Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT03466593
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2018-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Prehabilitation and Early Mobilization for Patients Undergoing Pancreas Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], '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'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. A prospective cohort compared to historical controls\n2. A randomized, controlled, intervention study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'Whole study period from inclusion to one year after surgery', 'description': 'Standardized complications according to register'}, {'measure': 'PaO2', 'timeFrame': 'The day before surgery to the first day after surgery', 'description': 'Arterial oxygen pressure'}], 'secondaryOutcomes': [{'measure': 'EORTC-module generic', 'timeFrame': 'Whole study period from inclusion to one year after surgery', 'description': 'Quality of life, EORTC-QLQ-C30 (Range 30-124) Low values correspond to high quality of life'}, {'measure': 'EORTC-module specific for pancreas cancer', 'timeFrame': 'Whole study period from inclusion to one year after surgery', 'description': 'Quality of life QLQ-OG25 (Range 25- 100). Low values correspond to high quality of life'}, {'measure': 'EORTC-module for fatigue', 'timeFrame': 'Whole study period from inclusion to one year after surgery', 'description': 'Quality of Life FA-R13 (range 12- 48). Low values correspond to high quality of life'}, {'measure': 'The Postoperative Recovery Profile', 'timeFrame': 'Whole study period from inclusion to one year after surgery', 'description': 'Quality of recovery according to Allvin et al. 19 statements which are rated on a four grade scale fron no problem to major problem'}, {'measure': 'Pancreatic cancer disease impact (PACADI) score', 'timeFrame': 'Whole study period from inclusion to one year after surgery', 'description': 'Disease specific questionnaire, 8 statements rated on a visual analogue scale from 0 (no problem) to 10 (worst imaginable problem). Sum score are used for analysis (Range 0-80)'}, {'measure': 'Spirometry', 'timeFrame': 'From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation', 'description': 'Vital capacity'}, {'measure': 'Lenght of stay', 'timeFrame': 'From the day before surgery to discharge from the hospital (app 7-14 days)', 'description': 'Length of stay at the hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehabilitation', 'Recovery', 'Complications'], 'conditions': ['Pancreas Cancer']}, 'referencesModule': {'references': [{'pmid': '33827537', 'type': 'DERIVED', 'citation': 'Fagevik Olsen M, Becovic S, Dean E. Short-term effects of mobilization on oxygenation in patients after open surgery for pancreatic cancer: a randomized controlled trial. BMC Surg. 2021 Apr 7;21(1):185. doi: 10.1186/s12893-021-01187-2.'}]}, 'descriptionModule': {'briefSummary': "Open upper gastrointestinal surgery includes surgery in the upper abdomen such as ventricular, duodenal, pancreatic and biliary tract surgery. After upper abdominal surgery there is a risk of gastrointestinal and cardiopulmonary complications. There is currently insufficient knowledge about the effect of prehabilitation and extra early postoperative mobilization in upper pancreatic surgery.\n\nThis study's aim is to evaluate the effect of prehabilitation and extra early mobilization.\n\nThe study includes two substudies:\n\n1. A prospective cohort of 75 patients undergoing pancreatic surgery after a prehabilitation program will be compared to 75 historical controls. Primary outcome is postoperative complications.\n2. A randomized controlled trial based on 72 patients undergoing pancreatic studying the effect of extra early rehabilitation. The intervention group will be mobilized to bedside, standing or sitting in armchair \\<6 hours after surgery, ie 3-4 hours after arrival at the Postoperative Department (PIVA). The control group will be mobilized according to routine i.e. the morning after surgery. Primary outcome is PaO2."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to undergo pancreatic surgery\n\nExclusion Criteria in substudy b:\n\n* Preoperative injury or disease making it impossible to perform the intervention'}, 'identificationModule': {'nctId': 'NCT03466593', 'acronym': 'PreMob', 'briefTitle': 'Effects of Prehabilitation and Early Mobilization for Patients Undergoing Pancreas Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Effekt av Prehabilitering Och Extra Tidig Mobilisering Efter öppen Pankreas Kirurgi', 'orgStudyIdInfo': {'id': 'FoU i VGR: 238701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prospective cohort-prehabilitation', 'description': 'A prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol.', 'interventionNames': ['Other: Prehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Retrospective cohort', 'description': 'Routine care before the prehabilitation program was introduced', 'interventionNames': ['Other: Routine care']}, {'type': 'EXPERIMENTAL', 'label': 'Extra early mobilization', 'description': 'Mobilization the day of surgery', 'interventionNames': ['Other: Extra early mobilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional mobilization', 'description': 'Routine care with mobilization the day after surgery', 'interventionNames': ['Other: Standard mobilization']}], 'interventions': [{'name': 'Prehabilitation', 'type': 'OTHER', 'description': 'Prehabilitation concerning eating, smoking, drinking and physical activity', 'armGroupLabels': ['Prospective cohort-prehabilitation']}, {'name': 'Routine care', 'type': 'OTHER', 'description': 'Preoperative information', 'armGroupLabels': ['Retrospective cohort']}, {'name': 'Extra early mobilization', 'type': 'OTHER', 'description': 'Mobilization the day of surgery', 'armGroupLabels': ['Extra early mobilization']}, {'name': 'Standard mobilization', 'type': 'OTHER', 'description': 'Mobilization the day after surgery', 'armGroupLabels': ['Traditional mobilization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Göteborg University', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}