Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversitair Ziekenhuis Brussel
About this trial
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;
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients ≥ 70 years with colorectal cancer
eligible for colorectal surgery after multidisciplinary board evaluation and patient consent
Disqualifiers
decline in cognitive function after geriatric evaluation
emergency surgery
life expectancy < 3 months
Trial design
Design model
Single group
Treatments tested in this trial
Geriatric Assessment
Diagnostic testGeriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Older patients with colorectal cancerOther 1 intervention
Trial outcomes
Primary outcomes
1
Change 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 surgery2
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 surgery3
Change in Quality of Life
Measurement of QoL using validated EORTC QoL questionnaire
Time frame
Before and 3-6-12 months after surgerySecondary outcomes
1
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 surgery2
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 surgery3
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 surgery4
Conversion-rate to open surgery
Number of patients where surgery can not be completed minimal invasive
Time frame
during surgeryOther outcomes
1
pathological analysis resection specimen
tumor stage, lymph node yield, resection quality
Time frame
immediately after surgery2
blood loss
estimated blood loss during surgery
Time frame
during surgerySponsors and contacts
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Source ClinicalTrials.gov