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

NCT07345663 | Completed

• 2 other identifiers: LW-202601F-KY-0022-20220325-01
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Choledochotomy Closure Time

  The time taken to complete choledochotomy closure, from the beginning of suturing to the completion of the final knot. This measure is recorded in minutes for each patient.

  Closure time is measured intraoperatively during the procedure and recorded once closure is complete.

Secondary Outcomes (1)

• Total Operative Time

  The total operative time is measured during the procedure, from the first incision to the final closure.

Other Outcomes (1)

• Intraoperative Blood Loss

  Blood loss is recorded intraoperatively at the end of the surgery, based on visual estimation and suction collection.

Study Arms (2)

Modified Continuous Suturing

Procedure: Modified continuous suture

Interrupted Suturing

Procedure: Interrupted suture

Interventions

Interrupted suture PROCEDURE

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.

Interrupted Suturing

Modified continuous suture PROCEDURE

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.

Modified Continuous Suturing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients who underwent laparoscopic common bile duct exploration (LCBDE) with T-tube drainage at our institution between January 2020 and November 2024. Inclusion criteria include patients who had choledochotomy closure performed with either modified continuous suturing (MCS) or interrupted suturing (IS). Patients were retrospectively reviewed, and baseline characteristics such as age, gender, stone burden, and ASA classification were collected. Exclusion criteria include patients with incomplete data or those who underwent procedures other than LCBDE.

You may qualify if:

• (1) age ≥18 years; (2) imaging-confirmed CBDS; (3) intraoperative placement of a T-tube; and (4) Common bile duct (CBD) diameter ≥6 mm

You may not qualify if:

• coagulopathy, severe cognitive impairment, multiple intrahepatic stones, biliary stricture, malignancy, liver cirrhosis, severe acute pancreatitis (BISAP score ≥3), and acute cholangitis complicated by septic shock, classified as Grade III according to the Tokyo Guidelines 2018

Sponsors & Collaborators

• Yantai Affiliated Hospital of Binzhou Medical University: lead

Study Sites (1)

Yantai affiliated hospital of Binzhou Medical University

Yantai, Shandong, 264100, China

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 16, 2026
• Study Start: January 1, 2020
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

CN (1)