The Real World of Acute Cholecystitis

Study Overview
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Brief Summary
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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
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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

Official Title
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When Results of Randomised Controlled Trials and Population Based Studies do Not Reflect the Real World: A Cohort Study in Acute Cholecystitis

Conditions
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Acute Cholecystitis

Intervention / Treatment
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* Procedure: Laparoscopic cholecystectomy (LC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with cholecystectomies Exclusion Criteria: No exclusion criteria
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early laparoscopic cholecystectomy (ELC)<br>Operation within 72 hours after onset of symptoms | Procedure: Laparoscopic cholecystectomy (LC)<br>* Removal of the gallbladder via a minimally invasive approach<br>|
| Intermediate cholecystectomy (ILC)<br>Operation within 14 days after onset of symptoms | Procedure: Laparoscopic cholecystectomy (LC)<br>* Removal of the gallbladder via a minimally invasive approach<br>|
| Delayed LC (DLC)<br>Operation after 6-12 weeks | Procedure: Laparoscopic cholecystectomy (LC)<br>* Removal of the gallbladder via a minimally invasive approach<br>|
| Elective laparoscopic cholecystectomy<br>Biliary colic with no acute cholecystitis | Procedure: Laparoscopic cholecystectomy (LC)<br>* Removal of the gallbladder via a minimally invasive approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clavien-Dindo-Complication Score | 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. | 3-6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion rate | How often is the laparoscopic approach changed to the open procedure. | Intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute cholecystitis, early versus delayed surgery