CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,729 enrolled
Drug / intervention
Laparoscopic cholecystectomy (LC)procedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02796443
NCT02796443N/ACompleted
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When Results of Randomised Controlled Trials and Population Based Studies do Not Reflect the Real World: A Cohort Study in Acute Cholecystitis

Asklepios Klinik Langen·observational·Posted Jun 10, 2016·Updated Jul 26, 2019

In Brief

An observational study evaluating Laparoscopic cholecystectomy (LC) for Acute Cholecystitis. Completed, enrolled 1,729 participants.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Cholecystitis
Countries--
CollaboratorsGoethe University

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 10, 2016
Enrollment StartJan 1, 2006
Primary CompletionSep 1, 2015
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 10.1 years ago

Interventions

Laparoscopic cholecystectomy (LC)procedure

Removal of the gallbladder via a minimally invasive approach