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NCT02130245 Clinical Trial

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

Acute Cholecystitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02130245
Other study ID # Early cholecystectomy
Secondary ID
Status Recruiting
Phase N/A
First received April 21, 2014
Last updated April 7, 2015
Start date September 2013
Est. completion date January 2016

Study information
Verified date April 2015
Source Mansoura University
Contact mohamed e abdellatif, md
Phone 00201115051680
Email surg_latif@hotmail.com
Is FDA regulated No
Health authority Saudi Arabia: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Proved acute cholecystitis clinical, radiologic

Exclusion Criteria:

- Evidence of peritonitis

- ASA III or IV

- Previous upper abdominal surgery

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Early cholecystectomy
Early laparoscopic cholecystectomy for acute cholecystitis after admission
• Delayed cholecystectomy
Laparoscopic cholecystectomy well be done after a period on conservation

Locations
Country Name City State
Egypt mansoura university hospital, EGYPT, central hafr elbatin hospital, Saudia Arabia Mansoura,

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Operative time Operative time is assessed in minutes , 1 DAY Yes
Secondary Perioperative complications Intraoperative complications like bleeding , injury, 5 weeks Yes
Secondary Conversion rate Conversion rate from laparoscopic to open and reason of conversion. 1 DAY Yes
Secondary hospital stay in days hospital stay in days 2 weeks Yes
Secondary Period of giving antibiotics in days Number of days giving the antibiotics 2 WEEKS Yes
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