CPET in Colorectal Surgery

NCT02298907 | Completed

• 1 other identifier: 14/EM/1038
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is a retrospective analysis of prospectively collected clinical data. Anonymized data from patients collected during routine clinical care from 7 major colorectal units in the UK who perform pre-operative cardiopulmonary exercise testing will be pooled at a central location (Aintree University Hospitals, Liverpool) and used to validate the relationship between cardiopulmonary exercise testing (CPET) variables and short term post-operative outcomes after major colorectal surgery. Here the investigators will attempt to validate a study entitled "Cardiopulmonary exercise variables are associated with postoperative morbidity after major colonic surgery - a prospective blinded observational study" previously published by our team in Liverpool .

Conditions

Colorectal Cancer; Surgery

Keywords

colorectal cancer; surgery; cardiopulmonary exercise testing; perioperative; fitness

Outcome Measures

Primary Outcomes (1)

• Oxygen uptake at lactate threshold

  baseline

Secondary Outcomes (4)

• Oxygen uptake at peak

  baseline

• Power output at lactate threshold and peak exercise

  baseline

• Ventilatory equivalents at lactate threshold and peak exercise

  baseline

• Number of patients with adverse post-operative outcome measures

  post-operatively

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive colorectal cancer patients recruited via colorectal multidisciplinary meeting

You may qualify if:

• all patients aged \>18 years considered for major colorectal surgery (benign or malignant) and undergoing an enhanced recovery programme after surgery

You may not qualify if:

• patients scheduled for neoadjuvant cancer therapy, patients physically unable to perform a CPET on a cycle ergometer, patients having no surgery performed or interim emergency surgery, patients lacking complete in-hospital morbidity data.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead
• Medway NHS Foundation Trust: collaborator
• Maidstone & Tunbridge Wells NHS Trust: collaborator
• Torbay and South Devon NHS Foundation Trust: collaborator
• University Hospital Plymouth NHS Trust: collaborator

Study Sites (1)

Aintree University Hospital

Liverpool, L97AL, United Kingdom

Location

Related Publications (1)

• West MA, Lythgoe D, Barben CP, Noble L, Kemp GJ, Jack S, Grocott MP. Cardiopulmonary exercise variables are associated with postoperative morbidity after major colonic surgery: a prospective blinded observational study. Br J Anaesth. 2014 Apr;112(4):665-71. doi: 10.1093/bja/aet408. Epub 2013 Dec 8.

  PMID: 24322573 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Malcolm West

  Aintree University Hospitals NHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: November 24, 2014
• Study Start: June 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 9, 2022

Record last verified: 2015-06

Locations

GB (1)