- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06197373
Laparoscopic Cholecystectomy After ERCP
April 4, 2024 updated by: Mohamed Bakr Mohamed Ahmed
Outcomes of Early and Late Laparoscopic Cholecystectomy (LC) After Endoscopic Retrograde CholangioPancreatography (ERCP), Prospective Study .
Evaluation of outcomes of early and late laparoscopic cholecystectomy after ERCP
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Evaluation of both benefits and harms of doing laparoscopic cholecystectomy early within first 72 hours and late from the third day up to 2 months after ERCP
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mahran
- Phone Number: 01062837490
- Email: mbakrmahran00@gmail.com
Study Contact Backup
- Name: Bakr
- Phone Number: 01092868621
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Female patient present with CBD obstruction and GB stones So Undergoing ERCP then Laparoscopic cholecystectomy
Description
Inclusion Criteria:
- female patient
- 18-60 years old
Exclusion Criteria:
- male patient
- extremes of age less than 18 and more than 60
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Early laparoscopic cholecystectomy after ERCP
Evaluation of outcomes of early ( within 72 hours) laparoscopic cholecystectomy after ERCP
|
Doing laparoscopic cholecystectomy after ERCP at different intervals
Other Names:
|
Late laparoscopic cholecystectomy after ERCP
Evaluation of outcomes of late ( form third day up to 2months ) laparoscopic cholecystectomy after ERCP
|
Doing laparoscopic cholecystectomy after ERCP at different intervals
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of the operation
Time Frame: 5 hours
|
Measuring the time of the operation
|
5 hours
|
Bleeding during operation
Time Frame: 5 hours
|
Measuring amount of blood loss during operation
|
5 hours
|
Hospital stay duration
Time Frame: 7 days
|
Measuring time of hospital stay
|
7 days
|
Rate of Conversion to open cholecystectomy
Time Frame: 5 hours
|
Documenting number of cases undergoing conversion from laparoscopic to open cholecystectomy
|
5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total cost of the medical service in both categories
Time Frame: 2 months
|
Measuring the cost of the medical service in both categories for economic preference
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Thabet, Assiut University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2024
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
December 9, 2023
First Submitted That Met QC Criteria
January 6, 2024
First Posted (Actual)
January 9, 2024
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 4, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- cholecystectomy after ERCP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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