An Observational Cohort Study to Assess the Postop Activity of Colorectal Patients Undergoing Elective Surgery (PHYSPAL)

NCT ID: NCT05934643

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-05-30

Brief Summary

All participants will have a physical activity monitor placed onto the right thigh in the midline which will start collecting data at midnight on the first postoperative day. This will continue until discharge or day 7, whichever is earlier. This is a non-invasive measure of activity and can discriminate between whether a patient is lying, sitting, standing or walking. There is no control group.

Detailed Description

Recruited patients from the colorectal clinic at the Royal Derby Hospital will be invited to be included in the study, and can either attend the University of Nottingham, Centre Of Metabolism, Ageing & Physiology (COMAP) research group unit at the Royal Derby Hospital Centre or discuss the trial in detail over the phone after which a consent form will be sent to them (either by post or email). If they agree to inclusion in the study the consent form will be brought with them to be completed on the day of surgery. On the morning of surgery they will have their consent recorded and the activPAL™ accelerometer applied to the anterior thigh.

The activPAL™ is a non-invasive physical monitor that records periods spent, lying, walking and engaging in more strenuous activity. This will remain in situ for 7 days, or until discharge, whichever comes first. The investigators will ask participants to complete a short diary to note down any times the monitor is removed and the time of sleep and waking. After removal - the data is uploaded (it does not include any person-identifiable data) for analysis using software on a local computer in the COMAP unit. After discharge, they will have 2 x telephone calls and/or emails at day 10 and at day 28 to follow up from the research team to monitor progress for the next 30 days. If they develop any complications including readmission data within that time period, this will be collected from the participants' notes along with demographic data and postoperative pathology and recorded. Complications will be graded as per the Clavien-Dindo Classification system.

On postoperative day 3, day 5 and day 7 (if still an inpatient) they will also be asked to complete the Hospital Anxiety and Depression Scale (HADS) paper questionnaire. Just prior to discharge, they will complete the discharge questionnaire.

Conditions

Colorectal (Colon or Rectal) Cancer

Study Design

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

Interventions

ActivPAL accelerometer

All patient will have an accelerometer (activPAL) applied to characterise the type and quantity of movement during the inpatient postoperative period after undergoing major surgery for colorectal cancer surgery.

Intervention Type: DEVICE

Hospital Anxiety and Depression Scale (HADS) Questionnaire

The use of the HADS questionnaire to ascertain if any correlation between level of activity and and inpatient mood.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 18 years and over
• Clinical diagnosis of colorectal cancer due to undergo surgical resection with curative intent
• Must be able to give informed consent

Exclusion Criteria

• Lacking capacity to consent
• Undergoing emergency surgery
• Undergoing defunctioning surgery prior to neoadjuvant treatment
• Undergoing surgery with palliative intent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Lund, DM, FRCS

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

University of Nottingham, Royal Derby Hospital

Derby, , United Kingdom

Countries

United Kingdom

Other Identifiers

23025

Identifier Type: -

Identifier Source: org_study_id