Clinical trial NCT05848609: Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer
Official title: Prospective Evaluation of Functional Status and Quality of Life in Older Patients With Colorectal Cancer Undergoing Robotic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Surgery
Geriatric Assessment
Quality of Life
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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;


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

Primary outcomes:
measure: Change in frailty status G8 status
timeFrame: Before and 3-6-12 months after surgery
measure: Change in frailty status GFI status
timeFrame: Before and 3-6-12 months after surgery
measure: Change in Quality of Life
timeFrame: Before and 3-6-12 months after surgery
Secondary outcomes:
measure: Percentage (%) of patients demonstrating functional improvement at 3, 6 and 12 months after surgery
timeFrame: 3-6-12 months after surgery
measure: Percentage of patients demonstrating functional recovery at 12 months after initial func-tional decline after surgery
timeFrame: 3-6-12 months after surgery
measure: Percentage of patients demonstrating a significant decrease/improvement of QoL at 3,6,12 months after surgery
timeFrame: 3-6-12 months after surgery
measure: Conversion-rate to open surgery
timeFrame: during surgery
measure: Length of hospital stay
timeFrame: Immediate after surgery
measure: Re-operation and re-admission rate
timeFrame: < 30 days after surgery
measure: Evolution of post-operative cognition
timeFrame: 3, 6, 12 months post surgery
measure: Postoperative confusion rate
timeFrame: 7 days postoperative
measure: 30- day post-operative morbidity (Clavien-Dindo classification)
timeFrame: < 30 days postoperative
measure: 90- day post-operative mortality
timeFrame: < 90 days postoperative
measure: 1-year patient survival
timeFrame: 1 year postoperatively
measure: 1-year disease free survival
timeFrame: 1 year postoperatively
measure: Comparison in outcome parameters between frail patients (abnormal screening) versus fit patients
timeFrame: up till 12 months postoperatively
Other outcomes:
measure: pathological analysis resection specimen
timeFrame: immediately after surgery
measure: blood loss
timeFrame: during surgery
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Daniel Jacobs-Tulleneers-Thevissen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: