Early Versus Interval Laparoscopic Cholecystectomy for Acute Cholecystitis

NCT07021300 | Completed

• 2 other identifiers: Ref: No. 863/LRH/ MTI863/LRH/MTI
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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

Acute Cholecystitis; Cholelithiasis; Gallbladder Diseases

Keywords

Randomized controlled trial; Laparoscopic cholecystectomy; Acute cholecystitis; Early surgery; Delayed surgery

Outcome Measures

Primary Outcomes (1)

• Operative Time

  Operative time measured in minutes from anesthesia induction to complete closure of the abdominal wall, recorded using a standardized stopwatch protocol.

  Intraoperatively (from anesthesia induction to closure of abdominal wall, assessed once during the surgery)

Secondary Outcomes (2)

• Length of Hospital Stay

  Postoperatively (from end of surgery to discharge, assessed once at discharge)

• Conversion to Open Surgery

  Intraoperatively (assessed during the surgical procedure)

Study Arms (2)

Early Laparoscopic Cholecystectomy

EXPERIMENTAL

Patients in this arm will undergo laparoscopic cholecystectomy within 72 hours of diagnosis of acute cholecystitis. Surgery will be performed using a standard four-port technique under general anesthesia by an experienced surgeon.

Procedure: Early Laparoscopic Cholecystectomy

Interval Laparoscopic Cholecystectomy

ACTIVE COMPARATOR

Patients in this arm will receive initial conservative management, including antibiotics and analgesics, followed by laparoscopic cholecystectomy performed after 4 weeks. The surgery will also follow the standard four-port technique under general anesthesia.

Procedure: Interval Laparoscopic Cholecystectomy

Interventions

Early Laparoscopic Cholecystectomy PROCEDURE

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

Also known as: Early LC

Early Laparoscopic Cholecystectomy

Interval Laparoscopic Cholecystectomy PROCEDURE

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.

Also known as: Interval LC

Interval Laparoscopic Cholecystectomy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 20 and 60 years
• Diagnosis of acute cholecystitis confirmed by history (right hypochondrial pain \<5 days), clinical examination (tenderness in right hypochondrium), and ultrasound (thickened fibrosed gallbladder wall)
• Presentation within 24 hours of symptom onset
• ASA physical status class I or II
• Provided written informed consent

You may not qualify if:

• Patients with stones in the common bile duct on ultrasound
• Patients with empyema of the gallbladder on ultrasound
• Severe comorbidities (e.g., uncontrolled diabetes, ASA class III or higher)
• Pregnancy
• Previous upper abdominal surgery
• Refusal to participate

Sponsors & Collaborators

• Lady Reading Hospital, Pakistan: lead

Study Sites (1)

Lady Reading Hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Cholecystitis, Acute; Cholelithiasis; Gallbladder Diseases

Condition Hierarchy (Ancestors)

Cholecystitis; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors collecting data on operative time, hospital stay, and conversion rates were blinded to group allocation. Complete blinding of participants and surgeons was not feasible due to the nature of the surgical timing intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar

Model Details: Participants are randomly assigned to one of two parallel groups: early laparoscopic cholecystectomy (within 72 hours) or interval laparoscopic cholecystectomy (after 4 weeks).

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 13, 2025
• Study Start: May 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)