Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis (EDLC-AC)

Sana'a University

Status: Completed

Conditions: Acute Cholecystitis

Treatments: Procedure: Laparoscopic Cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07101315

SanaaU-Chole-001

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

81 participants in 2 patient groups

Early Laparoscopic Cholecystectomy (ELC)

Experimental group

Description:

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

Treatment:

Procedure: Laparoscopic Cholecystectomy

Delayed Laparoscopic Cholecystectomy (DLC)

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic Cholecystectomy