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Completed

NCT Number: NCT06601855

Cholecystectomy Could be Performed in Older Adults With 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.

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, 235041, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecystectomy

Procedure

Cholecystectomy, whether open or laparoscopic

Primary outcomes

  1. In-hospital mortality

    Time frame: From admission to discharge, average 8 days, minimal 2 days, maximal 51 days

    Expired during admission

  2. 30-day mortality

    Time frame: 30 days since discharge

    Expired within 30 days since discharge

  3. Hospital return rate

    Time frame: 18 months after discharge

    Rate of return to emergency room or readmission after discharge

Secondary outcomes

  1. Hospital length of stay

    Time frame: From admission to discharge, average 8 days, minimal 2 days, maximal 51 days

    Period of hospitalization

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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