Feasibility of non-routine abdominal drainage for minimally invasive liver surgery: study protocol for a multicenter randomized controlled clinical trial

Abstract

Introduction: Minimally invasive liver surgery (MILS), such as laparoscopic and robotic hepatectomy, has been developed and is an effective alternative to traditional open hepatectomy. Although surgical techniques and postoperative management have improved, many institutions continue to perform routine postoperative abdominal drainage. In open hepatectomy, abdominal drainage after uncomplicated hepatectomy increases overall and wound-related complications without a reduction in the risk of intra-abdominal fluid collections that require intervention. The aim of this study was to elucidate the feasibility of non-routine abdominal drainage for patients who undergo MILS for tumors located outside the posterosuperior area. Methods and analysis: This study is a multicenter randomized controlled trial and will recruit 182 patients who undergo MILS. The study duration is three years, including a 2-year registration duration. Participants will be randomly assigned to either the non-routine drainage group or the routine drainage group (ratio 1:1) to prove non-inferiority. The primary study outcome is the incidence of in-hospital postoperative complications of Clavien-Dindo grade ≥ II. The secondary study outcomes are length of postoperative hospital stay, incidences of specific postoperative complications and all postoperative complications, and surgery-related mortality. Ethics and dissemination: Ethical approval has been obtained from the institutional review board (No. 20232008). The results of this study will be published in international peer-reviewed journals.