Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer

Quality of Life Clinical Trial

— ROBO-G  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848609
• Other study ID #: UZB-HLK: EVE-DJTT-002
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Ellen Van Eetvelde, MD
• Phone: +324775656
• Email: ellen.vaneetvelde[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery
• Geriatric Assessment
• Quality of Life

Intervention

Diagnostic Test:
• Geriatric Assessment
Geriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels
Belgium	Universitair Ziekenhuis Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pathological analysis resection specimen	tumor stage, lymph node yield, resection quality	immediately after surgery
Other	blood loss	estimated blood loss during surgery	during surgery
Primary	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
Primary	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
Primary	Change in Quality of Life	Measurement of QoL using validated EORTC QoL questionnaire	Before and 3-6-12 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Conversion-rate to open surgery	Number of patients where surgery can not be completed minimal invasive	during surgery
Secondary	Length of hospital stay	Time patient spends in hospital	Immediate after surgery
Secondary	Re-operation and re-admission rate	need for re-intervention or hospitalisation after discharge	< 30 days after surgery
Secondary	Evolution of post-operative cognition	Mini-cog clock test followed by Mini Mental State Evaluation (MMSE) if abnormal	3, 6, 12 months post surgery
Secondary	Postoperative confusion rate	CAM-analysis	7 days postoperative
Secondary	30- day post-operative morbidity (Clavien-Dindo classification)	minor and major postoperative complications including anastomotic leakage	< 30 days postoperative
Secondary	90- day post-operative mortality	number of patients that die after surgery	< 90 days postoperative
Secondary	1-year patient survival	number of patients that are still alive one year after surgery	1 year postoperatively
Secondary	1-year disease free survival	number of patients that do not show disease recurrence during the first postoperative year	1 year postoperatively
Secondary	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