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Completed

NCT Number: NCT02940067

Enhancing Fitness Before Pancreatic Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MATTU, Royal Surrey County Hospital

Guildford, Surrey, GU2 7WG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MedEx

Other

A combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery

Other names: Prehabilitation

Primary outcomes

  1. Peak power - measured using cardiopulmonary exercise testing

    Time frame: Change in peak power between start and end of prehabilitation (4 weeks)

    cardiopulmonary fitness

Secondary outcomes

  1. Insulin sensitivity - measured using the insulin clamp test

    Time frame: Change in insulin sensitivity between start and end of prehabilitation (4 weeks)

    insulin sensitivity

  2. Length of stay

    Time frame: From date of operation until date of discharge

    Recovery

  3. Complication rate

    Time frame: From date of operation until date of discharge

    Morbidity

  4. Sleep

    Time frame: Change in sleep quality between start and end of prehabilitation (4 weeks)

    Sleep Quality

  5. Fatigue

    Time frame: Change in fatigue levels between start and end of prehabilitation (4 weeks)

    Fatigue Levels

  6. Well-being

    Time frame: Change in well-being scores between start and end of prehabilitation (4 weeks)

    Sense of Well-being

Sponsors and collaborators

Lead sponsor

Royal Surrey County Hospital NHS Foundation Trust

Other

Collaborators

  • University of Surrey

Registry information

Official study title

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

Acronym: MedEx

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2016
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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