Colorectal Surgery, Geriatric Assessment, Quality of Life
Conditions
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;
Interventions
DIAGNOSTIC_TESTGeriatric Assessment
Geriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Quality of Life | Before and 3-6-12 months after surgery | Measurement of QoL using validated EORTC QoL questionnaire |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Conversion-rate to open surgery | during surgery | Number of patients where surgery can not be completed minimal invasive |
| Length of hospital stay | Immediate after surgery | Time patient spends in hospital |
| Re-operation and re-admission rate | < 30 days after surgery | need for re-intervention or hospitalisation after discharge |
| Evolution of post-operative cognition | 3, 6, 12 months post surgery | Mini-cog clock test followed by Mini Mental State Evaluation (MMSE) if abnormal |
| 30- day post-operative morbidity (Clavien-Dindo classification) | < 30 days postoperative | minor and major postoperative complications including anastomotic leakage |
| 90- day post-operative mortality | < 90 days postoperative | number of patients that die after surgery |
| 1-year patient survival | 1 year postoperatively | number of patients that are still alive one year after surgery |
| 1-year disease free survival | 1 year postoperatively | number of patients that do not show disease recurrence during the first postoperative year |
| 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) |
| Postoperative confusion rate | 7 days postoperative | CAM-analysis |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| pathological analysis resection specimen | immediately after surgery | tumor stage, lymph node yield, resection quality |
| blood loss | during surgery | estimated blood loss during surgery |
Countries
Belgium
Contacts
Primary ContactEllen Van Eetvelde, MD
Backup ContactDaniel Jacobs-Tulleneers-Thevissen, MD, PhD
Outcome results
None listed