Condition category
Surgery
Date applied
03/07/2020
Date assigned
02/08/2020
Last edited
07/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.uzleuven.be/nl/geriatrie

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

Editorial Notes

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.