Prehabilitation in Liver Surgery

NCT01523353 | Completed Phase 1

• 1 other identifier: 11/H1005/3
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Each year in the UK around 1500 patients undergo surgery for bowel cancer that has spread to the liver. This is major surgery that offers a chance of cure, but can be associated with complications. Fitter patients are less likely to have serious complications. We are interested in finding out whether a short exercise program can improve patient fitness before surgery and whether this can reduce surgical complications. We plan to measure the fitness of patients who are going to have liver surgery. We will then give them an exercise programme for 4 weeks, after which we will assess their fitness again. We are also interested in whether fitter people have better Liver function. To assess this we will take a small sample of liver tissue during the operation for laboratory analysis of its function. Hypothesis

1. 1.A short period of exercise can significantly improve fitness prior to liver surgery
2. 2.Greater Fitness is associated with better liver function.

Conditions

Colorectal Cancer; Colorectal Liver Metastasis; Liver Surgery; Exercise Intervention

Keywords

Prehabilitation; Exercise; Colorectal Cancer; Surgery

Outcome Measures

Primary Outcomes (1)

• Anaerobic threshold prior to liver resection

  This is a measure of cardiopulmonary fitness as detected by a cardiopulmonary exercise test.

  4 weeks

Secondary Outcomes (8)

• Hospital Length of stay

  6 weeks

• Post operative morbidity

  3 months

• Quality of Life

  4 months

• Mortality

  30 day and 90 day postoperative

• Attendance at exercise sessions

  6 weeks

Study Arms (2)

Exercise Intervention

ACTIVE COMPARATOR

4 week personalised exercise program on a static bicycle.

Behavioral: Exercise Intervention

Control Arm

NO INTERVENTION

Patients having standard preoperative preparation and advice.

Interventions

Exercise Intervention BEHAVIORAL

4 week personalised exercise program on a static cycle. Supervised in a hospital environment

Exercise Intervention

Eligibility Criteria

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

You may qualify if:

• Planned resection of colorectal liver metastasis
• Able to perform cycle based exercise program
• Age over 18

You may not qualify if:

• Unable to consent
• Unable to perform cycle based exercise program
• Age under 18

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Aintree University Hospital

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

Related Publications (1)

• Dunne DF, Jack S, Jones RP, Jones L, Lythgoe DT, Malik HZ, Poston GJ, Palmer DH, Fenwick SW. Randomized clinical trial of prehabilitation before planned liver resection. Br J Surg. 2016 Apr;103(5):504-12. doi: 10.1002/bjs.10096. Epub 2016 Feb 11.

  PMID: 26864728 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

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; Behavior

Study Officials

• Declan FJ Dunne, MBChB(Hons)

  Liverpool University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Research Fellow

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 1, 2012
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 17, 2013

Record last verified: 2012-02

Locations

GB (1)