Enhancing Fitness Before Pancreatic Surgery (MedEx)

Royal Surrey County Hospital NHS Foundation Trust

Status: Completed

Conditions: Pancreatitis, Chronic; Pancreatic Cancer

Treatments: Other: MedEx

Study type: Interventional

Funder types: Other

Identifiers

NCT02940067

197169

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

MedEx

Experimental group

Description:

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.

Treatment:

Other: MedEx

Standard Care

No Intervention group

Description:

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