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Clinical Trials/NCT06514911
NCT06514911RecruitingNot Applicable

Primary Closure Versus T-tube Drainage Following Laparoscopic Cholodochotomy in Management of CBD Stones

Sohag University1 site in 1 country50 target enrollmentStarted: June 10, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
1
Primary Endpoint
biliary leakage in the management of CBD stones

Study Overview

Brief Summary

The aim of this study is to compare the outcomes of primary closure of cholodochotomy incision versus T-tube drainage in laparoscopic common bile duct exploration for management of CBD stones and provide evidence-based guidance to the selection of the most appropriate operative technique.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •patients with a definitive preoperative diagnosed with CBD stones.
  • •a CBD diameter of ≥1 cm.
  • •patients are fit for surgery

Exclusion Criteria

  • •patients with liver cirrhosis.
  • •a CBD diameter of <1 cm
  • •malignancy in the biliary tract or CBD stricture .
  • •patients are not fit for surgery.

Arms & Interventions

primary closure following Laparoscopic cholodochotomy in management of CBD stones

Active Comparator

Intervention: primary closure following Laparoscopic cholodochotomy in management of CBD stones (Procedure)

T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones

Active Comparator

Intervention: T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones (Procedure)

Outcomes

Primary Outcomes

biliary leakage in the management of CBD stones

Time Frame: 3 days after the operation

peritoneal collection of bile after common bile duct exploration

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Islam Khalaf Mohamed

Resident, Department of General Surgery, Faculty of Medicine, Sohag University

Sohag University

Study Sites (1)

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