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Acute CholecystitisNCT06601855

Cholecystectomy Could be Performed in Older Adults With Acute Cholecystitis

An observational study of Acute Cholecystitis, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 80 years and olderHealthy volunteers can take part
Conditions the study is for
Acute Cholecystitis
What is being tested?
Cholecystectomy
Type of treatment
Surgery or procedure
How many people
160 participants
Where
1 siteTaiwan
Study dates
1 Sep 2018to 31 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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

Who may be able to join

  • Acute cholecystitis patients aged 80 years or older

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

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

    New Taipei City, 235041

Other trials in Taiwan

About this study

Official title: 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.

Read the detailed description

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

Being tested
Cholecystectomy
Keywords
acute cholecystitis, aged, cholecystectomy
Medical subject headings
Cholecystitis, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CholecystectomyProcedure or surgery

    Cholecystectomy, whether open or laparoscopic

Study groups in NCT06601855
Study groupRoleWhat they receive
Cholecystectomy groupPatient in this group received cholecystectomy, whether immediately, or delayed
Receives: Procedure: Cholecystectomy
Non-operative management groupPatients in this group did not receive cholecystectomy during follow up period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital mortality

    Expired during admission

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

  2. 30-day mortality

    Expired within 30 days since discharge

    Measured: 30 days since discharge

  3. Hospital return rate

    Rate of return to emergency room or readmission after discharge

    Measured: 18 months after discharge

Secondary outcomes (5)

  1. Hospital length of stay

    Period of hospitalization

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

  2. Intensive care unit length of stay

    How long has the person been admitted to the intensive care unit

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

  3. Intensive care unit admission frequency

    How many times have the person been admitted to the intensive care unit

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

  4. Outpatient department follow up frequency

    How many times has the person visited the outpatient department since discharge due to gallstone related disease or post cholecystectomy

    Measured: 18 months after discharge

  5. Outpatient department follow up duration

    Period of the last visit to the outpatient department due to gallstone related disease or post cholecystectomy, since discharge

    Measured: 18 months after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Sep 2018
  3. Primary completion30 Sep 2022
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06601855
Sponsor's protocol ID
jessie21211
Status last verified
Aug 2024
First submitted
15 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Escartin A, Gonzalez M, Cuello E, Pinillos A, Muriel P, Merichal M, Palacios V, Escoll J, Gas C, Olsina JJ. Acute Cholecystitis in Very Elderly Patients: Disease Management, Outcomes, and Risk Factors for Complications. Surg Res Pract. 2019 Feb 3;2019:9709242. doi: 10.1155/2019/9709242. eCollection 2019.

    PubMed 30854417

  • Asbun, Horacio & Shah, Mihir & Ceppa, Eugene & Auyang, Edward. (2020). The SAGES Manual of Biliary Surgery. 10.1007/978-3-030-13276-7

  • Yetkin G, Uludag M, Oba S, Citgez B, Paksoy I. Laparoscopic cholecystectomy in elderly patients. JSLS. 2009 Oct-Dec;13(4):587-91. doi: 10.4293/108680809X1258998404604.

    PubMed 20202402

  • Lee SJ, Choi IS, Moon JI, Yoon DS, Lee SE, Sung NS, Kwon SU, Bae IE, Roh SJ, Choi WJ. Elective Laparoscopic Cholecystectomy Is Better than Conservative Treatment in Elderly Patients with Acute Cholecystitis After Percutaneous Transhepatic Gallbladder Drainage. J Gastrointest Surg. 2021 Dec;25(12):3170-3177. doi: 10.1007/s11605-021-05067-1. Epub 2021 Jun 25.

    PubMed 34173163

  • Pisano M, Allievi N, Gurusamy K, Borzellino G, Cimbanassi S, Boerna D, Coccolini F, Tufo A, Di Martino M, Leung J, Sartelli M, Ceresoli M, Maier RV, Poiasina E, De Angelis N, Magnone S, Fugazzola P, Paolillo C, Coimbra R, Di Saverio S, De Simone B, Weber DG, Sakakushev BE, Lucianetti A, Kirkpatrick AW, Fraga GP, Wani I, Biffl WL, Chiara O, Abu-Zidan F, Moore EE, Leppaniemi A, Kluger Y, Catena F, Ansaloni L. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020 Nov 5;15(1):61. doi: 10.1186/s13017-020-00336-x.

    PubMed 33153472

  • Wiggins T, Markar SR, Mackenzie H, Jamel S, Askari A, Faiz O, Karamanakos S, Hanna GB. Evolution in the management of acute cholecystitis in the elderly: population-based cohort study. Surg Endosc. 2018 Oct;32(10):4078-4086. doi: 10.1007/s00464-018-6092-5. Epub 2018 Jul 25.

    PubMed 30046948

  • Lee CE, Lee SJ, Moon JI, Choi IS, Yoon DS, Choi WJ, Lee SE, Sung NS, Kwon SU, Bae IE, Roh SJ, Kim SG. Acute cholecystitis in old adults: the impact of advanced age on the clinical characteristics of the disease and on the surgical outcomes of laparoscopic cholecystectomy. BMC Gastroenterol. 2023 Sep 25;23(1):328. doi: 10.1186/s12876-023-02954-6.

    PubMed 37749524

  • Loozen CS, van Santvoort HC, van Duijvendijk P, Besselink MG, Gouma DJ, Nieuwenhuijzen GA, Kelder JC, Donkervoort SC, van Geloven AA, Kruyt PM, Roos D, Kortram K, Kornmann VN, Pronk A, van der Peet DL, Crolla RM, van Ramshorst B, Bollen TL, Boerma D. Laparoscopic cholecystectomy versus percutaneous catheter drainage for acute cholecystitis in high risk patients (CHOCOLATE): multicentre randomised clinical trial. BMJ. 2018 Oct 8;363:k3965. doi: 10.1136/bmj.k3965.

    PubMed 30297544

  • Ramirez-Giraldo C, Venegas-Sanabria LC, Rojas-Lopez S, Avendano-Morales V. Outcomes after laparoscopic cholecystectomy in patients older than 80 years: two-years follow-up. BMC Surg. 2024 Mar 12;24(1):87. doi: 10.1186/s12893-024-02383-6.

    PubMed 38475792

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Cholecystitis, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital mortality (time frame: From admission to discharge, average 8 days, minimal 2 days, maximal 51 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06601855, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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