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The Real World of Acute Cholecystitis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02796443
Acronym
REWO
Enrollment
1729
Registered
2016-06-10
Start date
2006-01-31
Completion date
2016-05-31
Last updated
2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cholecystitis

Keywords

acute cholecystitis, early versus delayed surgery

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

Interventions

PROCEDURELaparoscopic cholecystectomy (LC)

Removal of the gallbladder via a minimally invasive approach

Sponsors

Goethe University
CollaboratorOTHER
Asklepios Klinik Langen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All patients with cholecystectomies

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Clavien-Dindo-Complication Score3-6 daysDuring 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

MeasureTime frameDescription
Conversion rateIntraoperativelyHow often is the laparoscopic approach changed to the open procedure.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026