Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

Acute Cholecystitis Clinical Trial

Official title:

Laparoscopic Cholecystectomy for Acute Cholecystitis: is the Rule of 72 Hours Still Actual?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01548339
• Other study ID #: 252/08 CHV
• Status: Terminated
• Phase: N/A
• Start date: February 2009
• Est. completion date: October 2015

Study information

• Verified date: July 2020
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: October 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• proven echographic cholecystitis

Exclusion Criteria:

• pregnancy

• immunosuppression

• severe sepsis

• perforated cholecystitis

• peritonitis

• cholangitis

• acute pancreatitis

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystectomy
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Laparoscopic cholecystectomy
3 trocars laparoscopic cholecystectomy

Locations

Country	Name	City	State
Switzerland	University of Lausanne Hospitals	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Event ("Global Morbidity").	any adverse event occurring from time of diagnosis until the 30th postoperative day	30 postoperative days
Secondary	Postoperative Complications	postoperative complications graded according to Clavien classification	30 postoperative days
Secondary	Length of Stay	total in hospital stay	30 postoperative days