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| Name | Class |
|---|---|
| Al-Thawra Modern General Hospital | OTHER |
| Al-Kuwait University Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Laparoscopic Cholecystectomy (ELC) | Experimental | Participants underwent laparoscopic cholecystectomy within 72 hours of symptom onset during the index hospital admission. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Cholecystectomy | Procedure | Standard four-port laparoscopic cholecystectomy was performed by a specialist or resident surgeon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Postoperative Complications | Incidence of any postoperative complication within 30 days | Within 30 days post-surgery |
| Conversion to Open Surgery | Rate of conversion from laparoscopic to open cholecystectomy during the procedure. | Intraoperative |
| Operative Time | Duration of surgery, measured in minutes from skin incision to skin closure. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Length of Hospital Stay | Number of days from surgery to hospital discharge. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed A Issa, Professor | Sana'a University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Kuwait University Hospital | Sanaa | Yemen | ||||
| Al-Thawra Modern General Hospital |
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.
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Data will be available beginning 3 months after article publication and the access period will remain open for 5 years.
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.
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| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| D042882 | Gallstones |
| D005705 | Gallbladder Diseases |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002769 | Cholelithiasis |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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. | Up to 30 days post-surgery |
| 30-Day Readmission Rate | Rate of unplanned hospital readmission for any cause within 30 days of discharge. | 30 days |
| Sanaa |
| Yemen |
| D041761 |
| Cholecystolithiasis |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |