Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

NCT ID: NCT07101315

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-30

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.

Conditions

Acute Cholecystitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Laparoscopic Cholecystectomy (ELC)

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

Group Type: EXPERIMENTAL

Laparoscopic Cholecystectomy

Intervention Type: PROCEDURE

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

Delayed Laparoscopic Cholecystectomy (DLC)

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

Group Type: ACTIVE_COMPARATOR

Laparoscopic Cholecystectomy

Intervention Type: PROCEDURE

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

Interventions

Laparoscopic Cholecystectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Thawra Modern General Hospital

OTHER

Sponsor Role: collaborator

Al-Kuwait University Hospital

UNKNOWN

Sponsor Role: collaborator

Sana'a University

OTHER

Sponsor Role: lead

Responsible Party

Haitham Mohammed Jowah

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed A Issa, Professor

Role: PRINCIPAL_INVESTIGATOR

Sana'a University

Locations

Al-Kuwait University Hospital

Sanaa, , Yemen

Al-Thawra Modern General Hospital

Sanaa, , Yemen

Countries

Yemen

Other Identifiers

SanaaU-Chole-001

Identifier Type: -

Identifier Source: org_study_id