Clinical trial NCT02940067: Enhancing Fitness Before Pancreatic Surgery
Official title: A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Pancreatitis, Chronic
Keywords: prehabilitation
pancreatectomy
nutrition
exercise
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Surrey
First posted: 2016-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Peak power - measured using cardiopulmonary exercise testing
timeFrame: Change in peak power between start and end of prehabilitation (4 weeks)
Secondary outcomes:
measure: Insulin sensitivity - measured using the insulin clamp test
timeFrame: Change in insulin sensitivity between start and end of prehabilitation (4 weeks)
measure: Length of stay
timeFrame: From date of operation until date of discharge
measure: Complication rate
timeFrame: From date of operation until date of discharge
measure: Sleep
timeFrame: Change in sleep quality between start and end of prehabilitation (4 weeks)
measure: Fatigue
timeFrame: Change in fatigue levels between start and end of prehabilitation (4 weeks)
measure: Well-being
timeFrame: Change in well-being scores between start and end of prehabilitation (4 weeks)
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: MATTU, Royal Surrey County Hospital
state: Surrey
Study officials:
affiliation: MATTU, Royal Surrey County Hospital, Guildford, Surrey
name: Tim Rockall, MD FRCS
role: STUDY_CHAIR
affiliation: MATTU, Royal Surrey County Hospital, Guildford, Surrey
name: Mike Scott, FRCA FFICM
role: STUDY_DIRECTOR
affiliation: MATTU, Royal Surrey County Hospital, Guildford, Surrey
name: Jason George, MA MRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Surrey, Guildford, Surrey
name: Martin Whyte, PhD FRCP
role: STUDY_DIRECTOR
affiliation: University of Surrey and Surrey Human Performance Institute
name: Joe Wainwright, BSc
role: STUDY_DIRECTOR
References:
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.
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.
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.