ClinicalTrials.Veeva

Menu

The Real World of Acute Cholecystitis (REWO)

A

Asklepios Klinik Langen

Status

Completed

Conditions

Acute Cholecystitis

Treatments

Procedure: Laparoscopic cholecystectomy (LC)

Study type

Observational

Funder types

Other

Identifiers

NCT02796443
AKLangen

Details and patient eligibility

About

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).

Full 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

Enrollment

1,729 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients with cholecystectomies

Exclusion criteria

  • No exclusion criteria

Trial design

1,729 participants in 4 patient groups

Early laparoscopic cholecystectomy (ELC)
Description:
Operation within 72 hours after onset of symptoms
Treatment:
Procedure: Laparoscopic cholecystectomy (LC)
Intermediate cholecystectomy (ILC)
Description:
Operation within 14 days after onset of symptoms
Treatment:
Procedure: Laparoscopic cholecystectomy (LC)
Delayed LC (DLC)
Description:
Operation after 6-12 weeks
Treatment:
Procedure: Laparoscopic cholecystectomy (LC)
Elective laparoscopic cholecystectomy
Description:
Biliary colic with no acute cholecystitis
Treatment:
Procedure: Laparoscopic cholecystectomy (LC)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems