Enhancing Fitness Before Pancreatic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-28

Study Completion Date

2018-08-20

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pancreatic Cancer Pancreatitis, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MedEx

Intervention Type OTHER

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

Standard Care

This group will follow current standard preoperative care before scheduled pancreatic resection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MedEx

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

Intervention Type OTHER

Other Intervention Names

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Prehabilitation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No