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NCT Number: NCT05848609

Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer

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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Key information

Conditions

Colorectal Surgery Geriatric Assessment Quality of Life

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Geriatric Assessment

Diagnostic Test

Geriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery

Primary outcomes

  1. Change in frailty status G8 status

    Time frame: Before and 3-6-12 months after surgery

    Measurement of functional status using the G8, Flemish version of the Triage Risk Screening Tool (fTRST)

  2. Change in frailty status GFI status

    Time frame: Before and 3-6-12 months after surgery

    Measurement of functional status using the Groningen Frailty Indicator (GFI) Screening Tool (fTRST)

  3. Change in Quality of Life

    Time frame: Before and 3-6-12 months after surgery

    Measurement of QoL using validated EORTC QoL questionnaire

Secondary outcomes

  1. 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 decline/improvement at 3, 6 and 12 months after surgery

  2. 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 functional recovery at 12 months after initial func-tional decline after surgery

  3. 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

    Percentage of patients demonstrating a significant decrease/improvement of QoL at 3,6,12 months after surgery

  4. Conversion-rate to open surgery

    Time frame: during surgery

    Number of patients where surgery can not be completed minimal invasive

  5. Length of hospital stay

    Time frame: Immediate after surgery

    Time patient spends in hospital

  6. Re-operation and re-admission rate

    Time frame: < 30 days after surgery

    need for re-intervention or hospitalisation after discharge

  7. Evolution of post-operative cognition

    Time frame: 3, 6, 12 months post surgery

    Mini-cog clock test followed by Mini Mental State Evaluation (MMSE) if abnormal

  8. Postoperative confusion rate

    Time frame: 7 days postoperative

    CAM-analysis

  9. 30- day post-operative morbidity (Clavien-Dindo classification)

    Time frame: < 30 days postoperative

    minor and major postoperative complications including anastomotic leakage

  10. 90- day post-operative mortality

    Time frame: < 90 days postoperative

    number of patients that die after surgery

  11. 1-year patient survival

    Time frame: 1 year postoperatively

    number of patients that are still alive one year after surgery

  12. 1-year disease free survival

    Time frame: 1 year postoperatively

    number of patients that do not show disease recurrence during the first postoperative year

  13. Comparison in outcome parameters between frail patients (abnormal screening) versus fit patients

    Time frame: up till 12 months postoperatively

    Comparison in outcome parameters between frail patients (Groningen frailty indicator ≥ 4) versus fit patients (frailty indicator < 4)

Other outcomes

  1. pathological analysis resection specimen

    Time frame: immediately after surgery

    tumor stage, lymph node yield, resection quality

  2. blood loss

    Time frame: during surgery

    estimated blood loss during surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Jacobs-Tulleneers-Thevissen, MD, PhD

CONTACT

[email protected]

+324775656

Ellen Van Eetvelde, MD

CONTACT

[email protected]

+324775656

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

Prospective Evaluation of Functional Status and Quality of Life in Older Patients With Colorectal Cancer Undergoing Robotic Surgery

Acronym: ROBO-G

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 8, 2023
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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