Psoas Density in Colorectal Cancer

NCT04198025 | Unknown

• 1 other identifier: Psoas Muscle Density
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is the 3rd most common cancer worldwide. In the UK, CRC is the 4th most common cancer accounting for 12% of cancers diagnosed each year with approximately 41,300 new cases diagnosed in 2014. Surgery remains the only treatment option that can reliably achieve cure from colorectal cancer and thus nearly 20,000 major bowel resections are performed for this yearly in the UK. Surgery for these cancers however carries risk of major complications and potentially death. Selecting appropriate patients for surgery remains a challenge to cancer teams. Risk factors exist for complications after surgery for CRC, many of which can be assessed and discussed with the patient prior to surgery, so that any decision to operate is with fully informed consent from the patient. Increasing attention is being paid to a patient's frailty or fitness as one of these risk factors. Our centre has previously shown that measuring the cross-sectional area of the psoas muscle (a large muscle near the spine) from preoperative imaging could predict major complications in colorectal cancer patients (Jones 2015), however specialist software and patient height is required to make this calculation. More recently we have demonstrated that the measurement of the psoas muscle density on preoperative imaging (i.e. routine CT scans that all patients have before surgery to plan treatment), may potentially be useful to predict which patients are at most risk of a major complication (Herrod 2019). If this finding holds true when tested on a larger scale, it could be used to help surgical teams make the decision on whether to offer surgical resection, what kind of operations to perform, how to best support individuals undergoing operation and to ensure that the patient has the most information available to decide what risk they are at by having major surgery.

Conditions

Cancer of Colon

Keywords

psoas muscle density; frailty

Outcome Measures

Primary Outcomes (1)

• Number of post operative complications (Clavien-Dindo grade 3-4) during inpatient hospital stay.

  Recorded post operative complications requiring intervention during post operative stay until initial discharge from hospital.

  Through study completion, an average of 10 days.

Secondary Outcomes (3)

• Post operative length of stay

  Through study completion, usually between 6-10 days.

• Mortality

  Up to 5 year follow up from operation

• Post operative complications beyond hospital discharge.

  From hospital discharge to record review (i.e. 30 days, 90 days, 2 - 5 year follow up).

Study Arms (1)

Patients who underwent colorectal resection

Patients in this observational study will have undergone CT scan as routine work up prior to resection of elective colorectal cancer. Psoas muscle density will be measured (in Hounsfield units from CT images) at lumbar vertebral level L3.

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

Retrospective analysis of patients (\>18 years old) having undergone curative colorectal resection for cancer (between 31st Aug 2013 - 31st Aug 2019) in one if this multicentre study sites. All patients must have undergone preoperative CT scan with contrast.

You may qualify if:

• Patient criteria:
• Having a major colorectal resection for the treatment of cancer
• Elective or emergency surgery
• Adults, defined as age ≥18 years of age (no maximum limit)
• Had a preoperative CT scan of the abdomen with contrast (portal venous phase)
• Operation performed between 31st Aug 2013 - 31st Aug 2019

You may not qualify if:

• Not having a preoperative CT scan with contrast

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

School of Graduate Entry Medicine, Royal Derby Hospital

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Colonic Neoplasms; Frailty

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jonathan N Lund, MD

CONTACT

01332 340131; jon.lund@nottingham.ac.uk

James EM Blackwell, PhD BMBS

CONTACT

01332 340131; james.blackwell@nhs.net

Study Design

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

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 13, 2019
• Study Start: January 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 13, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)