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Trial Title:
An Observational Cohort Study to Assess the Postop Activity of Colorectal Patients Undergoing Elective Surgery (PHYSPAL)
NCT ID:
NCT05934643
Condition:
Colorectal (Colon or Rectal) Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
ActivPAL accelerometer
Description:
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:
Other
Intervention name:
Hospital Anxiety and Depression Scale (HADS) Questionnaire
Description:
The use of the HADS questionnaire to ascertain if any correlation between level of
activity and and inpatient mood.
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.
Criteria for eligibility:
Study pop:
All patients presenting to Royal Derby Hospital who have gone through colorectal
multidisciplinary team (MDT) meeting with a plan for surgical resection of colorectal
cancer with curative intent.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Nottingham, Royal Derby Hospital
Address:
City:
Derby
Zip:
DE22 3DT
Country:
United Kingdom
Start date:
September 1, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
University of Nottingham
Agency class:
Other
Source:
University of Nottingham
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05934643
