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The Real World of Acute Cholecystitis (REWO)

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ClinicalTrials.gov Identifier: NCT02796443
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
University Hospital, Frankfurt
Information provided by (Responsible Party):
Prof. Dr. Dr. Ernst Hanisch, Asklepios Klinik Langen

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
Acute Cholecystitis Procedure: Laparoscopic cholecystectomy (LC)

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


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Study Type : Observational
Actual Enrollment : 1729 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: When Results of Randomised Controlled Trials and Population Based Studies do Not Reflect the Real World: A Cohort Study in Acute Cholecystitis
Study Start Date : January 2006
Actual Primary Completion Date : September 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Conversion rate [ Time Frame: Intraoperatively ]
    How often is the laparoscopic approach changed to the open procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All cholecystectomized patients
Criteria

Inclusion Criteria:

  • All patients with cholecystectomies

Exclusion Criteria:

  • No exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796443


Sponsors and Collaborators
Asklepios Klinik Langen
University Hospital, Frankfurt
Investigators
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Principal Investigator: Ernst W Hanisch, Prof Dr Dr Asklepios Klinik Langen

Publications:
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Responsible Party: Prof. Dr. Dr. Ernst Hanisch, Prof. Dr. Dr., Asklepios Klinik Langen
ClinicalTrials.gov Identifier: NCT02796443     History of Changes
Other Study ID Numbers: AKLangen
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) will be published on www.dkmic.de

Keywords provided by Prof. Dr. Dr. Ernst Hanisch, Asklepios Klinik Langen:
acute cholecystitis
early versus delayed surgery

Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases