Enhancing Fitness Before Pancreatic Surgery

NCT02940067 | Completed DMC

• 1 other identifier: 197169
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer; Pancreatitis, Chronic

Keywords

prehabilitation; pancreatectomy; nutrition; exercise

Outcome Measures

Primary Outcomes (1)

• Peak power - measured using cardiopulmonary exercise testing

  cardiopulmonary fitness

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

Secondary Outcomes (6)

• Insulin sensitivity - measured using the insulin clamp test

  Change in insulin sensitivity between start and end of prehabilitation (4 weeks)

• Length of stay

  From date of operation until date of discharge

• Complication rate

  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)

Study Arms (2)

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.

Other: MedEx

Standard Care

NO INTERVENTION

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

Interventions

MedEx OTHER

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

Also known as: Prehabilitation

MedEx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective pancreatic resection

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead
• University of Surrey: collaborator

Study Sites (1)

MATTU, Royal Surrey County Hospital

Guildford, Surrey, GU2 7WG, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 26864728 BACKGROUND

• 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.

  PMID: 20631016 BACKGROUND

• 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.

  PMID: 20134313 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis, Chronic; Motor Activity

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Tim Rockall, MD FRCS

  MATTU, Royal Surrey County Hospital, Guildford, Surrey

  STUDY CHAIR

• Mike Scott, FRCA FFICM

  MATTU, Royal Surrey County Hospital, Guildford, Surrey

  STUDY DIRECTOR

• Jason George, MA MRCS

  MATTU, Royal Surrey County Hospital, Guildford, Surrey

  PRINCIPAL INVESTIGATOR

• Martin Whyte, PhD FRCP

  University of Surrey, Guildford, Surrey

  STUDY DIRECTOR

• Joe Wainwright, BSc

  University of Surrey and Surrey Human Performance Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: October 15, 2016
• First Posted: October 20, 2016
• Study Start: March 28, 2017
• Primary Completion: June 21, 2018
• Study Completion: August 20, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)