The Real World of Acute Cholecystitis

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Cholecystitis
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Brief Title

The Real World of Acute Cholecystitis

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 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

Primary Outcome

Clavien-Dindo-Complication Score

Secondary Outcome

 Conversion rate

Condition

Acute Cholecystitis

Intervention

Laparoscopic cholecystectomy (LC)

Study Arms / Comparison Groups

 Early laparoscopic cholecystectomy (ELC)
Description:  Operation within 72 hours after onset of symptoms

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

1729

Start Date

January 2006

Completion Date

May 2016

Primary Completion Date

September 2015

Eligibility Criteria

        Inclusion Criteria:

          -  All patients with cholecystectomies

        Exclusion Criteria:

          -  No exclusion criteria

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Ernst W Hanisch, Prof Dr Dr, ,

Administrative Informations

NCT ID

NCT02796443

Organization ID

AKLangen

Responsible Party

Principal Investigator

Study Sponsor

Asklepios Klinik Langen

Collaborators

 Goethe University

Study Sponsor

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

Verification Date

July 2019