Cholecystectomy Could be Performed in Older Adults With Acute Cholecystitis

Completed

• Conditions: Acute Cholecystitis
• Interventions: Procedure: Cholecystectomy

• Registration Number: NCT06601855
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

Brief Summary

The goal of this retrospective cohort observational study is to learn about the long-term and short-term effects of cholecystectomy in people aged 80 or over the age of 80, who have mild to moderate acute cholecystitis. The main question it aims to answer is:

Does cholecystectomy bring harm or benefit to people aged 80, or over the age of 80, who have mild to moderate acute cholecystitis? People who received cholecystectomy are compared to those who did not, for short- and long-term outcomes, with a follow up period for 18 months.

Detailed Description

All data were collected from Shuang-Ho Hospital electronic medical record.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2022-09-30
• Study Completion: 2024-03-31
• Status Verified: 2024-08
• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Acute cholecystitis patients aged 80 years or older

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Exclusion Criteria

• Grade III acute cholecystitis
• Concurrent cholangitis, common bile duct stones, pancreatitis, gallbladder cancer, hepatocellular carcinoma, periampullary cancer
• Received other operations at the same admission other than cholecystectomy
• Discharged against advice of physician
• Received further management at another hospital for acute cholecystitis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cholecystectomy group	Cholecystectomy	Patient in this group received cholecystectomy, whether immediately, or delayed

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	From admission to discharge, average 8 days, minimal 2 days, maximal 51 days	Expired during admission
30-day mortality	30 days since discharge	Expired within 30 days since discharge
Hospital return rate	18 months after discharge	Rate of return to emergency room or readmission after discharge

Secondary Outcome Measures

Name	Time	Method
Intensive care unit length of stay	From admission to discharge, average 8 days, minimal 2 days, maximal 51 days	How long has the person been admitted to the intensive care unit
Hospital length of stay	From admission to discharge, average 8 days, minimal 2 days, maximal 51 days	Period of hospitalization
Intensive care unit admission frequency	From admission to discharge, average 8 days, minimal 2 days, maximal 51 days	How many times have the person been admitted to the intensive care unit
Outpatient department follow up frequency	18 months after discharge	How many times has the person visited the outpatient department since discharge due to gallstone related disease or post cholecystectomy
Outpatient department follow up duration	18 months after discharge	Period of the last visit to the outpatient department due to gallstone related disease or post cholecystectomy, since discharge

Trial Locations

Locations (1)

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare; 🇨🇳 New Taipei City, Taiwan