Cholecystectomy Could be Performed in Older Adults With Acute Cholecystitis

NCT ID: NCT06601855

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2024-03-31

Brief Summary

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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

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

Conditions

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Acute Cholecystitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cholecystectomy group

Patient in this group received cholecystectomy, whether immediately, or delayed

Cholecystectomy

Intervention Type PROCEDURE

Cholecystectomy, whether open or laparoscopic

Non-operative management group

Patients in this group did not receive cholecystectomy during follow up period

No interventions assigned to this group

Interventions

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Cholecystectomy

Cholecystectomy, whether open or laparoscopic

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chieh-Ju Liao, MD

Role: PRINCIPAL_INVESTIGATOR

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

Kuei-Yen Tsai, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 30854417 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 20202402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34173163 (View on PubMed)

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.

Reference Type RESULT
PMID: 33153472 (View on PubMed)

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.

Reference Type RESULT
PMID: 30046948 (View on PubMed)

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.

Reference Type RESULT
PMID: 37749524 (View on PubMed)

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.

Reference Type RESULT
PMID: 30297544 (View on PubMed)

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.

Reference Type RESULT
PMID: 38475792 (View on PubMed)

Other Identifiers

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jessie21211

Identifier Type: -

Identifier Source: org_study_id

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