Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

NCT ID: NCT01548339

Last Updated: 2020-08-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study is to compare the clinical outcomes of early versus delayed laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.

Detailed Description

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In acute biliary cholecystitis, there was a dogma that patients should be operated within 72 hours of evolution. However, retrospective studies suggested that laparoscopic cholecystectomy even after 72 hours was safe. Moreover, some randomized controlled-trials did not found any differences in term of complications between early and delayed cholecystectomy, however none of these studies did separate patients according to the onset of symptoms. The aim of our present study was to compare the clinical outcomes of immediate versus delayed cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.

Conditions

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Acute Cholecystitis Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Delayed

Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

3 trocars laparoscopic cholecystectomy

Early

Laparoscopic cholecystectomy performed directly after the initial diagnosis

Group Type EXPERIMENTAL

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

3 trocars laparoscopic cholecystectomy

Interventions

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Laparoscopic cholecystectomy

3 trocars laparoscopic cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* proven echographic cholecystitis

Exclusion Criteria

* pregnancy
* immunosuppression
* severe sepsis
* perforated cholecystitis
* peritonitis
* cholangitis
* acute pancreatitis
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Nicolas DEMARTINES

Chairman of the Department of Surgery, Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas Demartines, MD

Role: STUDY_CHAIR

University of Lausanne Hospitals

Nermin Halkic, MD

Role: STUDY_DIRECTOR

University of Lausanne Hospitals

Luca Di Mare, MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

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University of Lausanne Hospitals

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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Roulin D, Saadi A, Di Mare L, Demartines N, Halkic N. Early Versus Delayed Cholecystectomy for Acute Cholecystitis, Are the 72 hours Still the Rule?: A Randomized Trial. Ann Surg. 2016 Nov;264(5):717-722. doi: 10.1097/SLA.0000000000001886.

Reference Type DERIVED
PMID: 27741006 (View on PubMed)

Other Identifiers

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252/08 CHV

Identifier Type: -

Identifier Source: org_study_id

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