Choledochotomy Techniques During LCBDE

NCT ID: NCT04463381

Last Updated: 2020-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-01

Study Completion Date

2020-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Choledocholithiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

sharp choledochotomy by a scalpel or scissor

choledochotomy techniques during LCBDE

Intervention Type PROCEDURE

Group 2

choledochotomy by a diathermy hook

choledochotomy techniques during LCBDE

Intervention Type PROCEDURE

Group 3

choledochotomy by an ultrasonic device

choledochotomy techniques during LCBDE

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

choledochotomy techniques during LCBDE

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emad Ali Ahmed Ali

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emad Ali Ahmed, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag University

Sohag, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22/05/2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.