NCT07345663

Modified Continuous Versus Interrupted Choledochotomy Closure in LCBDE With T-Tube Drainage

Modified Continuous Versus Interrupted Choledochotomy Closure in LCBDE With T-Tube Drainage: A Propensity Score-Matched Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 360 (actual)
• Sponsor: Yantai Affiliated Hospital of Binzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational study aims to compare two techniques for closing the common bile duct incision (choledochotomy) after laparoscopic common bile duct exploration (LCBDE) with T-tube drainage. Interrupted suturing is commonly used, but it can be time-consuming during laparoscopic surgery. A modified continuous suturing approach may improve efficiency while maintaining safety. We will retrospectively review patients who underwent LCBDE with T-tube drainage at our institution. Patients will be grouped according to the choledochotomy closure technique used during routine clinical care (modified continuous suturing versus conventional interrupted closure). To reduce baseline differences between groups, propensity score matching based on preoperative and intraoperative characteristics will be applied. The primary outcome is choledochotomy closure time. Secondary outcomes include total operative time and perioperative safety outcomes, such as bile leakage and other postoperative complications, as well as short-term postoperative recovery indicators. This study will provide comparative evidence on operative efficiency and safety of continuous versus interrupted choledochotomy closure in the setting of LCBDE with T-tube drainage.

Conditions

• Common Bile Duct Calculi

Interventions

Type	Name	Description
PROCEDURE	Modified continuous suture	Modified continuous suture was performed using 4-0 knotless barbed polydioxanone sutures (Quill™, Surgical Specialties Corporation). A continuous full-thickness suture was placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm. After completion of the continuous closure, 1-2 reinforcing stitches were placed in the opposite direction (from proximal to distal), and the suture was secured by tying to the tail end of the initial stitch.
PROCEDURE	Interrupted suture	Interrupted suture was performed using 4-0 antibacterial monofilament polydioxanone sutures (PDS™ Plus, Ethicon, LLC). Interrupted sutures were placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm; each stitch was tied separately. An additional 1-2 reinforcing stitches (transverse or figure-of-eight) were placed around the T-tube exit site to enhance apposition between the choledochotomy edge and the tube wall.

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-11-30
• Completion: 2025-12-31
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: China