Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer (ROBO-G)

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

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;

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Colorectal Surgery; Geriatric Assessment
• Intervention / Treatment: Diagnostic test: Geriatric Assessment

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen Van Eetvelde, MD; Phone Number: +324775656; Email: ellen.vaneetvelde@uzbrussel.be
• Study Contact Backup: Name: Daniel Jacobs-Tulleneers-Thevissen, MD, PhD; Phone Number: +324775656; Email: daniel.jacobs-tulleneers-thevissen@uzbrussel.be

Study Locations

• Belgium
  • Brussels, Belgium
    • Recruiting
    • Universitair Ziekenhuis Brussel
    • Contact: Ellen Van Eetvelde, MD; Email: ellen.vaneetvelde@uzbrussel.be
  • Jette, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel
    • Contact: Ellen Van Eetvelde, MD; Email: ellen.vaneetvelde@uzbrussel.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Older patients with colorectal cancer; Patients undergo geriatric assessment including evaluation of cognitive function, functional status and quality of life	Diagnostic test: Geriatric Assessment; Geriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage (%) of patients demonstrating functional improvement at 3, 6 and 12 months after surgery	Percentage (%) of patients demonstrating functional decline/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	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	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	Number of patients where surgery can not be completed minimal invasive	during surgery
Length of hospital stay	Time patient spends in hospital	Immediate after surgery
Re-operation and re-admission rate	need for re-intervention or hospitalisation after discharge	< 30 days after surgery
Evolution of post-operative cognition	Mini-cog clock test followed by Mini Mental State Evaluation (MMSE) if abnormal	3, 6, 12 months post surgery
Postoperative confusion rate	CAM-analysis	7 days postoperative
30- day post-operative morbidity (Clavien-Dindo classification)	minor and major postoperative complications including anastomotic leakage	< 30 days postoperative
90- day post-operative mortality	number of patients that die after surgery	< 90 days postoperative
1-year patient survival	number of patients that are still alive one year after surgery	1 year postoperatively
1-year disease free survival	number of patients that do not show disease recurrence during the first postoperative year	1 year postoperatively
Comparison in outcome parameters between frail patients (abnormal screening) versus fit patients	Comparison in outcome parameters between frail patients (Groningen frailty indicator ≥ 4) versus fit patients (frailty indicator < 4)	up till 12 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathological analysis resection specimen	tumor stage, lymph node yield, resection quality	immediately after surgery
blood loss	estimated blood loss during surgery	during surgery

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Daniel Jacobs-Tulleneers-Thevissen, MD, PhD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: UZB-HLK: EVE-DJTT-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No