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Enhancing Fitness Before Pancreatic Surgery (MedEx)

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ClinicalTrials.gov Identifier: NCT02940067
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
University of Surrey
Information provided by (Responsible Party):
Jason George, Royal Surrey County Hospital NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Pancreatitis, Chronic Other: MedEx Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection
Actual Study Start Date : March 28, 2017
Actual Primary Completion Date : June 21, 2018
Actual Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine


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 Name: Prehabilitation

No Intervention: Standard Care
This group will follow current standard preoperative care before scheduled pancreatic resection.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940067


Locations
United Kingdom
MATTU, Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7WG
Sponsors and Collaborators
Royal Surrey County Hospital NHS Foundation Trust
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:
Responsible Party: Jason George, Research Fellow, Royal Surrey County Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02940067     History of Changes
Other Study ID Numbers: 197169
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jason George, Royal Surrey County Hospital NHS Foundation Trust:
prehabilitation
pancreatectomy
nutrition
exercise

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatitis
Pancreatitis, Chronic
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases