Enhancing Fitness Before Pancreatic Surgery (MedEx)

August 28, 2018 updated by: Jason George, Royal Surrey County Hospital NHS Foundation Trust

A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection

This is a pilot study to investigate the effect of prehabilitation on patients undergoing elective surgery for pancreatic disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pancreatic surgery is high risk. The injury associated with surgery causes a stress response, comprising a variety of hormonal and metabolic effects. Patients undergoing pancreatic surgery experience one of the largest stress responses. Prehabilitation is the process of enhancing an individual's fitness, thereby improving tolerance to an upcoming physiological stress such as surgery. Studies involving prehabilitation have been shown to improve recovery after surgery and reduce complication rates. There are currently no published reports of prehabilitation involving patients undergoing pancreatic surgery. This research study will explore the effect of prehabilitation in these patients.

Patients with pancreatic disease are some of the least fit surgical candidates due to the disease process. Exercise training can improve physical fitness before elective abdominal surgery and nutritional supplementation can also influence clinical course via different mechanisms. Patients with pancreatic disease are often malnourished for several reasons. We propose a multimodal approach to prehabilitation involving dietary and exercise interventions during a four-week period preceding elective surgery. Core data will be collected from cardiopulmonary exercise tests and blood tests (to assess insulin sensitivity), before and after prehabilitation. Secondary outcomes such as length of stay and complications will also be measured postoperatively.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7WG
        • MATTU, Royal Surrey County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Elective pancreatic resection

Exclusion Criteria:

Contraindication to cardiopulmonary exercise testing: unstable cardiac disease, lower limb dysfunction Emergency surgery Ischaemic ECG during cardiopulmonary exercise test Allergy to fish oil or olive oil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MedEx
This group will receive nutritional supplementation (based on components of the MEDiterranean diet) and supervised EXercise training for four weeks - hence the trial name, MedEx.
Other: MedEx
A combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery
Other Names:
  • Prehabilitation
NO_INTERVENTION: Standard Care
This group will follow current standard preoperative care before scheduled pancreatic resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak power - measured using cardiopulmonary exercise testing
Time Frame: Change in peak power between start and end of prehabilitation (4 weeks)
cardiopulmonary fitness
Change in peak power between start and end of prehabilitation (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity - measured using the insulin clamp test
Time Frame: Change in insulin sensitivity between start and end of prehabilitation (4 weeks)
insulin sensitivity
Change in insulin sensitivity between start and end of prehabilitation (4 weeks)
Length of stay
Time Frame: From date of operation until date of discharge
Recovery
From date of operation until date of discharge
Complication rate
Time Frame: From date of operation until date of discharge
Morbidity
From date of operation until date of discharge
Sleep
Time Frame: Change in sleep quality between start and end of prehabilitation (4 weeks)
Sleep Quality
Change in sleep quality between start and end of prehabilitation (4 weeks)
Fatigue
Time Frame: Change in fatigue levels between start and end of prehabilitation (4 weeks)
Fatigue Levels
Change in fatigue levels between start and end of prehabilitation (4 weeks)
Well-being
Time Frame: Change in well-being scores between start and end of prehabilitation (4 weeks)
Sense of Well-being
Change in well-being scores between start and end of prehabilitation (4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Collaborators

University of Surrey

Investigators

  • Study Chair: Tim Rockall, MD FRCS, MATTU, Royal Surrey County Hospital, Guildford, Surrey
  • Study Director: Mike Scott, FRCA FFICM, MATTU, Royal Surrey County Hospital, Guildford, Surrey
  • Principal Investigator: Jason George, MA MRCS, MATTU, Royal Surrey County Hospital, Guildford, Surrey
  • Study Director: Martin Whyte, PhD FRCP, University of Surrey, Guildford, Surrey
  • Study Director: Joe Wainwright, BSc, University of Surrey and Surrey Human Performance Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2017

Primary Completion (ACTUAL)

June 21, 2018

Study Completion (ACTUAL)

August 20, 2018

Study Registration Dates

First Submitted

October 15, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (ESTIMATE)

October 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 197169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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