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临床试验/NCT02940067
NCT02940067已完成不适用

A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection

Royal Surrey County Hospital NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Peak power - measured using cardiopulmonary exercise testing

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective pancreatic resection

排除标准

  • 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

研究组 & 干预措施

MedEx

Experimental

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.

干预措施: MedEx (Other)

Standard Care

No Intervention

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

结局指标

主要结局

Peak power - measured using cardiopulmonary exercise testing

时间窗: Change in peak power between start and end of prehabilitation (4 weeks)

cardiopulmonary fitness

次要结局

  • Length of stay(From date of operation until date of discharge)
  • Sleep(Change in sleep quality between start and end of prehabilitation (4 weeks))
  • Fatigue(Change in fatigue levels between start and end of prehabilitation (4 weeks))
  • Insulin sensitivity - measured using the insulin clamp test(Change in insulin sensitivity between start and end of prehabilitation (4 weeks))
  • Complication rate(From date of operation until date of discharge)
  • Well-being(Change in well-being scores between start and end of prehabilitation (4 weeks))

研究者

发起方
Royal Surrey County Hospital NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason George

Research Fellow

Royal Surrey County Hospital NHS Foundation Trust

研究点 (2)

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