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NCT06227936 Clinical Trial

Complications of Cholecystostomy in ACC

Cholecystitis Clinical Trial

— Chole_ACC  

Official title:
Percutaneous Cholecystostomy, Old-fashioned or There is There Still a Role in ACC?

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06227936
Other study ID # Cholecystostomy in ACC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 15, 2024
Est. completion date September 30, 2024

Study information
Verified date March 2024
Source Hospital del Mar
Contact Ana María González Castillo, PhD
Phone +34665126866
Email amgonzalezcastillo@gmail.com
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 at the diagnostic. Percutaneous Cholecystostomy (PC) is an alternative to LC but has high comorbidity. This study aims to analyse the complications of PC and review its indications in the literature.

Description:

It is a single-centre retrospective study of 2000 acute cholecystitis in adults from January 2011 to december 2023, including demographyc characteristics, comorbidy severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines severity classification,the indicatioons for a PC and local complications of PC.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 2000
Est. completion date September 30, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients admited in the Hospital del Mar with the diagnostic of an Acute Cholecystitis Exclusion Criteria: - Acute cholangitis - Acute Pancreatitis - Neoplasia - Chronic Cholecystitis - Patients under 18 yearls old - Pregnancy

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 is the complications due to the PC treatment. 2011-2023
Primary Mortality The second main outcome measure is the mortality in patients with an Acute Cholecystitis and its cause. 2011-2023
Secondary Types of cholecystostomy There are different indications for cholecystostomy. To do a description of them. 2011-2023
Secondary Surgical Rescue To study the patients that needed a surgical treatment and those who could be operated after recovery from sepsis and descrive the outcomes of all of them within the Clavien-Dindo Classification. 2011-2023
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