Choledochotomy Techniques During LCBDE

NCT04463381 | Completed DMC

• 1 other identifier: 22/05/2020
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with choledocholithiasis during the early and late postoperative periods.

Conditions

Choledocholithiasis

Keywords

choledochotomy technique; CBD stones; choledocholithiasis

Outcome Measures

Primary Outcomes (2)

• biliary leakage/fistula

  According to the international study group of liver surgery, bile leakage is defined as fluid with an elevated bilirubin level (3 times higher than the serum bilirubin measured at the same time) in the abdominal drain or the intra-abdominal fluid on or after POD 3, or as the need for radiologic intervention because of biliary collections or re-laparotomy resulting from biliary peritonitis

  first postoperative 6 months up to 6 years postoperatively

• biliary stricture

  The biliary stricture is known as abnormal narrowing of the bile duct associated with the rising of cholestasis indexes. Additionally, it has required an invasive treatment such as ERCP, percutaneous transhepatic drainage, or re-surgery \[16\]. Biliary complications were diagnosed by trans-tubal cholangiography or through MRCP and could be managed conservatively, ERCP, if there is an accessible route, PTD or surgical intervention.

  2-6 years

Secondary Outcomes (9)

• operative time

  from incision to closure

• intraoperative bleeding

  during surgery

• conversion rate

  during surgery

• jaundice

  2-6 years

• wound sepsis

  2-6 years

Study Arms (3)

Group 1

sharp choledochotomy by a scalpel or scissor

Procedure: choledochotomy techniques during LCBDE

Group 2

choledochotomy by a diathermy hook

Procedure: choledochotomy techniques during LCBDE

Group 3

choledochotomy by an ultrasonic device

Procedure: choledochotomy techniques during LCBDE

Interventions

choledochotomy techniques during LCBDE PROCEDURE

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

During the study period, 85 patients (52 females and 33 males) were enrolled in this study which they were complaining of manifestations of CBD stones and treated using laparoscopic approaches, using various choledochotomy techniques.

You may qualify if:

• All adult patients with choledocholithiasis who underwent LCBDE combined with LC were enrolled in this study. No limitations as regards the stone sizes or numbers were considered. The CBD diameter should be at least ± 1 cm.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Study Officials

• Emad Ali Ahmed, MD, PhD

  Sohag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 9, 2020
• Study Start: March 1, 2014
• Primary Completion: February 28, 2018
• Study Completion: March 1, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

EG (1)