NCT05257226

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress61%
Jan 2019Dec 2030

Study Start

First participant enrolled

January 1, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

6.1 years

First QC Date

February 1, 2022

Last Update Submit

February 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative short-term outcomes

    postoperative complications

    up to 24 weeks

Secondary Outcomes (1)

  • postoperative long-term outcomes

    5 year

Interventions

frailtyBEHAVIORAL

questionaire

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

surgically treated patients for gastroenterological diseases

You may qualify if:

  • surgical patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Takehiro Okabayashi

Kochi, 781-8555, Japan

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Takehiro Okabayashi

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Gastroenterological Surgery

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 25, 2022

Study Start

January 1, 2019

Primary Completion

January 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

February 25, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations