Comparison of frailty screening instruments in terms of their ability to predict outcomes of colorectal surgery in older adults
| ISRCTN | ISRCTN63830056 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63830056 |
| Secondary identifying numbers | Version 3, 12-06-2020 |
- Submission date
- 03/07/2020
- Registration date
- 02/08/2020
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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 December 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Katleen Fagard
katleen.fagard@uzleuven.be
Contact information
Scientific
Leuven Universisty Hospitals, Geriatrics Department
Herestraat 49
Leuven
3000
Belgium
 ORCID ID |
0000-0001-5886-4432 |
|---|---|
| Phone | +32 (0)16347156 |
| katleen.fagard@uzleuven.be |
Scientific
Department of Public Health and Primary Care
Division of Gerontology and Geriatrics
KU Leuven
Herestraat 49
Leuven
3000
Belgium
| ORCID ID |
0000-0003-1560-2277 |
|---|---|
| Phone | +32 (0)16347156 |
| mieke.deschodt@kuleuven.be |
Study information
| Study design | Prospective single-centre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | Comparison of preoperative frailty screening instruments in older adults undergoing elective colorectal surgery: a prospective observational study |
| Study acronym | G-ERAS frailty study |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 06/07/2020 |
| Completion date | 23/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 135 |
| Total final enrolment | 172 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/07/2020 |
| Date of final enrolment | 08/07/2022 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Leuven
3000
Belgium
Sponsor information
Hospital/treatment centre
Geriatrics Department
Herestraat 49
Leuven
3000
Belgium
| Phone | +32 (0)16347156 |
|---|---|
| katleen.fagard@uzleuven.be | |
| Website | https://www.uzleuven.be/nl/geriatrie |
"ROR" |
https://ror.org/0424bsv16 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 12/06/2020 | 07/08/2020 | No | No | |
| Results article | 29/12/2024 | 21/01/2025 | Yes | No |
Additional files
- ISRCTN63830056_PROTOCOL_12Jun20.docx
- uploaded 07/08/2020
Editorial Notes
21/01/2025: Publication reference added.
13/12/2023: The intention to publish date was changed from 31/12/2023 to 31/07/2024.
19/01/2023: The overall end date was changed from 08/01/2023 to 23/12/2022. Contact details updated.
04/08/2022: The final enrolment number has been added.
15/03/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/03/2022 to 08/07/2022.
2. The overall end date was changed from 31/08/2022 to 08/01/2023.
3. The intention to publish date was changed from 31/12/2022 to 31/12/2023.
4. The plain English summary was updated to reflect these changes.
5. The trial website was added.
07/08/2020: Uploaded protocol (not peer reviewed) Version n/a 12 June 2020.
16/07/2020: Trial's existence confirmed by Ethics Committee Research UZ / KU Leuven.
