For Patients with Stones in Gallbladder and Bile Duct Stones At the Same Time, Surgical Removal of the Gallbladder with the Laparoscope is Done in the Same Admission Compared to Its Removal After 6 Weeks Following Successful Removel of the Stones from the Bile Ducts by the Side View Endoscope
NCT ID: NCT06599437
Last Updated: 2024-09-19
Study Results
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.
COMPLETED
NA
50 participants
INTERVENTIONAL
2021-12-01
2024-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Does index laparoscopic cholecystectomy associate with less recurrence of biliary complications?
* Is index laparoscopic cholecystectomy feasible and safe for the patients in terms of intraoperative difficulties, conversion to open, hospital stay, and postoperative complications than late laparoscopic cholecystectomy? the investigator will compare index laparoscopic cholecystectomy with late laparoscopic cholecystectomy 6 weeks after ERCP to see if index laparoscopic cholecystectomy is safe and feasible and associated with better outcomes.
Participants will:
Come to the outpatient clinic every week after intervention for follow-up for 3 months after surgery.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy
NCT05901363
Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones
NCT04475796
Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones
NCT01189734
"Endoscopy First" or "Laparoscopic Cholecystectomy First" for Patients With Intermediate Risk of Choledocholithiasis
NCT03658863
Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days?
NCT03999645
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Randomization was done using computer-generated random number sequences in concealed envelopes with a block randomization design. Laparoscopic cholecystectomy is performed on the next day after successful clearance of stones from CBD while, the patient is still admitted, for the early group and postponed 4 to 6 weeks for the delayed group after the patient is discharged home.
Laparoscopic cholecystectomy was performed by the same surgical team for both groups.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Early same admission laparoscopic cholecystectomy ( group A)
Early laparoscopic cholecystectomy is performed on next day within 24 hours after common bile duct stone removal by ERCP.
laparoscopic cholecystectomy
Early laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP.
Late laparoscopic cholecystectomy ( group B)
Late laparoscopic cholecystectomy is performed 6 weeks after common bile duct stones clearance
Late laparoscopic cholecystectomy
Laparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
laparoscopic cholecystectomy
Early laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP.
Late laparoscopic cholecystectomy
Laparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Suspicion of post-ERCP bleeding or perforation,
* Associated malignancy
* Those in whom ERCP failed to clear the CBD stones
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Damanhour Medical National Institute
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wael Ahmed El-Dawy
Lecturer of Hepatopacreatobiliary and GI Surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Damanhur Medical National Institute
Damanhur, Behira, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HD000192
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.