Recruiting NCT05848609
Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Geriatric Assessment.
- Who it may be relevant to
- Registry conditions: Colorectal Surgery, Geriatric Assessment, Quality of Life. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Evaluation of Functional Status and Quality of Life in Older Patients With Colorectal Cancer Undergoing Robotic Surgery
Overview
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 test Geriatric Assessment
Geriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery
Primary outcome measures
- Change in frailty status G8 status [Time frame: Before and 3-6-12 months after surgery]
- Change in frailty status GFI status [Time frame: Before and 3-6-12 months after surgery]
- Change in Quality of Life [Time frame: Before and 3-6-12 months after surgery]
Secondary outcome measures (12)
- Percentage (%) of patients demonstrating functional 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 [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 [Time frame: 3-6-12 months after surgery]
- Conversion-rate to open surgery [Time frame: during surgery]
- Length of hospital stay [Time frame: Immediate after surgery]
- Re-operation and re-admission rate [Time frame: < 30 days after surgery]
- Evolution of post-operative cognition [Time frame: 3, 6, 12 months post surgery]
- Postoperative confusion rate [Time frame: 7 days postoperative]
- 30- day post-operative morbidity (Clavien-Dindo classification) [Time frame: < 30 days postoperative]
- 90- day post-operative mortality [Time frame: < 90 days postoperative]
- 1-year patient survival [Time frame: 1 year postoperatively]
- 1-year disease free survival [Time frame: 1 year postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Belgium · 2 centers
- Universitair Ziekenhuis Brussel — Brussels
- Universitair Ziekenhuis Brussel — Jette
Identifiers
NCT: NCT05848609 · UZB-HLK: EVE-DJTT-002