Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT05851833
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2023-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Retrospective Study of Early Postoperative Mobilization in the Recovery of Patients With Oral Head and Neck Tumors Who Underwent Flap Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004434', 'term': 'Early Ambulation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-01', 'studyFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2023-05-01', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay after surgery', 'timeFrame': 'February 2020 to July 2021', 'description': 'The time span between the end of surgery and hospital discharge is defined as the length of hospital stay after surgery.'}], 'secondaryOutcomes': [{'measure': 'pulmonary infection rate', 'timeFrame': 'February 2020 to July 2021', 'description': 'The pulmonary infection rate is calculated as the proportion of hospitalized patients who had pulmonary infections over all patients.'}, {'measure': 'deep vein thrombosis rate', 'timeFrame': 'February 2020 to July 2021', 'description': 'The deep vein thrombosis rate is calculated as the proportion of hospitalized patients who had deep vein thrombosis over all patients.'}, {'measure': 'flap crisis rate', 'timeFrame': 'February 2020 to July 2021', 'description': 'The flap crisis rate is calculated as the proportion of hospitalized patients who had flap crisis over all patients.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Length of Hospital Stay']}, 'descriptionModule': {'briefSummary': "All patients with head and neck cancers and osteomyelitis who underwent vascularized flap reconstruction at Shanghai Ninth People's Hospital (North Campus), Shanghai Jiao Tong University, from February 2020 to July 2021 were the object of a retrospective data collection.Depending on whether they had postoperative early mobilization, all patients were split into experimental and control groups.In the experimental group, patients were split into two groups based on the postoperative day(POD): the POD 0-1 group and the POD \\>1 group.Comparison and analysis were done on the difference in hospital days and post-operative complication rates between the two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Early Mobilizationon Recovery After Major Head and Neck Surgery With Flap Reconstruction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with head and neck diseases undergoing flap reconstruction and repair\n2. Patients with complete data preservation and consent\n3. Patients who follow medical advice during hospitalization\n\nExclusion Criteria:\n\n1. Patients who survived less than 1 month after surgery\n2. Patients with other tumors before surgery 3, mental patients, audio-visual impairment or uncooperative patients'}, 'identificationModule': {'nctId': 'NCT05851833', 'briefTitle': 'A Retrospective Study of Early Postoperative Mobilization in the Recovery of Patients With Oral Head and Neck Tumors Who Underwent Flap Reconstruction', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}, 'officialTitle': 'A Retrospective Study of Early Postoperative Mobilization in the Recovery of Patients With Oral Head and Neck Tumors Who Underwent Flap Reconstruction', 'orgStudyIdInfo': {'id': '654321'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early MobilizatioN', 'interventionNames': ['Behavioral: Early Mobilization']}, {'label': 'conventional Mobilization'}], 'interventions': [{'name': 'Early Mobilization', 'type': 'BEHAVIORAL', 'description': 'The time the patient began to sit, stand, and walk after surgery is earlier than traditional model.', 'armGroupLabels': ['Early MobilizatioN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Ninth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jie He, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate chief physician', 'investigatorFullName': 'Jie He, MD', 'investigatorAffiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}}}}