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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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Older patients with colorectal cancer | Other | Patients undergo geriatric assessment including evaluation of cognitive function, functional status and quality of life |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geriatric Assessment | Diagnostic Test | Geriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pathological analysis resection specimen | tumor stage, lymph node yield, resection quality | immediately after surgery |
| blood loss | estimated blood loss during surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellen Van Eetvelde, MD | Contact | +324775656 | ellen.vaneetvelde@uzbrussel.be | |
| Daniel Jacobs-Tulleneers-Thevissen, MD, PhD | Contact | +324775656 | daniel.jacobs-tulleneers-thevissen@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Jacobs-Tulleneers-Thevissen, MD, PhD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Brussels | Belgium |
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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 |
| during surgery |
| Universitair Ziekenhuis Brussel | Recruiting | Jette | 1090 | Belgium |
|