- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04475796
Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones
July 14, 2020 updated by: Ahmed Aouf, Kafrelsheikh University
The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy (LC) is a commonly performed treatment modality for concomitant common bile duct stones (CBDs) and gallbladder stones.
There has been a debate about the appropriate timing of laparoscopic cholecystectomy after ERCP.
The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones adding new parameters like Nassar scale.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kafr Al Sheikh
-
Kafr Ash Shaykh, Kafr Al Sheikh, Egypt, 33516
- Kafrelsheikh University
-
-
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
16 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients who underwent laparoscopic cholecystectomy after clearance of CBDs by ERCP
Exclusion Criteria:
- advanced liver cirrhosis, pancreatitis, acute cholangitis, suspected malignancy, severe malnutrition, and pregnancy.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Early group
|
Laparoscopic cholecystectomy performed after ERCP
|
Active Comparator: Delayed group
|
Laparoscopic cholecystectomy performed after ERCP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
operative time
Time Frame: one day
|
the time to perform laparoscopic cholecystectomy from the time of incision to the last suture
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intraoperative difficulty and complications
Time Frame: one day
|
the difficulties that face the surgeon during the surgery and the early complications that result
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed Aouf, Dr., Kafrelsheikh 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 (Actual)
February 1, 2019
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
July 14, 2020
First Submitted That Met QC Criteria
July 14, 2020
First Posted (Actual)
July 17, 2020
Study Record Updates
Last Update Posted (Actual)
July 17, 2020
Last Update Submitted That Met QC Criteria
July 14, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 124569124569
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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