Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599437
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Index Laparoscopic Cholecystectomy Following Clearance of Common Bile Duct Stones Via Endoscopic Retrograde Cholangiography
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if early laparoscopic cholecystectomy is safe and feasible when performed during the same admission for patients with concomitant gallbladder and common bile duct stones after clearance of CBD stones via ERCP in comparison to Late laparoscopic cholecystectomy 6 weeks after ERCP The main questions it aims to answer are laparoscopic cholecystectomy
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
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
Detailed Description:
The study population of this randomized controlled trial study is those who underwent CBD stone clearance by ERCP The included fifty patients were stratified randomly into two groups early and delayed
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None