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Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

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ClinicalTrials.gov Identifier: NCT01548339
Recruitment Status : Terminated
First Posted : March 8, 2012
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, 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.

Condition or disease Intervention/treatment Phase
Acute Cholecystitis Procedure: Laparoscopic cholecystectomy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Cholecystectomy for Acute Cholecystitis: is the Rule of 72 Hours Still Actual?
Study Start Date : February 2009
Actual Primary Completion Date : February 2015
Actual Study Completion Date : October 2015

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Arm Intervention/treatment
Active Comparator: Delayed
Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment
Procedure: Laparoscopic cholecystectomy
3 trocars laparoscopic cholecystectomy

Experimental: Early
Laparoscopic cholecystectomy performed directly after the initial diagnosis
Procedure: Laparoscopic cholecystectomy
3 trocars laparoscopic cholecystectomy




Primary Outcome Measures :
  1. Global morbidity [ Time Frame: 30 postoperative days ]

Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 postoperative days ]
  2. Length of stay [ Time Frame: 30 postoperative days ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • proven echographic cholecystitis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548339


Locations
Switzerland
University of Lausanne Hospitals
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Study Chair: Nicolas Demartines, MD University of Lausanne Hospitals
Study Director: Nermin Halkic, MD University of Lausanne Hospitals
Principal Investigator: Luca Di Mare, MD University of Lausanne Hospitals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nicolas DEMARTINES, Chairman of the Department of Surgery, Professor of Surgery, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01548339     History of Changes
Other Study ID Numbers: 252/08 CHV
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases