Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-04-23 @ 4:27 PM
Study NCT ID:
NCT05159505
Status:
UNKNOWN
Last Update Posted:
2021-12-16
First Post:
2021-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interdisciplinary Scoliosis Correction Program.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-02', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'type of complications', 'timeFrame': 'up to 4 weeks after surgery', 'description': 'surgery and anaesthesia complications'}], 'secondaryOutcomes': [{'measure': 'Postoperative length of hospital stay', 'timeFrame': 'up to 4 weeks after surgery', 'description': 'Postoperative length of hospital stay'}, {'measure': 'Number of Analgetics consumption', 'timeFrame': 'up to 6 days after surgery', 'description': 'consumption including opioids and non-opioids drug'}, {'measure': 'Time to first bowel motion', 'timeFrame': 'up to 6 days after surgery', 'description': 'Able to eat without abdominal discomfort, nausea, or vomiting'}, {'measure': 'Time to first verticalization', 'timeFrame': 'up to 6 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scoliosis Idiopathic', 'Scoliosis; Juvenile', 'Scoliosis', 'ERAS', 'Complication,Postoperative', 'Complication of Surgical Procedure']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the outcomes after scoliosis surgery before and after the implementation of an interdisciplinary juvenile scoliosis correction program in teenager based on ERAS (enhanced recovery after surgery) principles.', 'detailedDescription': 'Creating an optimal protocol for interdisciplinary care in the perioperative period in terms of therapeutic management (anesthesia and surgery schedule), as well as care, rehabilitation and ensuring mental well-being determines the real impact on the reduction of the risk of complications in the perioperative period. Enhanced recovery after surgery (ERAS) protocol has been found to result in reduced lenght of stay and complications in adult patients. Data in pediatric population remains modest. In addition to ERAS principles our terapeutic team has created a special educational application for better patient preparation for surgery. The purpose of the application is to explain the general rules of conduct in the process of preparing and carrying out surgery, anesthesia, prehabilitation and physiotherapy in children undergoing orthopedics surgery (e.g. spine surgery for adolescent idiopathic scoliosis).\n\nHypothesis: Implementing an interdisciplinary juvenile scoliosis correction program based on ERAS principles and special educational app. will improve patient outcomes leading to a statistically significant reduction in post-operative pain and opioids demand, complication rate, length of stay without increasing readmissions and cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Caucasian children undergoing orthopedics surgery (e.g. spine surgery for adolescent idiopathic scoliosis).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with age \\< 18 years\n* patient scheduled for idiopatic scoliosis surgery\n\nExclusion Criteria:\n\n* patient with age \\> 18years others type of scoliosis'}, 'identificationModule': {'nctId': 'NCT05159505', 'briefTitle': 'Interdisciplinary Scoliosis Correction Program.', 'organization': {'class': 'OTHER', 'fullName': 'Pomeranian Medical University Szczecin'}, 'officialTitle': 'Strategies for the Implementation of an Interdisciplinary Juvenile Scoliosis Correction Program Based on ERAS Principles. Before-after Study.', 'orgStudyIdInfo': {'id': 'KB-0012/126/10/2021/Z'}}, 'armsInterventionsModule': {'armGroups': [{'label': '"the before" group', 'description': '40 teenagers after scoliosis surgery before interdisciplinary program implementation'}, {'label': '"the after" group 1', 'description': '40 teenagers after scoliosis surgery after ERAS program implementation'}, {'label': '"the after" group 2', 'description': '40 teenagers after scoliosis surgery after ERAS and educational program implementation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70-204', 'city': 'Szczecin', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jowita Biernawska, MD PhD', 'role': 'CONTACT', 'email': 'lisienko@wp.pl', 'phone': '+48501337073'}], 'facility': 'Pomeranian Medical University', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}], 'centralContacts': [{'name': 'Jowita Biernawska, MD PhD', 'role': 'CONTACT', 'email': 'lisienko@wp.pl', 'phone': '501337073'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'nd'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pomeranian Medical University Szczecin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Jowita Biernawska', 'investigatorAffiliation': 'Pomeranian Medical University Szczecin'}}}}