Plain English Summary
Background and study aims
The aging of society leads to increasing demand for colorectal surgical procedures in older patients. Frail older patients with a high risk of experiencing adverse outcomes after surgery should be identified before surgery in order to determine who would benefit most from additional geriatric care and follow-up. Many frailty screening instruments have been developed, but due to a lack of comparative studies, there is still no consensus as to which screening instrument would be most appropriate for the preoperative practice in elective colorectal surgery.
This study will be performed as part of a quality improvement project in the UH Leuven, in which a surgical-geriatric co-management program will be developed and implemented in the abdominal surgery department. The aim of this study is to investigate which frailty screening instrument would be best suited to select patients for the co-management program.
Who can participate?
Patients planned for elective colorectal resection for cancer or benign disease in an enhanced recovery after surgery pathway, aged 70 and over on the day of surgery
What does the study involve?
At the preoperative consultation (approximately 1 month before surgery), after agreement to participate, three short functional tests will be performed: handgrip strength, mini-cog test, timed-up-and-go test. This will take about 5 minutes. The patients will also receive a questionnaire to complete with the research assistant or at home. Completion of the questionnaire will take about 15 minutes. Further information will be collected by consulting the electronic medical record and, if necessary, the treating physician or nurse. Outcome data will be collected at 1 week and 1, 3 and 6 months after the surgery.
What are the possible benefits and risks of participating?
Participants will not receive any compensation for participation in this study. The study will lead to better knowledge about frailty screening and postoperative outcomes in relation to frailty in older patients undergoing elective colorectal resections. There is a small chance that participants will lose their balance when performing the timed-up-and-go test. However, this test will always be conducted under the supervision of a person with a background in healthcare. Possible risks are covered by an insurance policy.
Where is the study run from?
University Hospital of Leuven (Belgium)
When is the study starting and how long is it expected to run for?
July 2020 to August 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Katleen Fagard
katleen.fagard@uzleuven.be
Trial website
Contact information
Type
Scientific
Primary contact
Dr Katleen Fagard
ORCID ID
http://orcid.org/0000-0001-5886-4432
Contact details
Leuven Universisty Hospitals
Geriatrics Department
Herestraat 49
Leuven
3000
Belgium
+32 (0)16347156
katleen.fagard@uzleuven.be
Type
Public
Additional contact
Miss Lisa Geyskens
ORCID ID
Contact details
Leuven University Hospitals Geriatrics Department
Herestraat 49
Leuven
3000
Belgium
+32 (0)16347156
lisa.geyskens@uzleuven.be
Type
Scientific
Additional contact
Prof Mieke Deschodt
ORCID ID
http://orcid.org/0000-0003-1560-2277
Contact details
Department of Public Health and Primary Care
Division of Gerontology and Geriatrics
KU Leuven
Herestraat 49
Leuven
3000
Belgium
+32 (0)16347156
mieke.deschodt@kuleuven.be
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Version 3, 12-06-2020
Study information
Scientific title
Comparison of preoperative frailty screening instruments in older adults undergoing elective colorectal surgery: a prospective observational study
Acronym
G-ERAS frailty study
Study hypothesis
The aim of this study is to compare the diagnostic characteristics of frailty screening instruments to identify a target group that will benefit most from geriatric-surgical co-management to avoid adverse postoperative outcomes, such as postoperative complications, prolonged length of stay, functional decline and higher level of care needs.
Ethics approval
Approved 24/06/2020, Ethics Committee Research UZ / KU Leuven (EC Research, Herestraat 49, 3000 Leuven, Belgium; +32 (0)16 34 86 00; ec@uzleuven.be), ref: S 63864
Study design
Prospective single-centre observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format. Please use contact details to request a participant information sheet
Condition
Frailty in older adults undergoing elective colorectal resections
Intervention
At the preoperative consultation (approximately 1 month before surgery), after agreement to participate, three short functional tests will be performed: hand grip strength, mini-cog test, timed-up-and-go test. This will take approximately 5 minutes. The patients will also receive a questionnaire to complete with the research assistant or at home. Completion of the questionnaire will take approximately 15 minutes. Further information will be collected by consulting the electronic medical record and, if necessary, the treating physician or nurse.
Outcome data will be collected at 1 week and 1, 3 and 6 months after the surgery.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The severity of in-hospital postoperative complications according to the Clavien-Dindo classification, assessed at discharge
Secondary outcome measures
1. Prolonged postoperative length of stay (LOS), defined as LOS > 75th percentile, assessed at discharge
2. Functional decline in basic activities of daily living (bADL), defined as the difference in bADL score compared to the preoperative score at 1 week and at 1, 3, 6 months after surgery
3. Functional decline in instrumental activities of daily living (iADL), defined as the difference in iADL score compared to the preoperative score at 1 week (if discharged) and at 1, 3, 6 months after surgery
4. Discharge to an increased level of care compared to the preoperative residence, assessed at discharge: levels of care in increasing order are:
4.1. Place of residence with same assistance compared to the preoperative situation
4.2. Place of residence with increased assistance compared to the preoperative situation
4.3. Rehabilitation/Convalescence stay
4.4. Nursing home admission
Overall trial start date
06/07/2020
Overall trial end date
31/08/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 70 and over on the day of the surgery
2. Elective colorectal resection for cancer or benign disease
3. Enhanced recovery after surgery pathway
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
135
Participant exclusion criteria
1. Patients lacking decision-making capacity
2. Patients undergoing emergency surgery, reoperations for surgical complications, hyperthermic intraperitoneal chemotherapy, stoma closure or transit repair, rectopexy or prolapse surgery, trans-anal procedures, proctological operations or local stoma procedures
3. Patients whose surgery was omitted
4. Patients who are unable to understand and speak Dutch
Recruitment start date
08/07/2020
Recruitment end date
01/03/2022
Locations
Countries of recruitment
Belgium
Trial participating centre
University Hospital of Leuven (UH Leuven)
Geriatrics Department University Hospitals Leuven, Herestraat 49
Leuven
3000
Belgium
Sponsor information
Organisation
Universitaire Ziekenhuizen Leuven
Sponsor details
Geriatrics Department
Herestraat 49
Leuven
3000
Belgium
+32 (0)16347156
katleen.fagard@uzleuven.be
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results of the study will be submitted by the core research team as conference abstracts and as publications in professional journals and international peer-reviewed journals. Before the start of the study, a publication policy will be distributed for approval.
IPD sharing statement
Anonymized study data will be available on request. Data will be collected using REDCap®, an electronic case report from (eCRF) that entails a possibility to export data into an Excel file. Colleague researchers can request all necessary data, e.g for meta-analysis, which we will send in an anonymized Excel file. Data can be requested by contacting Dr Katleen Fagard (by mail) after publication of the study in a peer-reviewed journal. The patients will have signed an informed consent form (in Dutch) in which they agree to use the collected data for scientific research and for publication, provided that the Belgian and European law concerning privacy protection is respected. This means that only anonymized data will be shared.
Intention to publish date
31/12/2022
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN63830056_PROTOCOL_12Jun20.docx uploaded 07/08/2020