Clinical Trial: The Real World of Acute Cholecystitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Summary:

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


Sponsor: Asklepios Klinik Langen

Current Primary Outcome: Clavien-Dindo-Complication Score [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Conversion rate [ Time Frame: Intraoperatively ]

How often is the laparoscopic approach changed to the open procedure.


Original Secondary Outcome: Same as current

Information By: Asklepios Klinik Langen

Dates:
Date Received: June 1, 2016
Date Started: January 2006
Date Completion:
Last Updated: June 14, 2016
Last Verified: June 2016