The Real World of Acute Cholecystitis (REWO)

July 24, 2019 updated by: Prof. Dr. Dr. Ernst Hanisch, Asklepios Klinik Langen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All cholecystectomized patients

Description

Inclusion Criteria:

  • All patients with cholecystectomies

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3-6 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios Klinik Langen

Collaborators

University Hospital Frankfurt

Investigators

  • Principal Investigator: Ernst W Hanisch, Prof Dr Dr, Asklepios Klinik Langen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (ESTIMATE)

June 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKLangen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) will be published on www.dkmic.de

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Cholecystitis

Clinical Trials on Laparoscopic cholecystectomy (LC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe