The Real World of Acute Cholecystitis

Completed

• Conditions: Acute Cholecystitis
• Interventions: Procedure: Laparoscopic cholecystectomy (LC)

• Registration Number: NCT02796443
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2006-01
• Primary Completion: 2015-09
• Study Completion: 2016-05
• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1729

Inclusion Criteria

• All patients with cholecystectomies

Exclusion Criteria

• No exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clavien-Dindo-Complication Score	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

Name	Time	Method
Conversion rate	Intraoperatively	How often is the laparoscopic approach changed to the open procedure.