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Clinical Trials/NCT02940067
NCT02940067
Completed
N/A

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

Royal Surrey County Hospital NHS Foundation Trust1 site in 1 country20 target enrollmentMarch 28, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Royal Surrey County Hospital NHS Foundation Trust
Enrollment
20
Locations
1
Primary Endpoint
Peak power - measured using cardiopulmonary exercise testing
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2017
End Date
August 20, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Royal Surrey County Hospital NHS Foundation Trust
Responsible Party
Principal Investigator
Principal Investigator

Jason George

Research Fellow

Royal Surrey County Hospital NHS Foundation Trust

Eligibility 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

Outcomes

Primary Outcomes

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

  • Length of stay(From date of operation until date of discharge)
  • Sleep(Change in sleep quality between start and end of prehabilitation (4 weeks))
  • Fatigue(Change in fatigue levels between start and end of prehabilitation (4 weeks))
  • Insulin sensitivity - measured using the insulin clamp test(Change in insulin sensitivity between start and end of prehabilitation (4 weeks))
  • Complication rate(From date of operation until date of discharge)
  • Well-being(Change in well-being scores between start and end of prehabilitation (4 weeks))

Study Sites (1)

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