An observational study in Acute Cholecystitis, sponsored by Asklepios Klinik Langen. Completed. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by Asklepios Klinik Langen · Observational
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).
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
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 1,729 is above the median of 200 across 90 observational studies indexed under Cholecystitis.
Browse Cholecystitis studies →This is the only study on the registry with Asklepios Klinik Langen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All cholecystectomized patients
Exclusion Criteria:
Operation within 72 hours after onset of symptoms
Procedure: Laparoscopic cholecystectomy (LC)
Operation within 14 days after onset of symptoms
Procedure: Laparoscopic cholecystectomy (LC)
Operation after 6-12 weeks
Procedure: Laparoscopic cholecystectomy (LC)
Biliary colic with no acute cholecystitis
Procedure: Laparoscopic cholecystectomy (LC)
Removal of the gallbladder via a minimally invasive approach
Clavien-Dindo-Complication Score
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.
Time frame: 3-6 days
Conversion rate
How often is the laparoscopic approach changed to the open procedure.
Time frame: Intraoperatively
No study locations are listed for this record.
Plan to share: Yes — Individual participant data (IPD) will be published on www.dkmic.de
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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