Enhancing Fitness Before Pancreatic Surgery

Study Overview
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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.

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.

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

Conditions
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Pancreatic Cancer, Pancreatitis, Chronic

Intervention / Treatment
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* Other: MedEx


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MedEx<br>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<br>* A combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery<br>* Other names: Prehabilitation;|
| No Intervention: Standard Care<br>This group will follow current standard preoperative care before scheduled pancreatic resection. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prehabilitation, pancreatectomy, nutrition, exercise