Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

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Brief Title

Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

Official Title

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

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 Type

Interventional

Primary Outcome

Number of Participants With Adverse Event ("Global Morbidity").

Secondary Outcome

 Postoperative Complications

Condition

Acute Cholecystitis

Intervention

Laparoscopic cholecystectomy

Study Arms / Comparison Groups

 Delayed
Description:  Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

86

Start Date

February 2009

Completion Date

October 2015

Primary Completion Date

February 2015

Eligibility Criteria

        Inclusion Criteria:

          -  proven echographic cholecystitis

        Exclusion Criteria:

          -  pregnancy

          -  immunosuppression

          -  severe sepsis

          -  perforated cholecystitis

          -  peritonitis

          -  cholangitis

          -  acute pancreatitis

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nicolas Demartines, MD, ,

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations

NCT ID

NCT01548339

Organization ID

252/08 CHV

Responsible Party

Principal Investigator

Study Sponsor

University of Lausanne Hospitals

Study Sponsor

Nicolas Demartines, MD, Study Chair, University of Lausanne Hospitals

Verification Date

July 2020