Complications of Cholecystostomy in ACC

Not yet recruiting

• Conditions: Cholecystitis

• Registration Number: NCT06227936
• Lead Sponsor: Hospital del Mar

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-12
• Study Start: 2024-05-15
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	2011-2023	The second main outcome measure is the mortality in patients with an Acute Cholecystitis and its cause.
Complications	2011-2023	The main outcome measure is the complications due to the PC treatment.

Secondary Outcome Measures

Name	Time	Method
Types of cholecystostomy	2011-2023	There are different indications for cholecystostomy. To do a description of them.
Surgical Rescue	2011-2023	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.