Acute CholecystitisEILCNCT07021300
Early Versus Interval Laparoscopic Cholecystectomy for Acute Cholecystitis
A study testing Early Laparoscopic Cholecystectomy and Interval Laparoscopic Cholecystectomy in people with Acute Cholecystitis and Cholelithiasis, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Acute Cholecystitis, Cholelithiasis, Gallbladder Diseases
- What is being tested?
- Early Laparoscopic Cholecystectomy and Interval Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Acute Cholecystitis, Cholelithiasis, Gallbladder Diseases
- Being tested
- Early Laparoscopic Cholecystectomy, Interval Laparoscopic Cholecystectomy
- Keywords
- Randomized controlled trial, Laparoscopic cholecystectomy, Acute cholecystitis, Early surgery, Delayed surgery
- Medical subject headings
- Cholecystitis, Acute, Cholelithiasis, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Laparoscopic CholecystectomyProcedure or surgery
Also called Early LC
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
Interval Laparoscopic CholecystectomyProcedure or surgery
Also called Interval 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Interval Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Operative time measured in minutes from anesthesia induction to complete closure of the abdominal wall, recorded using a standardized stopwatch protocol.
Measured: Intraoperatively (from anesthesia induction to closure of abdominal wall, assessed once during the surgery)
Secondary outcomes (2)
Length of Hospital Stay
Postoperative hospital stay measured in full days from the time of surgery until the consultant surgeon's discharge decision.
Measured: 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.
Measured: Intraoperatively (assessed during the surgical procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 May 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel groups: early laparoscopic cholecystectomy (within 72 hours) or interval laparoscopic cholecystectomy (after 4 weeks).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Reading Hospital, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Waseem Ullah, Lady Reading Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021300
- Sponsor's protocol ID
- Ref: No. 863/LRH/ MTI
- Other IDs
- 863/LRH/MTI
- Acronym
- EILC
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Interval Laparoscopic Cholecystectomy for Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT07021300
- Acronym / sponsor ID
- EILC / Ref: No. 863/LRH/ MTI
- Conditions
- Acute Cholecystitis, Cholelithiasis, Gallbladder Diseases
- Keywords
- Randomized controlled trial, Laparoscopic cholecystectomy, Acute cholecystitis, Early surgery, Delayed surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Lady Reading Hospital, PakistanOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups: early laparoscopic cholecystectomy (within 72 hours) or interval laparoscopic cholecystectomy (after 4 weeks).
| Arm | Type | Receives |
|---|---|---|
| Early Laparoscopic Cholecystectomy | Experimental | Procedure: Early Laparoscopic CholecystectomyPatients 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. |
| Interval Laparoscopic Cholecystectomy | Active comparator | Procedure: Interval Laparoscopic CholecystectomyPatients 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Laparoscopic CholecystectomyAlso: Early LCA 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 or surgery | Early Laparoscopic Cholecystectomy |
| Interval Laparoscopic CholecystectomyAlso: Interval LCA 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. | Procedure or surgery | Interval Laparoscopic Cholecystectomy |
Primary outcome
Operative Time
Time frame: Intraoperatively (from anesthesia induction to closure of abdominal wall, assessed once during the surgery)
Operative time measured in minutes from anesthesia induction to complete closure of the abdominal wall, recorded using a standardized stopwatch protocol.
2 secondary outcomes
Length of Hospital Stay
Time frame: Postoperatively (from end of surgery to discharge, assessed once at discharge)
Conversion to Open Surgery
Time frame: Intraoperatively (assessed during the surgical procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: 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.
Related trials for Acute Cholecystitis
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Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
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RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
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Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Laparoscopic Cholecystectomy and Interval Laparoscopic Cholecystectomy in people with Acute Cholecystitis and Cholelithiasis, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Time (time frame: Intraoperatively (from anesthesia induction to closure of abdominal wall, assessed once during the surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.