Cholecystectomy Could be Performed in Older Adults With Acute Cholecystitis

NCT06601855 | Completed

• 1 other identifier: jessie21211
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis

Keywords

acute cholecystitis; aged; cholecystectomy

Outcome Measures

Primary Outcomes (3)

• In-hospital mortality

  Expired during admission

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

• 30-day mortality

  Expired within 30 days since discharge

  30 days since discharge

• Hospital return rate

  Rate of return to emergency room or readmission after discharge

  18 months after discharge

Secondary Outcomes (5)

• Hospital length of stay

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

• Intensive care unit length of stay

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

• Intensive care unit admission frequency

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

• Outpatient department follow up frequency

  18 months after discharge

• Outpatient department follow up duration

  18 months after discharge

Study Arms (2)

Cholecystectomy group

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

Procedure: Cholecystectomy

Non-operative management group

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

Interventions

Cholecystectomy PROCEDURE

Cholecystectomy, whether open or laparoscopic

Cholecystectomy group

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Acute cholecystitis patients aged 80 years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

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

New Taipei City, 235041, Taiwan

Location

Related Publications (9)

• 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.

  PMID: 30854417 BACKGROUND

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

  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.

  PMID: 20202402 BACKGROUND

• 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.

  PMID: 34173163 BACKGROUND

• 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.

  PMID: 33153472 RESULT

• 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.

  PMID: 30046948 RESULT

• 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.

  PMID: 37749524 RESULT

• 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.

  PMID: 30297544 RESULT

• 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.

  PMID: 38475792 RESULT

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2018
• Primary Completion: September 30, 2022
• Study Completion: March 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)