Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Mansoura University
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Operative time
Study Overview
Brief Summary
The best management of the acute cholecystitis is to do laparoscopic cholecystectomy. The hypothesis is that to do it as an early intervention after patient admission is better than delayed cholecystectomy regarding the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.
Detailed Description
Doing laparoscopic cholecystectomy for patients with acute cholecystitis as an early intervention after patient admission ( first group) or to do it after a while of treatment and conservation as a delayed cholecystectomy (second group) points of study include the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Proved acute cholecystitis clinical, radiologic
Exclusion Criteria
- •Evidence of peritonitis
- •ASA III or IV
- •Previous upper abdominal surgery
- •Pregnancy
Arms & Interventions
Early cholecystectomy
Laparoscopic cholecystectomy well be done after the immediate admission
Intervention: Early cholecystectomy (Procedure)
Delayed cholecystectomy
Laparoscopic cholecystectomy after a period of conservative treatment
Intervention: Delayed cholecystectomy (Procedure)
Outcomes
Primary Outcomes
Operative time
Time Frame: 1 DAY
Operative time is assessed in minutes ,
Secondary Outcomes
- hospital stay in days(2 weeks)
- Period of giving antibiotics in days(2 WEEKS)
- Perioperative complications(5 weeks)
- Conversion rate(1 DAY)
Investigators
MOHAMED ABDELLATIF
PhD
Mansoura University