An interventional study of laparoscopic cholecystectomy and Late laparoscopic cholecystectomy in Choledocholithiasis with Cholecystitis, sponsored by Damanhour Medical National Institute. Completed at 1 site in Egypt. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Damanhour Medical National Institute · Not applicable, Interventional, and Treatment
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
Participants will:
Come to the outpatient clinic every week after intervention for follow-up for 3 months after surgery.
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.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →This is the only study on the registry with Damanhour Medical National Institute as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: patients with any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Early laparoscopic cholecystectomy is performed on next day within 24 hours after common bile duct stone removal by ERCP.
Procedure: laparoscopic cholecystectomy
Late laparoscopic cholecystectomy is performed 6 weeks after common bile duct stones clearance
Procedure: Late laparoscopic cholecystectomy
Early laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP.
Laparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct.
recurrence of biliary events
the occurence of acute cholecystitism biliary colics, common bile duct stonem pancreatitisand cholangitis after ERCP while waiting for laparoscopic cholecystectomy
Time frame: up to 3 months after surgery
operative time
time from the first incision of skin to skin closure and completion of surgery
Time frame: during surgery
pancreatitis
acute inflammation of the pancreas : abdominal pain, elevated lipase and amylase ( more than 3 folds) and/or findings specific for the pancreatitits on imaging.
Time frame: 3 months after surgery
conversion to open surgery
termination of the laparoscopic procedure and perfome the surgery by the conventional open surgery
Time frame: During surgery
Bleeding
Intraoperative or postoperative bleeding that requires blood transfusion
Time frame: during surger and up to 3 weeks
the presence of intraoperative adhesions
Adhesions around the gallbladder and at the Calot\'s triangle
Time frame: During surgery
Bile leak
the leak of bile through the drain or intraabdominally
Time frame: up to 1 week after surgery
Wound infection
Any evidence of infection in the wounds : redness, pain or discharge of infected fluids from the wounds
Time frame: up to 3 months after surgery
hospital stays
the sum the length of stay after ERCP and laparoscopic cholecystectomy including readmission for complication management
Time frame: from admission to the end of post operative follow up at 3 months after surgery
post oprative pain
the degree pain described by the patients after surgery on the visual rating scale
Time frame: after surgery and up to 3 days
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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