Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

NCT07101315 | Completed

• 1 other identifier: SanaaU-Chole-001
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

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:
• An early surgery group
• A delayed surgery group

Conditions

Acute Cholecystitis

Keywords

Laparoscopic Cholecystectomy; Gallstones; Biliary Disease; Surgical Timing

Outcome Measures

Primary Outcomes (3)

• Overall Postoperative Complications

  Incidence of any postoperative complication within 30 days

  Within 30 days post-surgery

• Conversion to Open Surgery

  Rate of conversion from laparoscopic to open cholecystectomy during the procedure.

  Intraoperative

• Operative Time

  Duration of surgery, measured in minutes from skin incision to skin closure.

  Intraoperative

Secondary Outcomes (4)

• Postoperative Length of Hospital Stay

  Up to 30 days post-surgery

• Duration of Postoperative Pain

  Up to 30 days post-surgery

• Time to Return to Normal Daily Activities

  Up to 30 days post-surgery

• 30-Day Readmission Rate

  30 days

Study Arms (2)

Early Laparoscopic Cholecystectomy (ELC)

EXPERIMENTAL

Participants underwent laparoscopic cholecystectomy within 72 hours of symptom onset during the index hospital admission.

Procedure: Laparoscopic Cholecystectomy

Delayed Laparoscopic Cholecystectomy (DLC)

ACTIVE COMPARATOR

Participants received initial non-operative management with antibiotics and analgesics, followed by elective laparoscopic cholecystectomy 6-8 weeks later.

Procedure: Laparoscopic Cholecystectomy

Interventions

Laparoscopic Cholecystectomy PROCEDURE

Standard four-port laparoscopic cholecystectomy was performed by a specialist or resident surgeon.

Delayed Laparoscopic Cholecystectomy (DLC); Early Laparoscopic Cholecystectomy (ELC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sana'a University: lead
• Al-Thawra Modern General Hospital: collaborator
• Al-Kuwait University Hospital: collaborator

Study Sites (2)

Al-Kuwait University Hospital

Sanaa, Yemen

Location

Al-Thawra Modern General Hospital

Sanaa, Yemen

Location

MeSH Terms

Conditions

Cholecystitis, Acute; Gallstones; Gallbladder Diseases

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Cholecystitis; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Mohammed A Issa, Professor

  Sana'a University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: January 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available beginning 3 months after article publication and the access period will remain open for 5 years.
• Access Criteria: Data will be made available to qualified researchers for meta-analysis or other secondary analyses consistent with the original aims of the study. Researchers must submit a methodologically sound proposal to the corresponding author at h.jowah@su.edu.ye. A signed data access agreement will be required prior to the release of any data.

Locations

YE (2)