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Enhancing Fitness Before Pancreatic Surgery (MedEx)

Primary Purpose

Pancreatic Cancer, Pancreatitis, Chronic

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MedEx
Sponsored by
Royal Surrey County Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pancreatic Cancer focused on measuring prehabilitation, pancreatectomy, nutrition, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MATTU, Royal Surrey County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MedEx

Standard Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Peak power - measured using cardiopulmonary exercise testing
cardiopulmonary fitness

Secondary Outcome Measures

Insulin sensitivity - measured using the insulin clamp test
insulin sensitivity
Length of stay
Recovery
Complication rate
Morbidity
Sleep
Sleep Quality
Fatigue
Fatigue Levels
Well-being
Sense of Well-being

Full Information

First Posted
October 15, 2016
Last Updated
August 28, 2018
Sponsor
Royal Surrey County Hospital NHS Foundation Trust
Collaborators
University of Surrey
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1. Study Identification

Unique Protocol Identification Number
NCT02940067
Brief Title
Enhancing Fitness Before Pancreatic Surgery
Acronym
MedEx
Official Title
A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
June 21, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Surrey County Hospital NHS Foundation Trust
Collaborators
University of Surrey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pancreatitis, Chronic
Keywords
prehabilitation, pancreatectomy, nutrition, exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MedEx
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
This group will follow current standard preoperative care before scheduled pancreatic resection.
Intervention Type
Other
Intervention Name(s)
MedEx
Other Intervention Name(s)
Prehabilitation
Intervention Description
A combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery
Primary Outcome Measure Information:
Title
Peak power - measured using cardiopulmonary exercise testing
Description
cardiopulmonary fitness
Time Frame
Change in peak power between start and end of prehabilitation (4 weeks)
Secondary Outcome Measure Information:
Title
Insulin sensitivity - measured using the insulin clamp test
Description
insulin sensitivity
Time Frame
Change in insulin sensitivity between start and end of prehabilitation (4 weeks)
Title
Length of stay
Description
Recovery
Time Frame
From date of operation until date of discharge
Title
Complication rate
Description
Morbidity
Time Frame
From date of operation until date of discharge
Title
Sleep
Description
Sleep Quality
Time Frame
Change in sleep quality between start and end of prehabilitation (4 weeks)
Title
Fatigue
Description
Fatigue Levels
Time Frame
Change in fatigue levels between start and end of prehabilitation (4 weeks)
Title
Well-being
Description
Sense of Well-being
Time Frame
Change in well-being scores between start and end of prehabilitation (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Rockall, MD FRCS
Organizational Affiliation
MATTU, Royal Surrey County Hospital, Guildford, Surrey
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mike Scott, FRCA FFICM
Organizational Affiliation
MATTU, Royal Surrey County Hospital, Guildford, Surrey
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jason George, MA MRCS
Organizational Affiliation
MATTU, Royal Surrey County Hospital, Guildford, Surrey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Whyte, PhD FRCP
Organizational Affiliation
University of Surrey, Guildford, Surrey
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joe Wainwright, BSc
Organizational Affiliation
University of Surrey and Surrey Human Performance Institute
Official's Role
Study Director
Facility Information:
Facility Name
MATTU, Royal Surrey County Hospital
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7WG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26864728
Citation
Dunne DF, Jack S, Jones RP, Jones L, Lythgoe DT, Malik HZ, Poston GJ, Palmer DH, Fenwick SW. Randomized clinical trial of prehabilitation before planned liver resection. Br J Surg. 2016 Apr;103(5):504-12. doi: 10.1002/bjs.10096. Epub 2016 Feb 11.
Results Reference
background
PubMed Identifier
20631016
Citation
Sato H, Carvalho G, Sato T, Lattermann R, Matsukawa T, Schricker T. The association of preoperative glycemic control, intraoperative insulin sensitivity, and outcomes after cardiac surgery. J Clin Endocrinol Metab. 2010 Sep;95(9):4338-44. doi: 10.1210/jc.2010-0135. Epub 2010 Jul 14.
Results Reference
background
PubMed Identifier
20134313
Citation
Snowden CP, Prentis JM, Anderson HL, Roberts DR, Randles D, Renton M, Manas DM. Submaximal cardiopulmonary exercise testing predicts complications and hospital length of stay in patients undergoing major elective surgery. Ann Surg. 2010 Mar;251(3):535-41. doi: 10.1097/SLA.0b013e3181cf811d.
Results Reference
background

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Enhancing Fitness Before Pancreatic Surgery

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