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:

Background

Advanced 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.

Methods

This 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%) n

SUBMITTER: Kim M 

PROVIDER: S-EPMC12595730 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature