Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

Lausanne University Hospital (CHUV)

Status: Terminated

Conditions: Cholecystectomy; Acute Cholecystitis

Treatments: Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01548339

252/08 CHV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• proven echographic cholecystitis

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Delayed

Active Comparator group

Description:

Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment

Treatment:

Procedure: Laparoscopic cholecystectomy

Early

Experimental group

Description:

Laparoscopic cholecystectomy performed directly after the initial diagnosis

Treatment:

Procedure: Laparoscopic cholecystectomy