Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer
- Conditions
- Geriatric AssessmentQuality of LifeColorectal Surgery
- Interventions
- Diagnostic Test: Geriatric Assessment
- Registration Number
- NCT05848609
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- 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;
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- patients ≥ 70 years with colorectal cancer
- eligible for colorectal surgery after multidisciplinary board evaluation and patient consent
- decline in cognitive function after geriatric evaluation
- emergency surgery
- life expectancy < 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Older patients with colorectal cancer Geriatric Assessment Patients undergo geriatric assessment including evaluation of cognitive function, functional status and quality of life
- Primary Outcome Measures
Name Time Method Change in Quality of Life Before and 3-6-12 months after surgery Measurement of QoL using validated EORTC QoL questionnaire
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)
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)
- Secondary Outcome Measures
Name Time Method Re-operation and re-admission rate < 30 days after surgery need for re-intervention or hospitalisation after discharge
1-year disease free survival 1 year postoperatively number of patients that do not show disease recurrence during the first postoperative year
Length of hospital stay Immediate after surgery Time patient spends in hospital
30- day post-operative morbidity (Clavien-Dindo classification) < 30 days postoperative minor and major postoperative complications including anastomotic leakage
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
Evolution of post-operative cognition 3, 6, 12 months post surgery Mini-cog clock test followed by Mini Mental State Evaluation (MMSE) if abnormal
Postoperative confusion rate 7 days postoperative CAM-analysis
1-year patient survival 1 year postoperatively number of patients that are still alive one year after surgery
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)
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
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
Conversion-rate to open surgery during surgery Number of patients where surgery can not be completed minimal invasive
90- day post-operative mortality < 90 days postoperative number of patients that die after surgery
Trial Locations
- Locations (1)
Universitair Ziekenhuis Brussel
🇧🇪Jette, Belgium