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

April 7, 2015 updated by: MOHAMED ABDELLATIF, Mansoura University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura,, Egypt
        • Recruiting
        • mansoura university hospital, EGYPT, central hafr elbatin hospital, Saudia Arabia
        • Contact:
        • Principal Investigator:
          • mohamed e abd ellatif, phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Proved acute cholecystitis clinical, radiologic

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: 1 DAY
Operative time is assessed in minutes ,
1 DAY

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimate)

May 5, 2014

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Early cholecystectomy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Cholecystitis

Clinical Trials on Early cholecystectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe