Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT03100669
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2017-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program Via Tele-monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], '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'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'targetDuration': '10 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-03', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rosenberg self-esteem questionnaire', 'timeFrame': 'Allowed period for fill in: from two weeks before planned surgery until day before planned surgery', 'description': 'Preoperative evaluation of self-esteem by the Rosenberg self-esteem questionnaire, via a patient specific online platform'}, {'measure': 'Hospital anxiety and depression scale (HAD)', 'timeFrame': 'Allowed period for fill in: from two weeks before planned surgery until day before planned surgery', 'description': 'Preoperative evaluation of anxiety and depression by the HAD questionnaire, via a patient specific online platform'}, {'measure': 'State-Trait anxiety Inventory (STAI)', 'timeFrame': 'Allowed period for fill in: from two weeks before planned surgery until day before planned surgery', 'description': 'Preoperative evaluation of state and trait characteristics by the STAI questionnaire, via a patient specific online platform'}, {'measure': 'Multidisciplinary Pain Inventory (MPI)', 'timeFrame': 'Allowed period for fill in: first two weeks after hospital discharge', 'description': 'Postoperative evaluation of pain severity and interference by the MPI questionnaire, via a patient specific online platform'}, {'measure': 'Coping Pain Questionnaire (CPQ)', 'timeFrame': 'Allowed period for fill in: first two weeks after hospital discharge', 'description': 'Postoperative evaluation of coping strategy (active, passive, self-efficacy) by the CPQ questionnaire, via a patient specific online platform'}], 'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '10 weeks after surgery', 'description': 'pain registration via numeric rating scale during hospitalization up to 10 weeks after surgery'}], 'secondaryOutcomes': [{'measure': 'Sleep', 'timeFrame': '2 weeks before up to 10 weeks after surgery', 'description': 'hours of sleep up to 10 weeks after surgery'}, {'measure': 'Daily activity', 'timeFrame': '2 weeks before up to 10 weeks after surgery', 'description': 'daily activity via scale (0: no activity and 10 maximum of activities) and activity tracker device during hospitalization up to 10 weeks after surgery'}, {'measure': 'Nausea', 'timeFrame': 'From day of surgery until hospital discharge (approximately 7 days)', 'description': 'registration of nausea and vomiting by questionnaire during hospitalization period'}, {'measure': 'Mobility', 'timeFrame': 'From day of surgery until hospital discharge (approximately 7 days)', 'description': 'Daily mobility assessment by attending physiotherapist via scale (1: exercises in bed, 2: exercises while sitting, 3: exercises while standing, 4: exercises while walking) during hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Postoperative Nausea']}, 'referencesModule': {'references': [{'pmid': '33401363', 'type': 'DERIVED', 'citation': "Wildemeersch D, D'Hondt M, Bernaerts L, Mertens P, Saldien V, Hendriks JM, Walcarius AS, Sterkens L, Hans GH. Implementation of an Enhanced Recovery Pathway for Minimally Invasive Pectus Surgery: A Population-Based Cohort Study Evaluating Short- and Long-Term Outcomes Using eHealth Technology. JMIR Perioper Med. 2018 Oct 12;1(2):e10996. doi: 10.2196/10996."}, {'pmid': '29853436', 'type': 'DERIVED', 'citation': "Wildemeersch D, Bernaerts L, D'Hondt M, Hans G. Preliminary Evaluation of a Web-Based Psychological Screening Tool in Adolescents Undergoing Minimally Invasive Pectus Surgery: Single-Center Observational Cohort Study. JMIR Ment Health. 2018 May 31;5(2):e45. doi: 10.2196/mental.9806."}]}, 'descriptionModule': {'briefSummary': 'MIRP (Minimally Invasive Repair of Pectus) as surgical correction of pectus excavatum or carinatum is performed to achieve physiological, cosmetic, and psychological benefits for the patient. Surgery is often associated with severe postoperative pain. In this study the researchers want to registrate pain, sleep, nausea/vomiting, and daily activities in short and long term follow up.', 'detailedDescription': 'In order to provide pain patients with an individualized approach to their pain problem after MIRP we developed an electronic medical record coupled to a set of telemetric medical-grade devices. Appi@Home (Antwerp Personalized Pain Initiative) supports an innovative approach to (sub)acute conditions by offering a platform for continuous follow-up. Patients are provided with a toolbox and an app that continuously collects objective outcome data (i.e. pain intensity, sleep quality, physical activity). The integrated system allows the care givers to respond very quickly to changing clinical conditions of the patient, making a very adaptive and individualized follow-up possible for these patients. In addition, the patient becomes an active participant in the global therapeutic approach.\n\nPatients receive the toolbox two week prior to surgery with access to the internet platform for questionnaires fill-in procedure. Up to ten week after surgery pain intensity, sleep quality and physical activity will be monitored subjectively by a scoring table (0-10, 0 no pain-bad sleeping quality-no activity, 10 maximum of pain-excellent sleeping quality- a lot of activity) and objectively by blood pressure device, oxygen saturation monitoring, activity tracker and sleep registration tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients planned for elective pectus surgery are asked for study inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective pectus repair\n* signed informed consent\n\nExclusion Criteria:\n\n* chronic opioid use (\\> 3 months)\n* history of ongoing psychiatric disease'}, 'identificationModule': {'nctId': 'NCT03100669', 'briefTitle': 'Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program Via Tele-monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program: Short and Long-term Evaluation of Pain, Nausea, Sleep, and Rehabilitation Via Tele-monitoring', 'orgStudyIdInfo': {'id': '17/08/082'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pectus surgery', 'description': 'Single arm study: patient undergoing pectus repair surgery', 'interventionNames': ['Procedure: Pectus surgery']}], 'interventions': [{'name': 'Pectus surgery', 'type': 'PROCEDURE', 'description': 'Patients undergoing surgical repair of pectus excavatum or carinatum', 'armGroupLabels': ['Pectus surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'University hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universiteit Antwerpen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident anesthesiology', 'investigatorFullName': 'Davina Wildemeersch', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}