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Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University of Lausanne Hospitals
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01548339
First received: March 5, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

Regarding surgical treatment of acute cholecystitis, there is a dogma that the patients should be operated within 72 hours of evolution. However, retrospective studies showed that laparoscopic cholecystectomy even after 72 hours was safe. There are randomized controlled-trials that found no difference in term of complications when comparing early to delayed cholecystectomy after acute cholecystitis, but none distinguished patients in terms of onset of symptoms.

The purpose of this study is to compare the clinical outcomes and economical issues of early versus delayed laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.


Condition Intervention
Acute Cholecystitis
Procedure: Laparoscopic cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Cholecystectomy for Acute Cholecystitis: is the Rule of 72 Hours Still Actual?

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Global morbidity [ Designated as safety issue: No ]
  • Postoperative complications [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost analysis [ Designated as safety issue: No ]

Estimated Enrollment: 466
Study Start Date: February 2009
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • proven echographic cholecystitis

Exclusion Criteria:

  • pregnancy
  • immunosuppression
  • severe sepsis
  • perforated cholecystitis
  • peritonitis
  • cholangitis
  • acute pancreatitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548339

Contacts
Contact: Luca Di Mare, MD luca.di-mare@chuv.ch

Locations
Switzerland
University of Lausanne Hospitals Recruiting
Lausanne, Vaud, Switzerland, 1011
Principal Investigator: Luca Di Mare, MD         
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
  More Information

No publications provided

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
Study First Received: March 5, 2012
Last Updated: March 5, 2012
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on November 25, 2014