An interventional study of Laparoscopic Cholecystectomy in Acute Cholecystitis, sponsored by Sana'a University. Completed at 2 sites in Yemen. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Sana'a University · Not applicable, Interventional, and Treatment
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:
Researchers will compare two groups:
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.
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
This study's enrollment of 81 is close to the median of 90 across 84 interventional studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →Sana'a University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants underwent laparoscopic cholecystectomy within 72 hours of symptom onset during the index hospital admission.
Procedure: Laparoscopic Cholecystectomy
Participants received initial non-operative management with antibiotics and analgesics, followed by elective laparoscopic cholecystectomy 6-8 weeks later.
Procedure: Laparoscopic Cholecystectomy
Standard four-port laparoscopic cholecystectomy was performed by a specialist or resident surgeon.
Overall Postoperative Complications
Incidence of any postoperative complication within 30 days
Time frame: Within 30 days post-surgery
Conversion to Open Surgery
Rate of conversion from laparoscopic to open cholecystectomy during the procedure.
Time frame: Intraoperative
Operative Time
Duration of surgery, measured in minutes from skin incision to skin closure.
Time frame: Intraoperative
Postoperative Length of Hospital Stay
Number of days from surgery to hospital discharge.
Time frame: 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.
Time frame: 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.
Time frame: Up to 30 days post-surgery
30-Day Readmission Rate
Rate of unplanned hospital readmission for any cause within 30 days of discharge.
Time frame: 30 days
Plan to share: 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.
Time frame: Data will be available beginning 3 months after article publication and the access period will remain open for 5 years.
Access criteria: Data will be made available to qualified researchers for meta-analysis or other secondary analyses consistent with the original aims of the study. Researchers must submit a methodologically sound proposal to the corresponding author at h.jowah@su.edu.ye. A signed data access agreement will be required prior to the release of any data.
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Dec 2023, 23 months.
Of 42 non-industry interventional studies with no phase under Cholecystitis, Acute, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's 23 months is above that.
Counting every sponsor, half of 45 studies reached it within 20 months; a quarter within 9 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Sana'a University