (min) defined as the duration of the initial skin incision to the completion of skin closure, while secondary endpoints include blood loss (mL), medical cost (won), operating surgeons' device function scores, and adverse events. Outcomes will be analyzed separately for each cohort. Adverse events and complications will be assessed clinically until postoperative follow-up, per CTCAE. This trial is currently in the recruitment phase with active enrollment ongoing.DiscussionThis study will evaluate the efficacy, safety, and cost analysis of the reusable Vi-Sealer in TLH. Through the comparison of AHDs, this is expected to provide robust evidence to determine whether the Vi-Sealer is non-inferior to disposable AHDs.Trial registrationThis study was registered on ClinicalTrials.gov (NCT05629611) on November 29, 2022 (https://clinicaltrials.gov/study/NCT05629611?intr=vi-sealer&rank=1) and cris.nih.go.kr (KCT0008008) on December 13, 2022 (https://cris.nih.go.kr/cris/search/detailSearch.do?seq=23737&search_page=L). This is currently open for enrollment.