Enhancing Fitness Before Pancreatic Surgery (MedEx Trial)
Research type
Research Study
Full title
A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection
IRAS ID
197169
Contact name
Jason George
Contact email
Sponsor organisation
Royal Surrey County Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Pancreatic surgery is high risk with complication rates ranging between 30-60%. 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 in abdominal surgery. 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. Fish oils have an anti-inflammatory effect and may minimise weight loss associated with pancreatic cancer, whilst olive oil may also decrease inflammation.
The proposed research will investigate a prehabilitation programme, incorporating exercise and nutritional supplementation, to improve cardiopulmonary and metabolic fitness (measured by insulin sensitivity) before surgery. The programme will involve supervised exercise sessions at a specialist sports training complex. This will occur over four weeks prior to surgery, supervised closely by exercise physiologists. In parallel, patients will consume fish oil supplements and olive oil daily.
Data will be collected from cardiopulmonary exercise tests and pre- and post-operative blood tests. The “clamp test” is the gold standard for measuring insulin resistance – how well cells in skeletal muscle and fat can absorb glucose for a given amount of insulin. We will use the clamp test to measure insulin sensitivity before and after prehabilitation. Collectively, these data will show the effect of prehabilitation on cardiopulmonary and metabolic fitness in patients with pancreatic disease.
REC name
Wales REC 7
REC reference
16/WA/0396
Date of REC Opinion
10 Jan 2017
REC opinion
Further Information Favourable Opinion