Colorectal SurgeryROBO-GNCT05848609
Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer
A study testing Geriatric Assessment in people with Colorectal Surgery and Geriatric Assessment, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
Trial 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; Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectal Surgery, Geriatric Assessment, Quality of Life
- What is being tested?
- Geriatric Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 Mar 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients ≥ 70 years with colorectal cancer
- eligible for colorectal surgery after multidisciplinary board evaluation and patient consent
Who cannot join
- decline in cognitive function after geriatric evaluation
- emergency surgery
- life expectancy < 3 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Daniel Jacobs-Tulleneers-Thevissen, MD, PhD contact
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels
Ellen Van Eetvelde, MD, ellen.vaneetvelde@uzbrussel.be
- Recruiting
Universitair Ziekenhuis Brussel
Jette, 1090
Ellen Van Eetvelde, MD, ellen.vaneetvelde@uzbrussel.be
About this study
Official title: Prospective Evaluation of Functional Status and Quality of Life in Older Patients With Colorectal Cancer Undergoing Robotic Surgery
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;
- Conditions
- Colorectal Surgery, Geriatric Assessment, Quality of Life
- Being tested
- Geriatric Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric AssessmentDiagnostic test
Geriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery
| Study group | Role | What they receive |
|---|---|---|
| Older patients with colorectal cancer | Other | Patients undergo geriatric assessment including evaluation of cognitive function, functional status and quality of life Receives: Diagnostic Test: Geriatric Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frailty status G8 status
Measurement of functional status using the G8, Flemish version of the Triage Risk Screening Tool (fTRST)
Measured: 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)
Measured: Before and 3-6-12 months after surgery
Change in Quality of Life
Measurement of QoL using validated EORTC QoL questionnaire
Measured: Before and 3-6-12 months after surgery
Secondary outcomes (13)
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
Measured: 3-6-12 months after surgery
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
Measured: 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
Measured: 3-6-12 months after surgery
Conversion-rate to open surgery
Number of patients where surgery can not be completed minimal invasive
Measured: during surgery
Length of hospital stay
Time patient spends in hospital
Measured: Immediate after surgery
Re-operation and re-admission rate
need for re-intervention or hospitalisation after discharge
Measured: < 30 days after surgery
Evolution of post-operative cognition
Mini-cog clock test followed by Mini Mental State Evaluation (MMSE) if abnormal
Measured: 3, 6, 12 months post surgery
Postoperative confusion rate
CAM-analysis
Measured: 7 days postoperative
30- day post-operative morbidity (Clavien-Dindo classification)
minor and major postoperative complications including anastomotic leakage
Measured: < 30 days postoperative
90- day post-operative mortality
number of patients that die after surgery
Measured: < 90 days postoperative
1-year patient survival
number of patients that are still alive one year after surgery
Measured: 1 year postoperatively
1-year disease free survival
number of patients that do not show disease recurrence during the first postoperative year
Measured: 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)
Measured: up till 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start15 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Jacobs-Tulleneers-Thevissen, MD, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848609
- Sponsor's protocol ID
- UZB-HLK: EVE-DJTT-002
- Acronym
- ROBO-G
- Status last verified
- Apr 2023
- First submitted
- 19 Sep 2022
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Functional Status and Quality of Life in Older Patients With Colorectal Cancer Undergoing Robotic Surgery
- ClinicalTrials.gov ID
- NCT05848609
- Acronym / sponsor ID
- ROBO-G / UZB-HLK: EVE-DJTT-002
- Conditions
- Colorectal Surgery, Geriatric Assessment, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older patients with colorectal cancer | Other | Diagnostic Test: Geriatric AssessmentPatients undergo geriatric assessment including evaluation of cognitive function, functional status and quality of life |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- patients ≥ 70 years with colorectal cancer
- eligible for colorectal surgery after multidisciplinary board evaluation and patient consent
Key exclusion criteria (3 listed)
- decline in cognitive function after geriatric evaluation
- emergency surgery
- life expectancy < 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric AssessmentGeriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery | Diagnostic test | Older patients with colorectal cancer |
Primary outcome
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)
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)
Change in Quality of Life
Time frame: Before and 3-6-12 months after surgery
Measurement of QoL using validated EORTC QoL questionnaire
13 secondary outcomes
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
Comparison in outcome parameters between frail patients (abnormal screening) versus fit patients
Time frame: up till 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Jacobs-Tulleneers-Thevissen, MD, PhD contact
Daniel Jacobs-Tulleneers-Thevissen, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric Assessment in people with Colorectal Surgery and Geriatric Assessment, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen Van Eetvelde, MD (+324775656, ellen.vaneetvelde@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frailty status G8 status (time frame: Before and 3-6-12 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.