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

• Sponsor: Universitair Ziekenhuis Brussel (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05848609
• Collaborator: (none)
• Enrollment: 120
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 45.6
• Patients Per Site: 60
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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;

Condition or Disease	Intervention/Treatment	Phase
Colorectal Surgery; Geriatric Assessment; Quality of Life	Diagnostic Test: Geriatric Assessment	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Prospective Evaluation of Functional Status and Quality of Life in Older Patients With Colorectal Cancer Undergoing Robotic Surgery
• Actual Study Start Date: Mar 15, 2023
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in frailty status G8 status [Before and 3-6-12 months after surgery]

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

2. Change in frailty status GFI status [Before and 3-6-12 months after surgery]

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

3. Change in Quality of Life [Before and 3-6-12 months after surgery]

   Measurement of QoL using validated EORTC QoL questionnaire

Secondary Outcome Measures

1. 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 decline/improvement at 3, 6 and 12 months after surgery

2. 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 functional recovery at 12 months after initial func-tional decline after surgery

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

4. Conversion-rate to open surgery [during surgery]

   Number of patients where surgery can not be completed minimal invasive

5. Length of hospital stay [Immediate after surgery]

   Time patient spends in hospital

6. Re-operation and re-admission rate [< 30 days after surgery]

   need for re-intervention or hospitalisation after discharge

7. Evolution of post-operative cognition [3, 6, 12 months post surgery]

   Mini-cog clock test followed by Mini Mental State Evaluation (MMSE) if abnormal

8. Postoperative confusion rate [7 days postoperative]

   CAM-analysis

9. 30- day post-operative morbidity (Clavien-Dindo classification) [< 30 days postoperative]

   minor and major postoperative complications including anastomotic leakage

10. 90- day post-operative mortality [< 90 days postoperative]

    number of patients that die after surgery

11. 1-year patient survival [1 year postoperatively]

    number of patients that are still alive one year after surgery

12. 1-year disease free survival [1 year postoperatively]

    number of patients that do not show disease recurrence during the first postoperative year

13. Comparison in outcome parameters between frail patients (abnormal screening) versus fit patients [up till 12 months postoperatively]

    Comparison in outcome parameters between frail patients (Groningen frailty indicator ≥ 4) versus fit patients (frailty indicator < 4)

Other Outcome Measures

1. pathological analysis resection specimen [immediately after surgery]

   tumor stage, lymph node yield, resection quality

2. blood loss [during surgery]

   estimated blood loss during surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Brussel	Brussels		Belgium
2	Universitair Ziekenhuis Brussel	Jette		Belgium	1090

Sponsors and Collaborators

• Universitair Ziekenhuis Brussel

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitair Ziekenhuis Brussel
• ClinicalTrials.gov Identifier: NCT05848609
• Other Study ID Numbers: UZB-HLK: EVE-DJTT-002
• First Posted: May 8, 2023
• Last Update Posted: May 8, 2023
• Last Verified: Apr 1, 2023

• 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

Study Results

No Results Posted as of May 8, 2023