Modified Continuous Versus Interrupted Choledochotomy Closure in LCBDE With T-Tube Drainage: A Propensity Score-Matched Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Choledochotomy Closure Time
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1) age ≥18 years; (2) imaging-confirmed CBDS; (3) intraoperative placement of a T-tube; and (4) Common bile duct (CBD) diameter ≥6 mm
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Choledochotomy Closure Time
Time Frame: Closure time is measured intraoperatively during the procedure and recorded once closure is complete.
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.
Secondary Outcomes
- Total Operative Time(The total operative time is measured during the procedure, from the first incision to the final closure.)
Investigators
Piyou Ji
associate chief physician
Yantai Affiliated Hospital of Binzhou Medical University