Enhancing Fitness Before Pancreatic Surgery (MedEx)
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|ClinicalTrials.gov Identifier: NCT02940067|
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Pancreatitis, Chronic||Other: MedEx||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection|
|Actual Study Start Date :||March 28, 2017|
|Actual Primary Completion Date :||June 21, 2018|
|Actual Study Completion Date :||August 20, 2018|
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.
A combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery
Other Name: Prehabilitation
No Intervention: Standard Care
This group will follow current standard preoperative care before scheduled pancreatic resection.
- Peak power - measured using cardiopulmonary exercise testing [ Time Frame: Change in peak power between start and end of prehabilitation (4 weeks) ]cardiopulmonary fitness
- Insulin sensitivity - measured using the insulin clamp test [ Time Frame: Change in insulin sensitivity between start and end of prehabilitation (4 weeks) ]insulin sensitivity
- Length of stay [ Time Frame: From date of operation until date of discharge ]Recovery
- Complication rate [ Time Frame: From date of operation until date of discharge ]Morbidity
- Sleep [ Time Frame: Change in sleep quality between start and end of prehabilitation (4 weeks) ]Sleep Quality
- Fatigue [ Time Frame: Change in fatigue levels between start and end of prehabilitation (4 weeks) ]Fatigue Levels
- Well-being [ Time Frame: Change in well-being scores between start and end of prehabilitation (4 weeks) ]Sense of Well-being
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940067
|MATTU, Royal Surrey County Hospital|
|Guildford, Surrey, United Kingdom, GU2 7WG|
|Study Chair:||Tim Rockall, MD FRCS||MATTU, Royal Surrey County Hospital, Guildford, Surrey|
|Study Director:||Mike Scott, FRCA FFICM||MATTU, Royal Surrey County Hospital, Guildford, Surrey|
|Principal Investigator:||Jason George, MA MRCS||MATTU, Royal Surrey County Hospital, Guildford, Surrey|
|Study Director:||Martin Whyte, PhD FRCP||University of Surrey, Guildford, Surrey|
|Study Director:||Joe Wainwright, BSc||University of Surrey and Surrey Human Performance Institute|