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

Study Overview
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Brief Summary
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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;

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

Conditions
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Colorectal Surgery, Geriatric Assessment, Quality of Life

Intervention / Treatment
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* Diagnostic Test: Geriatric Assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |