Enhancing Fitness Before Pancreatic Surgery

Not Applicable

Completed

• Conditions: Pancreatitis, Chronic; Pancreatic Cancer
• Interventions: Other: MedEx

• Registration Number: NCT02940067
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2016-10-15
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-20
• Study Start: 2017-03-28
• Primary Completion: 2018-06-21
• Status Verified: 2018-08
• Study Completion: 2018-08-20
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MedEx	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.

Primary Outcome Measures

Name	Time	Method
Peak power - measured using cardiopulmonary exercise testing	Change in peak power between start and end of prehabilitation (4 weeks)	cardiopulmonary fitness

Secondary Outcome Measures

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

Trial Locations

Locations (1)

MATTU, Royal Surrey County Hospital; 🇬🇧 Guildford, Surrey, United Kingdom