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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
120
Geriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery
Universitair Ziekenhuis Brussel
Brussels, Belgium
RECRUITINGUniversitair Ziekenhuis Brussel
Jette, Belgium
RECRUITINGChange in frailty status G8 status
Measurement of functional status using the G8, Flemish version of the Triage Risk Screening Tool (fTRST)
Time frame: 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)
Time frame: Before and 3-6-12 months after surgery
Change in Quality of Life
Measurement of QoL using validated EORTC QoL questionnaire
Time frame: Before and 3-6-12 months after surgery
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
Time frame: 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
Time frame: 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
Time frame: 3-6-12 months after surgery
Conversion-rate to open surgery
Number of patients where surgery can not be completed minimal invasive
Daniel Jacobs-Tulleneers-Thevissen, MD, PhD
CONTACT
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Time frame: during surgery
Length of hospital stay
Time patient spends in hospital
Time frame: Immediate after surgery
Re-operation and re-admission rate
need for re-intervention or hospitalisation after discharge
Time frame: < 30 days after surgery
Evolution of post-operative cognition
Mini-cog clock test followed by Mini Mental State Evaluation (MMSE) if abnormal
Time frame: 3, 6, 12 months post surgery
Postoperative confusion rate
CAM-analysis
Time frame: 7 days postoperative
30- day post-operative morbidity (Clavien-Dindo classification)
minor and major postoperative complications including anastomotic leakage
Time frame: < 30 days postoperative
90- day post-operative mortality
number of patients that die after surgery
Time frame: < 90 days postoperative
1-year patient survival
number of patients that are still alive one year after surgery
Time frame: 1 year postoperatively
1-year disease free survival
number of patients that do not show disease recurrence during the first postoperative year
Time frame: 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)
Time frame: up till 12 months postoperatively