An interventional study of Early Laparoscopic Cholecystectomy and Interval Laparoscopic Cholecystectomy in Acute Cholecystitis, Cholelithiasis and Gallbladder Diseases, sponsored by Lady Reading Hospital, Pakistan. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Lady Reading Hospital, Pakistan · Not applicable, Interventional, and Treatment
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:
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.
This randomized controlled trial was designed to address the clinical question of optimal timing for laparoscopic cholecystectomy in acute cholecystitis, a condition affecting thousands of patients annually worldwide. The study was conducted in response to conflicting evidence and varying clinical practices regarding surgical timing.
Study Design and Setting:
The trial employed a parallel-group, single-blind randomized controlled design conducted at the General Surgery Department of Lady Reading Hospital, a tertiary care teaching hospital in Pakistan. The study period extended from May 1, 2024, to December 31, 2024, with comprehensive follow-up until patient discharge.
**Randomization and Blinding:** Participants were allocated using blocked randomization to ensure equal group sizes throughout the recruitment period. While complete blinding was not feasible due to the nature of the intervention, outcome assessors were blinded to group allocation during data collection. A computer-generated randomization sequence was used, with allocation concealment maintained through sealed opaque envelopes.
Intervention Protocols:
Group A (Early LC) patients underwent laparoscopic cholecystectomy within 72 hours of acute cholecystitis diagnosis. These patients were admitted, prepared for surgery with standard pre-operative protocols, and underwent surgery during the acute inflammatory phase.
Group B (Interval LC) patients received initial conservative management with intravenous antibiotics, analgesics, and supportive care during their index admission. After clinical improvement and discharge, they returned after 4 weeks for elective laparoscopic cholecystectomy during the quiescent phase.
Surgical Technique:
All procedures followed standardized protocols using the critical view of safety technique. The four-port approach included an umbilical port for the camera, a subxiphoid port for retraction, and two ports below the right costal margin for dissection and clipping. Calot's triangle dissection followed established principles with careful identification of the hepatocystic artery and cystic artery before clipping and division.
Outcome Measurement:
Primary outcomes were measured using standardized protocols. Operative time was recorded from anesthesia induction to complete abdominal wall closure using calibrated stopwatches. Hospital stay was calculated from surgery completion to consultant discharge decision. Conversion to open surgery was documented when the surgeon determined laparoscopic completion was unsafe or technically impossible.
**Quality Assurance:** A dedicated research fellow was assigned to each case for real-time data collection, ensuring accuracy and completeness. All procedures were performed by a single consultant surgeon with over five years of laparoscopic experience, eliminating surgeon-related variability. Post-operative care followed standardized protocols with daily assessments by the surgical team.
Statistical Considerations:
Sample size calculation was based on anticipated conversion rates from previous literature, with 80% power to detect a clinically meaningful difference. Effect modification analysis was pre-planned for key demographic and clinical variables to identify potential subgroup effects.
The study protocol received institutional review board approval and was conducted in accordance with Declaration of Helsinki principles, with comprehensive informed consent obtained from all participants.
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
This study's enrollment of 166 is above the median of 90 across 84 interventional studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →Lady Reading Hospital, Pakistan is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Operative Time
Operative time measured in minutes from anesthesia induction to complete closure of the abdominal wall, recorded using a standardized stopwatch protocol.
Time frame: Intraoperatively (from anesthesia induction to closure of abdominal wall, assessed once during the surgery)
Length of Hospital Stay
Postoperative hospital stay measured in full days from the time of surgery until the consultant surgeon's discharge decision.
Time frame: Postoperatively (from end of surgery to discharge, assessed once at discharge)
Conversion to Open Surgery
Proportion of laparoscopic cholecystectomy cases that were converted to open cholecystectomy, as determined intraoperatively by the operating surgeon.
Time frame: Intraoperatively (assessed during the surgical procedure)
Plan to share: No — Individual participant data (IPD) will not be shared because the study was not designed with data sharing agreements or participant consent for secondary data use. Ethical and institutional restrictions prevent public data release.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Lady Reading Hospital, Pakistan