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2017-03-28
2018-06-21
2018-08-20
20
NCT02940067
Royal Surrey County Hospital NHS Foundation Trust
Royal Surrey County Hospital NHS Foundation Trust
INTERVENTIONAL
Enhancing Fitness Before Pancreatic Surgery
This is a pilot study to investigate the effect of prehabilitation on patients undergoing elective surgery for pancreatic disease.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-10-15 | N/A | 2018-08-28 |
2016-10-18 | N/A | 2018-08-29 |
2016-10-20 | N/A | 2018-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: MedEx 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
|
| NO_INTERVENTION: Standard Care This group will follow current standard preoperative care before scheduled pancreatic resection. |
| Primary Outcome Measures | 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 | 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) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
