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

NCT05934643 | Completed DMC

• 1 other identifier: 23025
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal (Colon or Rectal) Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Step count

  From the first postoperative day until discharge or day 7, whichever is sooner.

• Sit to stands

  From the first postoperative day until discharge or day 7, whichever is sooner.

• Time spent in bed

  From the first postoperative day until discharge or day 7, whichever is sooner.

• 30-day complication rate

  30 days from operation date.

Interventions

ActivPAL accelerometer DEVICE

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.

Hospital Anxiety and Depression Scale (HADS) Questionnaire OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham, Royal Derby Hospital

Derby, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jon Lund, DM, FRCS

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 7, 2023
• Study Start: September 1, 2023
• Primary Completion: April 24, 2024
• Study Completion: May 30, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)