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Early Versus Interval Laparoscopic Cholecystectomy for Acute Cholecystitis

NCT07021300 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-06-13

No results posted yet for this study

Summary

This study compares two different timing approaches for gallbladder removal surgery in patients with acute gallbladder inflammation (acute cholecystitis).

When someone develops acute cholecystitis, doctors need to remove the gallbladder using a minimally invasive technique called laparoscopic surgery. However, there is ongoing debate about the best timing for this surgery. Some doctors prefer to operate early (within 3 days of diagnosis), while others prefer to wait and operate later (after 4 weeks of medical treatment).

In this study, we randomly assigned 166 patients with acute cholecystitis to receive either:

* Early surgery: Laparoscopic gallbladder removal within 72 hours of diagnosis
* Delayed surgery: Laparoscopic gallbladder removal after 4 weeks of antibiotic treatment

All surgeries were performed by the same experienced surgeon using standard techniques. We measured how long each surgery took, how many days patients stayed in the hospital, and how often the surgeon needed to switch from the minimally invasive approach to open surgery.

The study found that patients who had early surgery had shorter operation times, went home from the hospital sooner, and were less likely to need open surgery compared to patients who waited 4 weeks for their operation.

This research helps doctors and patients make better decisions about the timing of gallbladder surgery when someone has acute cholecystitis.

Conditions

Interventions

PROCEDURE

Early Laparoscopic Cholecystectomy

A standard four-port laparoscopic cholecystectomy performed within 72 hours of diagnosis of acute cholecystitis. Surgery is done under general anesthesia by an experienced surgeon. This group receives no prolonged preoperative conservative management. Timing aligns with Tokyo Guidelines 2013 recommendation for early intervention

PROCEDURE

Interval Laparoscopic Cholecystectomy

A standard four-port laparoscopic cholecystectomy performed after 4 weeks of initial conservative management with antibiotics and analgesics. The procedure is conducted under general anesthesia by the same experienced surgeon, using the same technique as the early group. This approach represents delayed surgical management per traditional protocols.

Sponsors & Collaborators

  • Lady Reading Hospital, Pakistan

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07021300 on ClinicalTrials.gov