The Real World of Acute Cholecystitis

NCT02796443 | Completed

• 1 other identifier: AKLangen
• Study Type: observational
• Target: 1,729
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Acute Cholecystitis

Keywords

acute cholecystitis; early versus delayed surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  3-6 days

Secondary Outcomes (1)

• Conversion rate

  Intraoperatively

Study Arms (4)

Early laparoscopic cholecystectomy (ELC)

Operation within 72 hours after onset of symptoms

Procedure: Laparoscopic cholecystectomy (LC)

Intermediate cholecystectomy (ILC)

Operation within 14 days after onset of symptoms

Procedure: Laparoscopic cholecystectomy (LC)

Delayed LC (DLC)

Operation after 6-12 weeks

Procedure: Laparoscopic cholecystectomy (LC)

Elective laparoscopic cholecystectomy

Biliary colic with no acute cholecystitis

Procedure: Laparoscopic cholecystectomy (LC)

Interventions

Laparoscopic cholecystectomy (LC) PROCEDURE

Removal of the gallbladder via a minimally invasive approach

Delayed LC (DLC); Early laparoscopic cholecystectomy (ELC); Elective laparoscopic cholecystectomy; Intermediate cholecystectomy (ILC)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All cholecystectomized patients

You may qualify if:

• All patients with cholecystectomies

Sponsors & Collaborators

• Asklepios Klinik Langen: lead
• Goethe University: collaborator

Related Publications (2)

• Gutt CN, Encke J, Koninger J, Harnoss JC, Weigand K, Kipfmuller K, Schunter O, Gotze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schon MR, Seitz HK, Daniel D, Stremmel W, Buchler 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.

  PMID: 24022431 BACKGROUND

• 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.

  PMID: 23979286 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Ernst W Hanisch, Prof Dr Dr

  Asklepios Klinik Langen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 10, 2016
• Study Start: January 1, 2006
• Primary Completion: September 1, 2015
• Study Completion: May 1, 2016
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share