Acute Cholecystitis
Conditions
Keywords
Laparoscopic Cholecystectomy, Gallstones, Biliary Disease, Surgical Timing
Brief 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). 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: 1. An early surgery group 2. 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.
Interventions
PROCEDURELaparoscopic Cholecystectomy
Standard four-port laparoscopic cholecystectomy was performed by a specialist or resident surgeon.
Sponsors
Al-Thawra Modern General Hospital
Al-Kuwait University Hospital
Sana'a University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Postoperative Complications | Within 30 days post-surgery | Incidence of any postoperative complication within 30 days |
| Conversion to Open Surgery | Intraoperative | Rate of conversion from laparoscopic to open cholecystectomy during the procedure. |
| Operative Time | Intraoperative | Duration of surgery, measured in minutes from skin incision to skin closure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Length of Hospital Stay | Up to 30 days post-surgery | Number of days from surgery to hospital discharge. |
| 30-Day Readmission Rate | 30 days | Rate of unplanned hospital readmission for any cause within 30 days of discharge. |
| Duration of Postoperative Pain | Up to 30 days post-surgery | Number of days from surgery until the participant was free of the need for analgesic medication. |
| Time to Return to Normal Daily Activities | Up to 30 days post-surgery | Number of days from surgery until the participant reported a full return to normal daily activities. |
Countries
Yemen
Outcome results
None listed