Brief Title
The Real World of Acute Cholecystitis
Official Title
When Results of Randomised Controlled Trials and Population Based Studies do Not Reflect the Real World: A Cohort Study in Acute Cholecystitis
Brief Summary
Meta-analysis of randomized controlled trials and population based studies in acute cholecystitis are in favor for early laparoscopic surgery versus a delayed operation several weeks later. The main problems in these studies are the exclusion criteria used, thus not reflecting the real world setting of acute cholecystitis. The purpose of this study is to demonstrate that a delayed laparoscopic cholecystectomy in a real world scenario has no worse outcome in comparison with an early operation (within 72 hours after onset of symptoms).
Detailed Description
Background: Randomized controlled trials (RCTs) and population based studies are in favor of an early operation in acute cholecystitis (1, 2). Thus, one of the largest RCT so far, demonstrated significant more complications in a group of delayed cholecystectomy. The main problems in these studies are the exclusion criteria used, ie severe cases are not considered. Objective: In a cohort study all cholecystectomy patients are analysed to demonstrate that delayed laparoscopic cholecystectomy (DLC) in a real world setting has a less complication rate than early cholecystectomy (ELC). Setting: Academic Teaching Hospital with 400 beds, seven departments (anesthesiology and intensive care medicine, orthopaedics and trauma surgery, visceral and thoracic surgery, gastroenterology, cardiology, gynecology and obstetrics, psychiatry. The visceral and thoracic department has a main focus on minimally invasive techniques. Participants: All cholecystectomy patients during 1/2006 and 9/2015 Variables: Clavien Dindo Complication score, American Society of Anaesthesiologist (ASA) Score, conversion rate, onset of symptoms, histology, hospital stay Data sources: Chart analyses
Study Type
Observational
Primary Outcome
Clavien-Dindo-Complication Score
Secondary Outcome
Conversion rate
Condition
Acute Cholecystitis
Intervention
Laparoscopic cholecystectomy (LC)
Study Arms / Comparison Groups
Early laparoscopic cholecystectomy (ELC)
Description: Operation within 72 hours after onset of symptoms
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
1729
Start Date
January 2006
Completion Date
May 2016
Primary Completion Date
September 2015
Eligibility Criteria
Inclusion Criteria: - All patients with cholecystectomies Exclusion Criteria: - No exclusion criteria
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Ernst W Hanisch, Prof Dr Dr, ,
Administrative Informations
NCT ID
NCT02796443
Organization ID
AKLangen
Responsible Party
Principal Investigator
Study Sponsor
Asklepios Klinik Langen
Collaborators
Goethe University
Study Sponsor
Ernst W Hanisch, Prof Dr Dr, Principal Investigator, Asklepios Klinik Langen
Verification Date
July 2019