REWO: The Real World of Acute Cholecystitis
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Early laparoscopic cholecystectomy (ELC) Operation within 72 hours after onset of symptoms |
Procedure: Laparoscopic cholecystectomy (LC)
Removal of the gallbladder via a minimally invasive approach
|
Intermediate cholecystectomy (ILC) Operation within 14 days after onset of symptoms |
Procedure: Laparoscopic cholecystectomy (LC)
Removal of the gallbladder via a minimally invasive approach
|
Delayed LC (DLC) Operation after 6-12 weeks |
Procedure: Laparoscopic cholecystectomy (LC)
Removal of the gallbladder via a minimally invasive approach
|
Elective laparoscopic cholecystectomy Biliary colic with no acute cholecystitis |
Procedure: Laparoscopic cholecystectomy (LC)
Removal of the gallbladder via a minimally invasive approach
|
Outcome Measures
Primary Outcome Measures
- Clavien-Dindo-Complication Score [3-6 days]
During the hospital stay after Operation, which is usually between 3 and 6 days, all complications according to the Clavien-Dindo-Complication Score, are recorded.
Secondary Outcome Measures
- Conversion rate [Intraoperatively]
How often is the laparoscopic approach changed to the open procedure.
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients with cholecystectomies
Exclusion Criteria:
- No exclusion criteria
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Asklepios Klinik Langen
- University Hospital Frankfurt
Investigators
- Principal Investigator: Ernst W Hanisch, Prof Dr Dr, Asklepios Klinik Langen
Study Documents (Full-Text)
None provided.More Information
Publications
- de Mestral C, Rotstein OD, Laupacis A, Hoch JS, Zagorski B, Alali AS, Nathens AB. Comparative operative outcomes of early and delayed cholecystectomy for acute cholecystitis: a population-based propensity score analysis. Ann Surg. 2014 Jan;259(1):10-5. doi: 10.1097/SLA.0b013e3182a5cf36.
- Gutt CN, Encke J, Köninger J, Harnoss JC, Weigand K, Kipfmüller K, Schunter O, Götze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schön MR, Seitz HK, Daniel D, Stremmel W, Büchler MW. Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg. 2013 Sep;258(3):385-93. doi: 10.1097/SLA.0b013e3182a1599b.
- AKLangen