The Real World of Acute Cholecystitis

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: September 2015

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

  • Procedure: Laparoscopic cholecystectomy (LC)
    • Removal of the gallbladder via a minimally invasive approach

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Clavien-Dindo-Complication Score
    • Time Frame: 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 Measures

  • Conversion rate
    • Time Frame: Intraoperatively
    • How often is the laparoscopic approach changed to the open procedure.

Participating in This Clinical Trial

Inclusion Criteria

  • All patients with cholecystectomies

Exclusion Criteria

  • No exclusion criteria

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asklepios Klinik Langen
  • Collaborator
    • University Hospital, Frankfurt
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. Dr. Ernst Hanisch, Prof. Dr. Dr. – Asklepios Klinik Langen
  • Overall Official(s)
    • Ernst W Hanisch, Prof Dr Dr, Principal Investigator, Asklepios Klinik Langen

References

Gutt CN, Encke J, Köninger J, Harnoss JC, Weigand K, Kipfmüller K, Schunter O, Götze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schön MR, Seitz HK, Daniel D, Stremmel W, Büchler MW. Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg. 2013 Sep;258(3):385-93. doi: 10.1097/SLA.0b013e3182a1599b.

de Mestral C, Rotstein OD, Laupacis A, Hoch JS, Zagorski B, Alali AS, Nathens AB. Comparative operative outcomes of early and delayed cholecystectomy for acute cholecystitis: a population-based propensity score analysis. Ann Surg. 2014 Jan;259(1):10-5. doi: 10.1097/SLA.0b013e3182a5cf36.

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