Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer (ROBO-G)

April 28, 2023 updated by: Universitair Ziekenhuis Brussel

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;

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Older patients with colorectal cancer
Patients undergo geriatric assessment including evaluation of cognitive function, functional status and quality of life
Diagnostic test: Geriatric Assessment
Geriatric assessment to evaluate cognitive function, functional status and quality of life before and after surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Before and 3-6-12 months after surgery
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)
Before and 3-6-12 months after surgery
Change in Quality of Life
Time Frame: Before and 3-6-12 months after surgery
Measurement of QoL using validated EORTC QoL questionnaire
Before and 3-6-12 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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 functional recovery at 12 months after initial func-tional decline after surgery
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
Percentage of patients demonstrating a significant decrease/improvement of QoL at 3,6,12 months after surgery
3-6-12 months after surgery
Conversion-rate to open surgery
Time Frame: during surgery
Number of patients where surgery can not be completed minimal invasive
during surgery
Length of hospital stay
Time Frame: Immediate after surgery
Time patient spends in hospital
Immediate after surgery
Re-operation and re-admission rate
Time Frame: < 30 days after surgery
need for re-intervention or hospitalisation after discharge
< 30 days after surgery
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
3, 6, 12 months post surgery
Postoperative confusion rate
Time Frame: 7 days postoperative
CAM-analysis
7 days postoperative
30- day post-operative morbidity (Clavien-Dindo classification)
Time Frame: < 30 days postoperative
minor and major postoperative complications including anastomotic leakage
< 30 days postoperative
90- day post-operative mortality
Time Frame: < 90 days postoperative
number of patients that die after surgery
< 90 days postoperative
1-year patient survival
Time Frame: 1 year postoperatively
number of patients that are still alive one year after surgery
1 year postoperatively
1-year disease free survival
Time Frame: 1 year postoperatively
number of patients that do not show disease recurrence during the first postoperative year
1 year postoperatively
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)
up till 12 months postoperatively

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pathological analysis resection specimen
Time Frame: immediately after surgery
tumor stage, lymph node yield, resection quality
immediately after surgery
blood loss
Time Frame: during surgery
estimated blood loss during surgery
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitair Ziekenhuis Brussel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Jacobs-Tulleneers-Thevissen, MD, PhD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UZB-HLK: EVE-DJTT-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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