Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01329120
Status:
UNKNOWN
Last Update Posted:
2015-06-02
First Post:
2011-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short and Long-term Effects of Surgical Repair of Pectus Deformities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-31', 'studyFirstSubmitDate': '2011-04-04', 'studyFirstSubmitQcDate': '2011-04-04', 'lastUpdatePostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistent post-surgical pain', 'timeFrame': 'At least 4 months following surgery', 'description': 'Persistent post-surgical pain is in this study defined as pain developing after pectus surgery and lasting for at least 4 months. Other causes of pain (e.g. infection and malignancy) and pain continuing from a pre-existing pain problem will be excluded.\n\nPersistent post-surgical pain present at time of the study will be assessed by means of a specifically developed questionnaire including items from the Danish translation of the Brief Pain inventory (BPI-short form) and the Danish translation of the short version of the McGill Pain Questionnaire (SF-MPQ).'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life', 'timeFrame': 'At least 4 months following surgery', 'description': 'Health-related quality of life (HRQol) will be assessed by means of a validated Danish version of the Short-Form (36) Health Survey (SF-36)'}, {'measure': 'Patient satisfaction', 'timeFrame': 'At least 4 months following surgery', 'description': 'Satisfaction with the result of the deformity repair and the perceived impact of the correction on health-related quality of life is assessed by means of questions about the emotional and practical consequences of, and satisfaction with pectus repair.'}, {'measure': 'Aesthetic outcome', 'timeFrame': 'At least 4 months following surgery', 'description': 'In order to assess the surgical outcome following pectus repair in terms of aesthetic outcome more objectively, patients are encouraged to upload or e-mail a digital frontal image of their chests. Two thoracic surgeons, including the operating surgeon, and a research secretary are instructed to evaluate the breast symmetry, scars on the chest, and the overall cosmetic result of the repair.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'A large number of institutions have reported their early results with minimally invasive repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed the outcomes relevant to the concerns of the patients and even fewer have reported long-term results following bar removal. Even fewer studies have investigated the prevalence and characteristics of long term persistent post-surgical pain following surgical repair of pectus deformities. The reasons as to why acute postoperative pain in some patients persists and becomes chronic whereas in others the pain dies down shortly after wound healing are largely unknown, and why some patients complain of loss of sensibility in wide regions of their chest following surgery also remains unclear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby for the purpose of pectus deformity repair from January 1, 2001 to December 31, 2010 are invited to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimally invasive repair of pectus excavatum from 2001 throughout 2010.\n* Open surgical repair of pectus carinatum from 2001 throughout 2010.\n\nExclusion Criteria:\n\n* Not being able to fill in detailed questionnaires in Danish'}, 'identificationModule': {'nctId': 'NCT01329120', 'briefTitle': 'Short and Long-term Effects of Surgical Repair of Pectus Deformities', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Short and Long-term Effects of Surgical Repair of Pectus Excavatum and Pectus Carinatum - A Questionnaire Study of Persistent Post-surgical Pain, Health-related Quality of Life, Patient Satisfaction, and Aesthetic Outcome', 'orgStudyIdInfo': {'id': 'MIRPEX-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pectus excavatum', 'description': 'Patients who has undergone minimally invasive repair of pectus excavatum', 'interventionNames': ['Procedure: Minimally invasive repair of pectus excavatum']}, {'label': 'Pectus carinatum', 'description': 'Patients who has undergone open surgical repair of pectus carinatum', 'interventionNames': ['Procedure: Open surgical repair of pectus carinatum']}], 'interventions': [{'name': 'Minimally invasive repair of pectus excavatum', 'type': 'PROCEDURE', 'otherNames': ['Nuss procedure'], 'description': 'Minimally invasive surgical technique basically consisting of inserting one or more convex steel bars under the sternum through small bilateral incisions in the thoracic wall', 'armGroupLabels': ['Pectus excavatum']}, {'name': 'Open surgical repair of pectus carinatum', 'type': 'PROCEDURE', 'otherNames': ['Ravitch procedure'], 'description': 'Open surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum', 'armGroupLabels': ['Pectus carinatum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'contacts': [{'name': 'Kasper Grosen, PhD Fellow', 'role': 'CONTACT', 'email': 'kasper.grosen@ki.au.dk', 'phone': '+4589495443'}, {'name': 'Hans K Pilegaard, MD', 'role': 'CONTACT', 'email': 'pilegaard@dadlnet.dk', 'phone': '+4589495403'}, {'name': 'Kasper Grosen, PhD Fellow', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vascular Surgery', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Kasper Grosen, PhD Fellow', 'role': 'CONTACT', 'email': 'kasper.grosen@ki.au.dk', 'phone': '+4589495443'}, {'name': 'Hans K Pilegaard, MD', 'role': 'CONTACT', 'email': 'pilegaard@dadlnet.dk', 'phone': '+4589495403'}], 'overallOfficials': [{'name': 'Kasper Grosen, PhD Fellow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital Skejby'}, {'name': 'Hans K Pilegaard, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarhus University Hospital Skejby'}, {'name': 'Mogens Pfeiffer-Jensen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital, Aarhus Sygehus'}, {'name': 'Vibeke E Hjortdal, Prof., MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital Skejby'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}