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NCT06213753 Clinical Trial

Complications of Non-Surgical Treatment in Acute Cholecystitis

Acute Cholecystitis Clinical Trial

Official title:
Complications of Non-Surgical Treatment in Acute Cholecystitis, the Unkonwn Pathway

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06213753
Other study ID # Complications of NST in ACC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2011
Est. completion date May 2022

Study information
Verified date January 2024
Source Hospital del Mar
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Acute cholecystitis (AC) is the second most frequent pathology in Surgical Emergencies; laparoscopic cholecystectomy (LC) is the gold standard treatment, but not all patients are fit for surgery. Percutaneous Cholecystostomy (PC) is an alternative to LC but has high comorbidity. There is no protocol in our institution for Non-Surgical Treatment (NST). This study aims to analyse the complications of non-surgical treatment and a new local management algorithm

Description:

It's a single-centre retrospective study of 1652 adults with AC from 2011 to 2022, including baseline demographic characteristics, comorbidity severity defined as the Charlson Comorbidity Index (CCI), ASA Score, and Tokyo Guidelines' severity classification. The primary outcome is to study the complications of NST.

Recruitment information / eligibility
Status Completed
Enrollment 1652
Est. completion date May 2022
Est. primary completion date January 2016
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnostic of an Acute Cholecystitis. - Older than 18 years old. Exclusion Criteria: - Younger than 18 years old.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital del Mar

Outcome
Type Measure Description Time frame Safety issue
Primary Complications The main outcome measure was the total of complications in patients with an Acute Calculous Cholecystitis assessed by the Clavien-Dindo Classification. 2011-2022
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