Clinical trial NCT06601855: Cholecystectomy Could be Performed in Older Adults With Acute Cholecystitis
Official title: Cholecystectomy Could be Performed in Adults Older Than 80 Years Old With Mild to Moderate Acute Cholecystitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis
Keywords: acute cholecystitis
aged
cholecystectomy
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 160
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-hospital mortality
timeFrame: From admission to discharge, average 8 days, minimal 2 days, maximal 51 days
measure: 30-day mortality
timeFrame: 30 days since discharge
measure: Hospital return rate
timeFrame: 18 months after discharge
Secondary outcomes:
measure: Hospital length of stay
timeFrame: From admission to discharge, average 8 days, minimal 2 days, maximal 51 days
measure: Intensive care unit length of stay
timeFrame: From admission to discharge, average 8 days, minimal 2 days, maximal 51 days
measure: Intensive care unit admission frequency
timeFrame: From admission to discharge, average 8 days, minimal 2 days, maximal 51 days
measure: Outpatient department follow up frequency
timeFrame: 18 months after discharge
measure: Outpatient department follow up duration
timeFrame: 18 months after discharge
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
Study officials:
affiliation: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
name: Chieh-Ju Liao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
name: Kuei-Yen Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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