NCT06704646

Brief Summary

The aim of this study is to determine which preoperative factors are associated with one-year postoperative mortality in patients aged ≥80 years undergoing curative surgery and compare outcomes between patients with or without risk factors.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
Last Updated

November 27, 2024

Status Verified

December 1, 2020

Enrollment Period

7 years

First QC Date

November 21, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

Colorectal cancerGeriatrics

Outcome Measures

Primary Outcomes (1)

  • Preoperative factors associated with one-year postoperative mortality

    Univariate and multivariable logistic regression analysis were performed to identify preoperative factors associated with one-year postoperative mortality.

    From operation to one year after the surgery

Study Arms (2)

Patients passed away within one year

Records their age, gender, preoperative comorbidities, and calculated their Charlson comorbidity index. We also collected information on tumor location, serum levels of carcinoembryonic antigen (CEA), preoperative clinical TNM staging, and postoperative pathological TNM staging

Procedure: Curative intent surgery

Patient survived the first post-operative year

Records their age, gender, preoperative comorbidities, and calculated their Charlson comorbidity index. We also collected information on tumor location, serum levels of carcinoembryonic antigen (CEA), preoperative clinical TNM staging, and postoperative pathological TNM staging

Procedure: Curative intent surgery

Interventions

Curative intent surgery means that surgeons intend to perform R0 resection.

Patient survived the first post-operative yearPatients passed away within one year

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective study was performed at National Taiwan University hospital. Patients aged ≥80 years with stages I-III colorectal cancer who underwent tumor resection from January 2014 to January 2019, and they were followed up until December 31, 2020. Patients undergoing procedure without colectomy, or tumor excised by transanal method were excluded from this study.

You may qualify if:

  • Patients aged ≥80 years with stages I-III colorectal cancer who underwent tumor resection from January 2014 to January 2019

You may not qualify if:

  • Patients undergoing procedure without colectomy, or tumor excised by transanal method were excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Keum N, Giovannucci E. Global burden of colorectal cancer: emerging trends, risk factors and prevention strategies. Nat Rev Gastroenterol Hepatol. 2019 Dec;16(12):713-732. doi: 10.1038/s41575-019-0189-8. Epub 2019 Aug 27.

    PMID: 31455888BACKGROUND
  • Chen B, Yu W, Ma Y, Xu P, Yao Q, Sun Q, Ren J, Wang D. Evaluation of the safety and efficacy of perform enterectomy in colorectal cancer patients aged 80 or older. A meta-analysis and a systematic review. Int J Colorectal Dis. 2023 Jul 3;38(1):185. doi: 10.1007/s00384-023-04461-2.

    PMID: 37395836BACKGROUND
  • Dekker JW, van den Broek CB, Bastiaannet E, van de Geest LG, Tollenaar RA, Liefers GJ. Importance of the first postoperative year in the prognosis of elderly colorectal cancer patients. Ann Surg Oncol. 2011 Jun;18(6):1533-9. doi: 10.1245/s10434-011-1671-x. Epub 2011 Mar 29.

    PMID: 21445672BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

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

Study Record Dates

First Submitted

November 21, 2024

First Posted

November 26, 2024

Study Start

January 1, 2014

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 27, 2024

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share