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Completed

NCT Number: NCT02796443

The Real World of Acute Cholecystitis

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).

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with cholecystectomies

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Laparoscopic cholecystectomy (LC)

Procedure

Removal of the gallbladder via a minimally invasive approach

Primary outcomes

  1. 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.

Secondary outcomes

  1. Conversion rate

    Time frame: Intraoperatively

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

Sponsors and collaborators

Lead sponsor

Asklepios Klinik Langen

Other

Collaborators

  • Goethe University

Registry information

Official study title

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

Acronym: REWO

Important dates

Study start
2006
Primary completion
2015
Study completion
2016
First posted
Jun 10, 2016
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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