Complications of Non-Surgical Treatment in Acute Cholecystitis

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

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

Study Overview

• Status: Completed
• Conditions: Acute Cholecystitis

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1652

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients admited with the diagnostic of Acute Cholecystitis

Description

Inclusion Criteria:

• Diagnostic of an Acute Cholecystitis.
• Older than 18 years old.

Exclusion Criteria:

• Younger than 18 years old.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital del Mar

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Mortality; Cholecystectomy; Acute Cholecystitis; Tokyo Guidelines; Non-Surgical Treatment; High-risk patient
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: Complications of NST in ACC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No