Primary Barbed Suture Versus T-Tube Drainage After Laparoscopic Common Bile Duct Exploration: A Randomized Controlled Trial

腹腔镜胆总管探查术后采用带倒刺缝线进行原位缝合与T管引流的随机对照试验

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Abstract

BACKGROUND AND AIMS: T-tube drainage has traditionally been used after laparoscopic common bile duct exploration (LCBDE) to reduce the risk of bile leakage; however, it is associated with prolonged hospital stay and tube-related complications. Primary closure of the common bile duct has emerged as an alternative strategy, but concerns regarding postoperative safety and patient selection criteria remain. This study aimed to compare perioperative outcomes between primary barbed suture closure and T-tube drainage following LCBDE. METHODS: This prospective single-center randomized controlled trial enrolled patients with common bile duct stones undergoing LCBDE. Eligible patients were randomly assigned in a 1:1 ratio to either primary closure using a continuous barbed suture or conventional T-tube drainage. Primary outcomes included operative time, postoperative drainage volume, length of hospital stay, and hospitalization costs. Secondary outcomes included postoperative complications. Statistical analyses were performed using appropriate independent-sample tests and multivariable regression models, with effect sizes and 95% confidence intervals reported. Exploratory analyses assessed associations between common bile duct diameter and clinical outcomes. RESULTS: A total of 45 patients were included in the final analysis (primary closure, n = 22; T-tube drainage, n = 23). Baseline characteristics were comparable between groups. Compared with T-tube drainage, primary closure was associated with shorter operative time, reduced postoperative drainage volume, shorter hospital stay, and lower hospitalization costs. No bile leakage or biliary stricture was observed in either group during the follow-up period. Exploratory analyses suggested associations between common bile duct diameter and selected perioperative outcomes. CONCLUSION: Primary barbed suture closure after LCBDE was associated with favorable perioperative outcomes compared with T-tube drainage, without an observed increase in early postoperative complications. Given the limited sample size, larger multicenter randomized controlled trials with extended follow-up are needed to confirm long-term safety.

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