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
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cholecystitis

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