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

Sponsor

Mansoura University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02130245

Collaborator

(none)

600

Enrollment

Location

Arms

Duration (Months)

21.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cholecystitis	Procedure: Early cholecystectomy Procedure: Delayed cholecystectomy	N/A

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

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Early cholecystectomy Laparoscopic cholecystectomy well be done after the immediate admission	Procedure: Early cholecystectomy Early laparoscopic cholecystectomy for acute cholecystitis after admission Other Names: First group
Active Comparator: Delayed cholecystectomy Laparoscopic cholecystectomy after a period of conservative treatment	Procedure: Delayed cholecystectomy Laparoscopic cholecystectomy well be done after a period on conservation Other Names: Second group

Arm

Intervention/Treatment

Active Comparator: Early cholecystectomy

Laparoscopic cholecystectomy well be done after the immediate admission

Procedure: Early cholecystectomy

Early laparoscopic cholecystectomy for acute cholecystitis after admission

Other Names:

First group

Active Comparator: Delayed cholecystectomy

Laparoscopic cholecystectomy after a period of conservative treatment

Procedure: Delayed cholecystectomy

Laparoscopic cholecystectomy well be done after a period on conservation

Other Names:

Second group

Outcome Measures

Primary Outcome Measures

Operative time [1 DAY]
Operative time is assessed in minutes ,

Secondary Outcome Measures

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