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Completed

NCT Number: NCT07101315

Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Kuwait University Hospital, Sanaa, Yemen

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

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

Primary outcomes

  1. Overall Postoperative Complications

    Time frame: Within 30 days post-surgery

    Incidence of any postoperative complication within 30 days

  2. Conversion to Open Surgery

    Time frame: Intraoperative

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

  3. Operative Time

    Time frame: Intraoperative

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

Secondary outcomes

  1. Postoperative Length of Hospital Stay

    Time frame: Up to 30 days post-surgery

    Number of days from surgery to hospital discharge.

  2. Duration of Postoperative Pain

    Time frame: Up to 30 days post-surgery

    Number of days from surgery until the participant was free of the need for analgesic medication.

  3. Time to Return to Normal Daily Activities

    Time frame: Up to 30 days post-surgery

    Number of days from surgery until the participant reported a full return to normal daily activities.

  4. 30-Day Readmission Rate

    Time frame: 30 days

    Rate of unplanned hospital readmission for any cause within 30 days of discharge.

Sponsors and collaborators

Lead sponsor

Sana'a University

Other

Collaborators

  • Al-Kuwait University Hospital
  • Al-Thawra Modern General Hospital

Registry information

Official study title

Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis: A Prospective Study Adjusting for Confounding by Indication

Acronym: EDLC-AC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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