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

NCT ID: NCT02130245

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Acute Cholecystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early cholecystectomy

Laparoscopic cholecystectomy well be done after the immediate admission

Group Type ACTIVE_COMPARATOR

Early cholecystectomy

Intervention Type PROCEDURE

Early laparoscopic cholecystectomy for acute cholecystitis after admission

Delayed cholecystectomy

Laparoscopic cholecystectomy after a period of conservative treatment

Group Type ACTIVE_COMPARATOR

Delayed cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy well be done after a period on conservation

Interventions

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Early cholecystectomy

Early laparoscopic cholecystectomy for acute cholecystitis after admission

Intervention Type PROCEDURE

Delayed cholecystectomy

Laparoscopic cholecystectomy well be done after a period on conservation

Intervention Type PROCEDURE

Other Intervention Names

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First group Second group

Eligibility Criteria

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Inclusion Criteria

* Proved acute cholecystitis clinical, radiologic

Exclusion Criteria

* Evidence of peritonitis
* ASA III or IV
* Previous upper abdominal surgery
* Pregnancy
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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MOHAMED ABDELLATIF

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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mansoura university hospital, EGYPT, central hafr elbatin hospital, Saudia Arabia

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamed e abdellatif, md

Role: CONTACT

00201115051680

Facility Contacts

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mohamed E abd ellatif, PhD

Role: primary

00966543973660

Related Links

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Other Identifiers

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Early cholecystectomy

Identifier Type: -

Identifier Source: org_study_id

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