Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

Not Applicable

Completed

• Conditions: Acute Cholecystitis

• Registration Number: NCT07101315
• Lead Sponsor: Sana'a University

Brief Summary

The goal of this clinical trial is to learn if performing gallbladder surgery early is as safe and effective as delaying it for people with acute cholecystitis (a sudden gallbladder infection). The main questions it aims to answer are:

* Do participants who have early surgery have a similar rate of complications compared to those who have delayed surgery?

* How does the timing of surgery affect the length of the hospital stay?

Researchers will compare two groups:

1. An early surgery group

2. A delayed surgery group

Participants in the early surgery group had their gallbladder removed within 72 hours of when their symptoms started. Participants in the delayed surgery group were first treated with medications and had their surgery 6-8 weeks later.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2025-07
• Study First Submitted: 2025-07-27
• Study First Submitted QC: 2025-07-27
• Last Update Submitted: 2025-07-27
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Yemeni nationals aged 18-70 years
• A clinical diagnosis of acute cholecystitis confirmed by clinical presentation, laboratory findings, and imaging studies
• Symptom duration of less than 72 hours at presentation
• Fitness for general anesthesia (American Society of Anesthesiologists [ASA] physical status classification I-III)
• Provision of written informed consent

Exclusion Criteria

• Evidence of choledocholithiasis or acute cholangitis
• Severe comorbidities precluding surgery (ASA class IV-V)
• Coagulopathy (INR >1.5 or platelet count <100,000/μL)
• Pregnancy
• Previous major upper abdominal surgery
• Patient refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Postoperative Complications	Within 30 days post-surgery	Incidence of any postoperative complication within 30 days
Conversion to Open Surgery	Intraoperative	Rate of conversion from laparoscopic to open cholecystectomy during the procedure.
Operative Time	Intraoperative	Duration of surgery, measured in minutes from skin incision to skin closure.

Secondary Outcome Measures

Name	Time	Method
Postoperative Length of Hospital Stay	Up to 30 days post-surgery	Number of days from surgery to hospital discharge.
Duration of Postoperative Pain	Up to 30 days post-surgery	Number of days from surgery until the participant was free of the need for analgesic medication.
Time to Return to Normal Daily Activities	Up to 30 days post-surgery	Number of days from surgery until the participant reported a full return to normal daily activities.
30-Day Readmission Rate	30 days	Rate of unplanned hospital readmission for any cause within 30 days of discharge.

Trial Locations

Locations (2)

Al-Kuwait University Hospital; 🇾🇪 Sanaa, Yemen

Al-Thawra Modern General Hospital; 🇾🇪 Sanaa, Yemen