Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-29 @ 12:22 PM
Study NCT ID:
NCT02940067
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2016-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Fitness Before Pancreatic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2016-10-15', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak power - measured using cardiopulmonary exercise testing', 'timeFrame': 'Change in peak power between start and end of prehabilitation (4 weeks)', 'description': 'cardiopulmonary fitness'}], 'secondaryOutcomes': [{'measure': 'Insulin sensitivity - measured using the insulin clamp test', 'timeFrame': 'Change in insulin sensitivity between start and end of prehabilitation (4 weeks)', 'description': 'insulin sensitivity'}, {'measure': 'Length of stay', 'timeFrame': 'From date of operation until date of discharge', 'description': 'Recovery'}, {'measure': 'Complication rate', 'timeFrame': 'From date of operation until date of discharge', 'description': 'Morbidity'}, {'measure': 'Sleep', 'timeFrame': 'Change in sleep quality between start and end of prehabilitation (4 weeks)', 'description': 'Sleep Quality'}, {'measure': 'Fatigue', 'timeFrame': 'Change in fatigue levels between start and end of prehabilitation (4 weeks)', 'description': 'Fatigue Levels'}, {'measure': 'Well-being', 'timeFrame': 'Change in well-being scores between start and end of prehabilitation (4 weeks)', 'description': 'Sense of Well-being'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prehabilitation', 'pancreatectomy', 'nutrition', 'exercise'], 'conditions': ['Pancreatic Cancer', 'Pancreatitis, Chronic']}, 'referencesModule': {'references': [{'pmid': '26864728', 'type': 'BACKGROUND', '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.'}, {'pmid': '20631016', 'type': 'BACKGROUND', '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.'}, {'pmid': '20134313', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study to investigate the effect of prehabilitation on patients undergoing elective surgery for pancreatic disease.', 'detailedDescription': "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.\n\nPatients 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nElective pancreatic resection\n\nExclusion Criteria:\n\nContraindication 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'}, 'identificationModule': {'nctId': 'NCT02940067', 'acronym': 'MedEx', 'briefTitle': 'Enhancing Fitness Before Pancreatic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Royal Surrey County Hospital NHS Foundation Trust'}, 'officialTitle': 'A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection', 'orgStudyIdInfo': {'id': '197169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MedEx', '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.', 'interventionNames': ['Other: MedEx']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'This group will follow current standard preoperative care before scheduled pancreatic resection.'}], 'interventions': [{'name': 'MedEx', 'type': 'OTHER', 'otherNames': ['Prehabilitation'], 'description': 'A combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery', 'armGroupLabels': ['MedEx']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU2 7WG', 'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'MATTU, Royal Surrey County Hospital', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'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': 'MATTU, Royal Surrey County Hospital, Guildford, Surrey'}, {'name': 'Martin Whyte, PhD FRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Surrey, Guildford, Surrey'}, {'name': 'Joe Wainwright, BSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Surrey and Surrey Human Performance Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Surrey County Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Surrey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Jason George', 'investigatorAffiliation': 'Royal Surrey County Hospital NHS Foundation Trust'}}}}