Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

Not Applicable

Terminated

• Conditions: Acute Cholecystitis; Cholecystectomy
• Interventions: Procedure: Laparoscopic cholecystectomy

• Registration Number: NCT01548339
• Lead Sponsor: University of Lausanne Hospitals

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-08
• Primary Completion: 2015-02
• Study Completion: 2015-10
• Results First Submitted: 2018-10-24
• Results First Submitted QC: 2018-10-24
• Results First Posted: 2019-02-25
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• proven echographic cholecystitis

Exclusion Criteria

• pregnancy
• immunosuppression
• severe sepsis
• perforated cholecystitis
• peritonitis
• cholangitis
• acute pancreatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed	Laparoscopic cholecystectomy	Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment
Early	Laparoscopic cholecystectomy	Laparoscopic cholecystectomy performed directly after the initial diagnosis

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Event ("Global Morbidity").	30 postoperative days	any adverse event occurring from time of diagnosis until the 30th postoperative day

Secondary Outcome Measures

Name	Time	Method
Postoperative Complications	30 postoperative days	postoperative complications graded according to Clavien classification
Length of Stay	30 postoperative days	total in hospital stay

Trial Locations

Locations (1)

University of Lausanne Hospitals; 🇨🇭 Lausanne, Vaud, Switzerland