Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days
- Conditions
- Acute Calculous Cholecystitis
- Interventions
- Procedure: Laparoscopic cholecystectomy
- Registration Number
- NCT03477253
- Lead Sponsor
- Assiut University
- Brief Summary
This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset.
- Detailed Description
The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as surgical management of acute calculous cholecystitis within and after 72h of symptom onset.
This study included 62 patients with acute calculous cholecystitis. Patients are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms and categorized as Group A \& B. Immediate laparoscopic cholecystectomy is performed in Group A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups monitored since admission, during operations, and along the postoperative period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- Abdominal pain characteristic of Acute Cholecystitis, Positive Murphy's sign, Total Leucocyte Count > 10,000/ uL, and (4) Ultra-sonographic evidence of Acute Calculous Cholecystitis.
- Initial surgical management planned for immediate laparoscopic cholecystectomy.
- Patients who are fit for laparoscopy and general anesthesia.
- Patient who agree to provide short term outcome data and agree to provide contact information.
- Patients with ultra-sonographic findings of common bile duct calculi, pancreatitis, gall bladder perforation, gall bladder gangrene or gall bladder abscess.
- Patients with other associated abdominal pathology.
- Patients with any previous abdominal surgery or any significant systemic disease.
- Septic shock.
- Pregnancy/ Breast-feeding mothers.
- Participation in an additional drug or device study and inability to offer informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LC within 72 hours of disease onset Laparoscopic cholecystectomy Immediate laparoscopic cholecystectomy within 72 hours of the onset of symptoms was performed in these patients LC after 72 hours of disease onset Laparoscopic cholecystectomy Late laparoscopic cholecystectomy after 72 hours of the onset of symptoms was performed in these patients
- Primary Outcome Measures
Name Time Method Comparison between early and late laparoscopic cholecystectomy regarding Operation time intra-operative comparing the needed intra-operative time for laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis , time will be measured by minutes
Duration of postoperative hospital stay within 2 weeks post-operative comparing post-operative duration of hospital stay after laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis ,duration will be measured by post operative days spent in the hospital
Comparison between early and late laparoscopic cholecystectomy regarding difficulty of operation intra-operative comparing the difficulty of laparoscopic cholecystectomy within and after 3 days of the onset of acute calculous cholecystitis, difficulty will be assessed by the rate of conversion to open cholecystectomy
comparison between early and late laparoscopic cholecystectomy regarding post operative pain within 1month post operative comparing between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and duration of post operative pain , pain will be measured by either the pain responded to regular NSAIDs or needed the administration of narcotics
- Secondary Outcome Measures
Name Time Method comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding 7 days postoperative compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of postoperative bleeding
presence of any wound complication by examining the wound within 10 days post-operative comparison between early and late laparoscopic cholecystectomy concerning the presence and rate of wound infection by clinical examination post-operative
comparison between early and late laparoscopic cholecystectomy regarding post operative bile leakage first 72 hours post-operative compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of bile leakage
Trial Locations
- Locations (1)
Assiut University
🇪🇬Assiut, Egypt