Acute CholecystitisEDLC-ACNCT07101315
Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis
A study testing Laparoscopic Cholecystectomy in people with Acute Cholecystitis, run by Sana'a University at 2 sites in Yemen.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesYemen
- Study dates
- 1 Jan 2022to 30 Dec 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Yemen2 sites
Al-Kuwait University Hospital
Sanaa
Al-Thawra Modern General Hospital
Sanaa
About this study
Official title: Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis: A Prospective Study Adjusting for Confounding by Indication
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?
Read more
Researchers will compare two groups:
- An early surgery group
- 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.
- Conditions
- Acute Cholecystitis
- Being tested
- Laparoscopic Cholecystectomy
- Keywords
- Laparoscopic Cholecystectomy, Gallstones, Biliary Disease, Surgical Timing
- Medical subject headings
- Cholecystitis, Acute, Gallstones, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic CholecystectomyProcedure or surgery
Standard four-port laparoscopic cholecystectomy was performed by a specialist or resident surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Early Laparoscopic Cholecystectomy (ELC) | Experimental | Participants underwent laparoscopic cholecystectomy within 72 hours of symptom onset during the index hospital admission. Receives: Procedure: Laparoscopic Cholecystectomy |
| Delayed Laparoscopic Cholecystectomy (DLC) | Active comparator | Participants received initial non-operative management with antibiotics and analgesics, followed by elective laparoscopic cholecystectomy 6-8 weeks later. Receives: Procedure: Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Postoperative Complications
Incidence of any postoperative complication within 30 days
Measured: Within 30 days post-surgery
Conversion to Open Surgery
Rate of conversion from laparoscopic to open cholecystectomy during the procedure.
Measured: Intraoperative
Operative Time
Duration of surgery, measured in minutes from skin incision to skin closure.
Measured: Intraoperative
Secondary outcomes (4)
Postoperative Length of Hospital Stay
Number of days from surgery to hospital discharge.
Measured: Up to 30 days post-surgery
Duration of Postoperative Pain
Number of days from surgery until the participant was free of the need for analgesic medication.
Measured: Up to 30 days post-surgery
Time to Return to Normal Daily Activities
Number of days from surgery until the participant reported a full return to normal daily activities.
Measured: Up to 30 days post-surgery
30-Day Readmission Rate
Rate of unplanned hospital readmission for any cause within 30 days of discharge.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jan 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Thawra Modern General Hospital, Al-Kuwait University Hospital
- Responsible party
- Principal investigator, Haitham Mohammed Jowah, Sana'a University
- Investigators
- Mohammed A Issa, Professor, Principal investigator, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101315
- Sponsor's protocol ID
- SanaaU-Chole-001
- Acronym
- EDLC-AC
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article, after publication. This includes data for all primary and secondary outcome measures. The study protocol will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis: A Prospective Study Adjusting for Confounding by Indication
- ClinicalTrials.gov ID
- NCT07101315
- Acronym / sponsor ID
- EDLC-AC / SanaaU-Chole-001
- Conditions
- Acute Cholecystitis
- Keywords
- Laparoscopic Cholecystectomy, Gallstones, Biliary Disease, Surgical Timing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Collaborators
- Al-Thawra Modern General Hospital, Al-Kuwait University Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 3 Aug 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.
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:
- An early surgery group
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Laparoscopic Cholecystectomy (ELC) | Experimental | Procedure: Laparoscopic CholecystectomyParticipants underwent laparoscopic cholecystectomy within 72 hours of symptom onset during the index hospital admission. |
| Delayed Laparoscopic Cholecystectomy (DLC) | Active comparator | Procedure: Laparoscopic CholecystectomyParticipants received initial non-operative management with antibiotics and analgesics, followed by elective laparoscopic cholecystectomy 6-8 weeks later. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Laparoscopic CholecystectomyStandard four-port laparoscopic cholecystectomy was performed by a specialist or resident surgeon. | Procedure or surgery | Delayed Laparoscopic Cholecystectomy (DLC), Early Laparoscopic Cholecystectomy (ELC) |
Primary outcome
Overall Postoperative Complications
Time frame: Within 30 days post-surgery
Incidence of any postoperative complication within 30 days
Conversion to Open Surgery
Time frame: Intraoperative
Rate of conversion from laparoscopic to open cholecystectomy during the procedure.
Operative Time
Time frame: Intraoperative
Duration of surgery, measured in minutes from skin incision to skin closure.
4 secondary outcomes
Postoperative Length of Hospital Stay
Time frame: Up to 30 days post-surgery
Duration of Postoperative Pain
Time frame: Up to 30 days post-surgery
Time to Return to Normal Daily Activities
Time frame: Up to 30 days post-surgery
30-Day Readmission Rate
Time frame: 30 days
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 3 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article, after publication. This includes data for all primary and secondary outcome measures. The study protocol will not be shared.
Related trials for Acute Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
Cholecystitis, Acute, Biliary Diseases
Recruiting
Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage
Acute Cholecystitis
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.
Mohammed A Issa, Professor principal investigator
Sana'a University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Cholecystectomy in people with Acute Cholecystitis, run by Sana'a University at 2 sites in Yemen.
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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Yemen. 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?
Overall Postoperative Complications (time frame: Within 30 days post-surgery). The study lists 3 primary outcomes in all. 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 3 Aug 2025.