MATTU, Royal Surrey County Hospital
Guildford, Surrey, GU2 7WG, United Kingdom
NCT Number: NCT02940067
This is a pilot study to investigate the effect of prehabilitation on patients undergoing elective surgery for pancreatic disease.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Guildford, Surrey, GU2 7WG, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
A combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery
Other names: Prehabilitation
Time frame: Change in peak power between start and end of prehabilitation (4 weeks)
cardiopulmonary fitness
Time frame: Change in insulin sensitivity between start and end of prehabilitation (4 weeks)
insulin sensitivity
Time frame: From date of operation until date of discharge
Recovery
Time frame: From date of operation until date of discharge
Morbidity
Time frame: Change in sleep quality between start and end of prehabilitation (4 weeks)
Sleep Quality
Time frame: Change in fatigue levels between start and end of prehabilitation (4 weeks)
Fatigue Levels
Time frame: Change in well-being scores between start and end of prehabilitation (4 weeks)
Sense of Well-being
Royal Surrey County Hospital NHS Foundation Trust
Other
A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection
Acronym: MedEx
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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