Both Short- and Long-term Outcome Differences According to Patient Frailty

Sponsor
Kochi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05257226
Collaborator
(none)
1,000
1
144
6.9

Study Details

Study Description

Brief Summary

The evaluation for cancer treatment successful has been used by overall survival rate and/or postoperative complications, especially surgical area. Now postoperative QOL has been more importantly required. Therefore this study was conduced to investigate the association between postoperative outcomes and patients frailty.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: frailty

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Both Short- and Long-term Outcome Differences According to Patient Frailty
Actual Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jan 31, 2025
Anticipated Study Completion Date :
Dec 31, 2030

Outcome Measures

Primary Outcome Measures

  1. postoperative short-term outcomes [up to 24 weeks]

    postoperative complications

Secondary Outcome Measures

  1. postoperative long-term outcomes [5 year]

    survival rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • surgical patients
Exclusion Criteria:
  • a body weight loss of >10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Takehiro Okabayashi Kochi Japan 781-8555

Sponsors and Collaborators

  • Kochi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Takehiro Okabayashi, Department of Gastroenterological Surgery, Kochi University
ClinicalTrials.gov Identifier:
NCT05257226
Other Study ID Numbers:
  • Bos study
First Posted:
Feb 25, 2022
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2022