Perioperative Cognitive Trajectories in Deferred Surgery (CoTELE-SURGE)

NCT ID: NCT04787536

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-10
• Study Completion Date: 2023-06-30

Brief Summary

Cognition is the way people use their brains to think, understand, remember and make decisions. Cognitive changes are often seen even up to 1 year after surgery. Whether these changes are more than what is expected for someone's age and morbidities is still uncertain. Due to the COVID-19 emergency, many elective surgeries have been delayed, which is stressful for patients, but also represents an opportunity of understanding better how surgery can impact cognitive abilities. The purpose of this study is to explore if and how cognitive performance changes over time for patients aged 65 years or older, whose surgery has been postponed.

due to the COVID-19 emergency, following and assessing the cognitive performance of these patients over time before and after surgery. In particular, in this study, the participant's cognitive performance will be assessed periodically with a computer-based instrument for cognitive testing, self-administered at home, in which tests are based on playing cards.

Detailed Description

The primary objectives of the project are to describe perioperative cognitive trajectories of older patients whose elective noncardiac surgery has been deferred because of the COVID-19 emergency, and explore the intra-individual changes in these trajectories from before to after surgery, through periodic remote self-administered cognitive testing. Secondarily, in the same patients, the investigators will also describe the perioperative trajectories in depressive symptoms and pain, and study their correlation with the trajectories in cognitive performance.

The study will be conducted remotely and virtually. The investigators will have an initial videoconference with the participant (and a support person if necessary) to explain the computerized cognitive test battery (i.e. the Cogstate Brief battery, CBB), and train on self-administration through a user-specific link. At each due assessment, the research team will call the participant to remind to complete the CBB; and to assess depressive symptoms, pain, and collect data on intercurrent clinical events (i.e. medication changes, hospitalization, ED or urgent care visits).

Conditions

Postoperative Cognitive Dysfunction; Depressive Symptoms; Postoperative Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study cohort

Patients aged 65 years or greater; scheduled to perform noncardiac elective surgery expected to require at least an overnight stay in hospital after surgery; surgery deferred, with a known or probable surgery date in ≥6 weeks

Non-cardiac surgery

Intervention Type: PROCEDURE

Non-cardiac surgery excluding cranial neurosurgery

Interventions

Non-cardiac surgery

Non-cardiac surgery excluding cranial neurosurgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. age 65 years or greater;

2. patient scheduled to perform noncardiac elective surgery expected to require at least an overnight stay in hospital after surgery;

3. surgery deferred, with a known or probable surgery date in ≥6 weeks;

4. informed consent provided.

Exclusion Criteria

1. patient undergoing cardiac surgery or cranial neurosurgery;

2. known history of dementia;

3. unavailability of tablet or computer with an internet connection for remote assessment; 4. patient unable to interact with a tablet or computer due to language, visual, or hearing impairment, or any severely limited mobility of the upper limb joints;

5. patient unable to understand spoken or written English; 6. surgery delayed for an intercurrent clinical event

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Maura Marcucci

Assistant Professor, Department of Health Research Methods, Evidence and Impact and Department of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maura Marcucci, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster Univesity

Locations

McMaster University

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Maura Marcucci, MD

Role: CONTACT

marcum2@mcmaster.ca

9055274322 ext. 40594

Maram Khaled, MBBCh, MSc

Role: CONTACT

khalem3@mcmaster.ca

9059220293

Facility Contacts

Maura Marcucci, MD

Role: primary

marcum2@mcmaster.ca

9055274322 ext. 40594

Maram Khaled, MBBCh, MSc

Role: backup

khalem3@mcmaster.ca

9059220293

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

10829

Identifier Type: -

Identifier Source: org_study_id