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

Colorectal (Colon or Rectal) Cancer Clinical Trial

— PHYSPAL  

Official title:

An Observational Cohort Study to Assess the Postoperative Physical Activity of Patients Undergoing Elective Colorectal Resection.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05934643
• Other study ID #: 23025
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: University of Nottingham
• Contact: Melanie Paul, MBChB, MSc
• Phone: (+44) 01332724640
• Email: melanie.paul[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal (Colon or Rectal) Cancer
• Colorectal Neoplasms

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	University of Nottingham, Royal Derby Hospital	Derby

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average daily energy expenditure in MET.h	Using the ActivPAL accelerometers, to assess the MET.h per each postoperative day	30 days from operation date
Secondary	Step count	Using the ActivPAL accelerometers, record average daily step count	From the first postoperative day until discharge or day 7, whichever is sooner.
Secondary	Sit to stands	Using the ActivPAL accelerometers, record average daily sit-to-stand count	From the first postoperative day until discharge or day 7, whichever is sooner.
Secondary	Time spent in bed	Using the ActivPAL accelerometers, record average time spent in bed in hours.	From the first postoperative day until discharge or day 7, whichever is sooner.
Secondary	30-day complication rate	All postoperative complications will be recorded and classified as per the Clavien-Dindo classification.	30 days from operation date.