NCT05848609

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;

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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 Progress83%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

September 19, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 8, 2023

Status Verified

April 1, 2023

Enrollment Period

3.8 years

First QC Date

September 19, 2022

Last Update Submit

April 28, 2023

Conditions

Colorectal SurgeryGeriatric AssessmentQuality of Life

Outcome Measures

Primary Outcomes (3)

  • Change in frailty status G8 status

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

    Before and 3-6-12 months after surgery

  • Change in frailty status GFI status

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

    Before and 3-6-12 months after surgery

  • Change in Quality of Life

    Measurement of QoL using validated EORTC QoL questionnaire

    Before and 3-6-12 months after surgery

Secondary Outcomes (13)

  • 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

  • Percentage of patients demonstrating a significant decrease/improvement of QoL at 3,6,12 months after surgery

    3-6-12 months after surgery

  • Conversion-rate to open surgery

    during surgery

  • Length of hospital stay

    Immediate after surgery

  • +8 more secondary outcomes

Other Outcomes (2)

  • pathological analysis resection specimen

    immediately after surgery

  • blood loss

    during surgery

Study Arms (1)

Older patients with colorectal cancer

OTHER

Patients undergo geriatric assessment including evaluation of cognitive function, functional status and quality of life

Diagnostic Test: Geriatric Assessment

Interventions

Geriatric AssessmentDIAGNOSTIC_TEST

Geriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery

Older patients with colorectal cancer

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitair Ziekenhuis Brussel

Brussels, Belgium

RECRUITING

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

RECRUITING

Study Officials

  • Daniel Jacobs-Tulleneers-Thevissen, MD, PhD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen Van Eetvelde, MD

CONTACT

+324775656ellen.vaneetvelde@uzbrussel.be

Daniel Jacobs-Tulleneers-Thevissen, MD, PhD

CONTACT

+324775656daniel.jacobs-tulleneers-thevissen@uzbrussel.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2022

First Posted

May 8, 2023

Study Start

March 15, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 8, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)