Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study

Not Applicable

• Conditions: Acute Cholecystitis
• Interventions: Procedure: Early cholecystectomy; Procedure: Delayed cholecystectomy

• Registration Number: NCT02130245
• Lead Sponsor: Mansoura University

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Proved acute cholecystitis clinical, radiologic

Exclusion Criteria

• Evidence of peritonitis
• ASA III or IV
• Previous upper abdominal surgery
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early cholecystectomy	Early cholecystectomy	Laparoscopic cholecystectomy well be done after the immediate admission
Delayed cholecystectomy	Delayed cholecystectomy	Laparoscopic cholecystectomy after a period of conservative treatment

Primary Outcome Measures

Name	Time	Method
Operative time	1 DAY	Operative time is assessed in minutes ,

Secondary Outcome Measures

Name	Time	Method
hospital stay in days	2 weeks	hospital stay in days
Period of giving antibiotics in days	2 WEEKS	Number of days giving the antibiotics
Perioperative complications	5 weeks	Intraoperative complications like bleeding , injury,
Conversion rate	1 DAY	Conversion rate from laparoscopic to open and reason of conversion.

Trial Locations

Locations (1)

mansoura university hospital, EGYPT, central hafr elbatin hospital, Saudia Arabia; 🇪🇬 Mansoura,, Egypt