Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-11 @ 5:25 PM
Study NCT ID:
NCT02658318
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Complications After Cleft Palate Closure in Patients With Pierre Robin Sequence: Operative Considerations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010855', 'term': 'Pierre Robin Syndrome'}, {'id': 'D002972', 'term': 'Cleft Palate'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D000402', 'term': 'Airway Obstruction'}], 'ancestors': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-15', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-01-15', 'lastUpdatePostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of peri- and postoperative complications', 'timeFrame': 'within 4 weeks postoperative'}], 'secondaryOutcomes': [{'measure': 'Identification of potential risk factors (demographic, diagnostic, surgical) for development of postoperative complications, through regression analysis', 'timeFrame': 'within 4 weeks postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peri- and postoperative complications', 'airway obstruction', 'adapted Furlow palatoplasty'], 'conditions': ['Pierre Robin Syndrome', 'Cleft Palate']}, 'descriptionModule': {'briefSummary': 'In cleft surgery there is no current general agreement on the treatment strategy of patients with the Pierre Robin Sequence. The timing of surgery and the surgical approach depends on the treating physician or the hospital facility. Literature regarding peri- and postoperative complications in the target population are lacking.\n\nThe investigators aim to retrospectively review the charts of all cleft patients, both PRS and non-PRS, treated with an adapted Furlow palatoplasty between 01/01/2011 and 31/08/2015. The incidence of peri- and postoperative complications, with a specific focus on respiratory complications, will be examined. The value of demographic, surgical and postoperative parameters will be examined as potential risk factors for the development of complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All cleft patients consecutively treated with a modified Furlow palatoplasty between 01/01/2011 and 31/08/2015 in the Department of Oral and Maxillofacial Surgery of the General Hospital Saint-John Bruges (Bruges, Belgium) or the Department of Pediatrics of the Semmelweis University (Budapest, Hungary)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of all ages\n* patients that had undergone a modified Furlow palatoplasty\n* patients treated at the GH Saint-John Bruges (Belgium), or the cooperating Semmelweis University (Hungary)\n\nExclusion Criteria:\n\n* patients not eligible according to the abovementioned criteria'}, 'identificationModule': {'nctId': 'NCT02658318', 'briefTitle': 'Postoperative Complications After Cleft Palate Closure in Patients With Pierre Robin Sequence: Operative Considerations', 'organization': {'class': 'OTHER', 'fullName': 'AZ Sint-Jan AV'}, 'orgStudyIdInfo': {'id': 'B049201525560'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pierre Robin Syndrome (PRS)', 'description': 'Cleft palate patients with the Pierre Robin Syndrome.'}, {'label': 'non-PRS', 'description': 'Cleft palate patients without the Pierre Robin Syndrome.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bruges', 'country': 'Belgium', 'facility': 'General Hospital Saint-John Bruges', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}], 'overallOfficials': [{'name': 'Johan Abeloos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maxillofacial surgeon, Head of Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Maxillofacial surgeon, Head of Department', 'investigatorFullName': 'Johan Abeloos', 'investigatorAffiliation': 'AZ Sint-Jan AV'}}}}