Clinical trial NCT04463381: Choledochotomy Techniques During LCBDE
Official title: Impact of Choledochotomy Techniques During Laparoscopic CBD Exploration on Short- and Long-term Clinical Outcomes: Time to Change Concepts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choledocholithiasis
Keywords: choledochotomy technique
CBD stones
choledocholithiasis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 85
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: Background: 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.

Methods: from March 2014 to February 2018, 85 patients with choledocholithiasis (52 females and 33 males) were enrolled in this study. These patients were treated by LCBDE using various choledochotomy techniques, including scalpel or scissor (28 patients, 33%) in group I, using diathermy hook (35 patients, 41%) in group II, or using an ultrasonic device (22 patients, 26 %) in group III. Postoperative follow-up was done for assessment of all possible complications either early (within 3-6 months postoperatively), or late (2-6 years postoperatively) with meticulous observation and study of any relevant postoperative event.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Exclusion criteria were normal caliber or stenosed CBD, or the presence of overt cholangitis. Additionally, treated patients with the trans-cystic approach for stone extraction were excluded from this study.

Primary outcomes:
measure: biliary leakage/fistula
timeFrame: first postoperative 6 months up to 6 years postoperatively
measure: biliary stricture
timeFrame: 2-6 years
Secondary outcomes:
measure: operative time
timeFrame: from incision to closure
measure: intraoperative bleeding
timeFrame: during surgery
measure: conversion rate
timeFrame: during surgery
measure: jaundice
timeFrame: 2-6 years
measure: wound sepsis
timeFrame: 2-6 years
measure: cholangitis
timeFrame: 2-6 years
measure: wound dehiscence
timeFrame: 2-6 years
measure: Peritoneal sepsis and abscess
timeFrame: first postoperative 6 months
measure: Recurrent stones
timeFrame: 2-6 years
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag University
name: Emad Ali Ahmed, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: