Back to resultsEarly Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones
Primary Purpose
Choledocholithiasis With Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Choledocholithiasis With Cholecystitis focused on measuring Choledocholithiasis, Early, Delayed, Laparoscopic cholecystectomy, ERCP, Nassar scale
Eligibility Criteria
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.
Sites / Locations
- Kafrelsheikh University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Early group
Delayed group
Arm Description
Outcomes
Primary Outcome Measures
operative time
the time to perform laparoscopic cholecystectomy from the time of incision to the last suture
Secondary Outcome Measures
intraoperative difficulty and complications
the difficulties that face the surgeon during the surgery and the early complications that result
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04475796
Brief Title
Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones
Official Title
Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis With Cholecystitis
Keywords
Choledocholithiasis, Early, Delayed, Laparoscopic cholecystectomy, ERCP, Nassar scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early group
Arm Type
Active Comparator
Arm Title
Delayed group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Laparoscopic cholecystectomy performed after ERCP
Primary Outcome Measure Information:
Title
operative time
Description
the time to perform laparoscopic cholecystectomy from the time of incision to the last suture
Time Frame
one day
Secondary Outcome Measure Information:
Title
intraoperative difficulty and complications
Description
the difficulties that face the surgeon during the surgery and the early complications that result
Time Frame
one day
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
adult
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Aouf, Dr.
Organizational Affiliation
Kafrelsheikh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kafrelsheikh University
City
Kafr Ash Shaykh
State/Province
Kafr Al Sheikh
ZIP/Postal Code
33516
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones
We'll reach out to this number within 24 hrs