Cholecystectomy Could be Performed in Older Adults With Acute Cholecystitis

September 17, 2024 updated by: Taipei Medical University Shuang Ho Hospital

Cholecystectomy Could be Performed in Adults Older Than 80 Years Old With Mild to Moderate Acute Cholecystitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 235041
        • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with mild to moderate (grade I and grade II) acute cholecystitis, who were 80 years old or older, were included.

Description

Inclusion Criteria:

  • Acute cholecystitis patients aged 80 years or older

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cholecystectomy group
Patient in this group received cholecystectomy, whether immediately, or delayed
Procedure: Cholecystectomy
Cholecystectomy, whether open or laparoscopic
Non-operative management group
Patients in this group did not receive cholecystectomy during follow up period

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Principal Investigator: Chieh-Ju Liao, MD, Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
  • Principal Investigator: Kuei-Yen Tsai, PhD, Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

September 15, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • jessie21211

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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