Optimal Timings of Laparoscopic Cholecystectomy After ERCP in Patients With Gallstones Along With CBD Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-70
SponsorRija Zainab
About this trial
This randomized controlled trial aims to compare the mean operative time and outcomes of early versus delayed laparoscopic cholecystectomy after ERCP in patients with cholelithiasis and choledocholithiasis. Patients will be randomized into two groups: early cholecystectomy (within 72 hours of ERCP) and delayed cholecystectomy (≥1 month after ERCP). Outcomes include operative time, intra-operative blood loss, hospital stay, and conversion to open cholecystectomy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with cholelithiasis with choledocholithiasis based on clinical and radiological findings (right subcostal pain, presence of gallstones, and dilated common bile duct on ultrasound and MRCP)
Age 14 to 70 years
Both males and females
Duration of symptoms less than 3 days
Disqualifiers
Features suggestive of malignancy on imaging
Patients who develop severe pancreatitis after ERCP
Trial design
Design model
Parallel
Treatments tested in this trial
Early laparoscopic cholecystectomy
Procedure/SurgeryLaparoscopic removal of gall bladder within 72hours of laparoscopic cholecystectomy
Delayed Laparoscopic cholecystectomy
Procedure/SurgeryLaparoscopic removal of gall bladder 2 weeks or more after successful ERCP
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Early laparoscopic cholecystectomyExperimental treatment 1 intervention
Group B: Delayed Laparoscopic cholecystectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean Operative time
Duration of surgery measured from the first incision to closure of the last incision.
Time frame
During surgerySecondary outcomes
1
Length of Hospital Stay
Total number of days from hospital admission to discharge.
Time frame
From admission to discharge (up to 30 days)2
Intraoperative Blood Loss
Blood loss measured in milliliters from suction apparatus during surgery.
Time frame
During Surgery3
Conversion to Open Cholecystectomy
Number of patients requiring conversion from laparoscopic to open surgery
Time frame
During SurgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Rija Zainab
Lead sponsor
Shaikh Zayed Hospital, Lahore
Sponsor institution
Shaikh Zayed Hospital, Lahore
Collaborator
Source ClinicalTrials.gov