Study Stopped
Intermediary analysis showing increased morbidity in the delayed group
Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms
1 other identifier
interventional
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 5, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
February 25, 2019
CompletedAugust 6, 2020
July 1, 2020
6 years
March 5, 2012
October 24, 2018
July 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Postoperative Complications
30 postoperative days
Length of Stay
30 postoperative days
Study Arms (2)
Delayed
ACTIVE COMPARATORLaparoscopic cholecystectomy performed secondarily after an initial conservative treatment
Early
EXPERIMENTALLaparoscopic cholecystectomy performed directly after the initial diagnosis
Interventions
Eligibility Criteria
You may qualify if:
- proven echographic cholecystitis
You may not qualify if:
- pregnancy
- immunosuppression
- severe sepsis
- perforated cholecystitis
- peritonitis
- cholangitis
- acute pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Lausanne Hospitals
Lausanne, Canton of Vaud, 1011, Switzerland
Related Publications (1)
Roulin D, Saadi A, Di Mare L, Demartines N, Halkic N. Early Versus Delayed Cholecystectomy for Acute Cholecystitis, Are the 72 hours Still the Rule?: A Randomized Trial. Ann Surg. 2016 Nov;264(5):717-722. doi: 10.1097/SLA.0000000000001886.
PMID: 27741006DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. N. Demartines
- Organization
- University Hospital Lausanne
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman of the Department of Surgery, Professor of Surgery
Study Record Dates
First Submitted
March 5, 2012
First Posted
March 8, 2012
Study Start
February 1, 2009
Primary Completion
February 1, 2015
Study Completion
October 1, 2015
Last Updated
August 6, 2020
Results First Posted
February 25, 2019
Record last verified: 2020-07