Prospective Evaluation of Functional Status and Quality of Life in Older Patients With Colorectal Cancer Undergoing Robotic Surgery

Universitair Ziekenhuis Brussel1 site in 1 country120 target enrollmentMarch 15, 2023

ConditionsColorectal Surgery Geriatric Assessment Quality of Life

Overview

Phase: N/A
Intervention: Not specified
Conditions: Colorectal Surgery
Sponsor: Universitair Ziekenhuis Brussel
Enrollment: 120
Locations: 1
Primary Endpoint: Change in frailty status GFI status
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study evaluates prospectively the impact of robotic surgery on functional outcome and quality of life in older patients that are operated for colorectal cancer;

Registry

clinicaltrials.gov

Start Date

March 15, 2023

End Date

December 31, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Universitair Ziekenhuis Brussel

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•patients ≥ 70 years with colorectal cancer
•eligible for colorectal surgery after multidisciplinary board evaluation and patient consent

Exclusion Criteria

•decline in cognitive function after geriatric evaluation
•emergency surgery
•life expectancy \< 3 months

Outcomes

Primary Outcomes

Change in frailty status GFI status

Time Frame: Before and 3-6-12 months after surgery

Measurement of functional status using the Groningen Frailty Indicator (GFI) Screening Tool (fTRST)

Change in Quality of Life

Time Frame: Before and 3-6-12 months after surgery

Measurement of QoL using validated EORTC QoL questionnaire

Change in frailty status G8 status

Time Frame: Before and 3-6-12 months after surgery

Measurement of functional status using the G8, Flemish version of the Triage Risk Screening Tool (fTRST)

Secondary Outcomes

Re-operation and re-admission rate(< 30 days after surgery)
1-year disease free survival(1 year postoperatively)
Postoperative confusion rate(7 days postoperative)
Length of hospital stay(Immediate after surgery)
30- day post-operative morbidity (Clavien-Dindo classification)(< 30 days postoperative)
Percentage of patients demonstrating a significant decrease/improvement of QoL at 3,6,12 months after surgery(3-6-12 months after surgery)
Evolution of post-operative cognition(3, 6, 12 months post surgery)
1-year patient survival(1 year postoperatively)
Comparison in outcome parameters between frail patients (abnormal screening) versus fit patients(up till 12 months postoperatively)
Conversion-rate to open surgery(during surgery)
Percentage (%) of patients demonstrating functional improvement at 3, 6 and 12 months after surgery(3-6-12 months after surgery)
Percentage of patients demonstrating functional recovery at 12 months after initial func-tional decline after surgery(3-6-12 months after surgery)
90- day post-operative mortality(< 90 days postoperative)