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Enhancing Fitness Before Pancreatic Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02940067
Acronym
MedEx
Enrollment
20
Registered
2016-10-20
Start date
2017-03-28
Completion date
2018-08-20
Last updated
2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer, Pancreatitis, Chronic

Keywords

prehabilitation, pancreatectomy, nutrition, exercise

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.

Interventions

OTHERMedEx

A combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery

Sponsors

University of Surrey
CollaboratorOTHER
Royal Surrey County Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Peak power - measured using cardiopulmonary exercise testingChange in peak power between start and end of prehabilitation (4 weeks)cardiopulmonary fitness

Secondary

MeasureTime frameDescription
Length of stayFrom date of operation until date of dischargeRecovery
Complication rateFrom date of operation until date of dischargeMorbidity
Insulin sensitivity - measured using the insulin clamp testChange in insulin sensitivity between start and end of prehabilitation (4 weeks)insulin sensitivity
FatigueChange in fatigue levels between start and end of prehabilitation (4 weeks)Fatigue Levels
Well-beingChange in well-being scores between start and end of prehabilitation (4 weeks)Sense of Well-being
SleepChange in sleep quality between start and end of prehabilitation (4 weeks)Sleep Quality

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026