Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:59 AM
Study NCT ID:
NCT07465861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002559', 'term': 'Cerebrospinal Fluid Rhinorrhea'}], 'ancestors': [{'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086722', 'term': 'Rhinorrhea'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001510', 'term': 'Bed Rest'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 316}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-01-03', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skull base reconstruction success rate', 'timeFrame': 'within 1 month postoperatively'}], 'secondaryOutcomes': [{'measure': 'Postoperative quality-of-life score', 'timeFrame': 'low-flow group: postoperative day 2; high-flow group: postoperative day 4.', 'description': 'quality-of-life score is measured by Postoperative Recovery Scale for Adult (total score: 0-1000; higher is better)'}, {'measure': 'Incidence of venous thromboembolism', 'timeFrame': 'from postoperative day 1 to 14'}, {'measure': 'Incidence of pulmonary infection', 'timeFrame': 'from postoperative day 1 to 14'}, {'measure': 'Incidence of pressure ulcers', 'timeFrame': 'from postoperative day 1 to 14'}, {'measure': 'Postoperative length of stay', 'timeFrame': 'from postoperative day 1 to 30', 'description': 'stay duration in days'}, {'measure': 'Postoperative treatment cost', 'timeFrame': 'from postoperative day 1 to 30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bed rest', 'Endoscopic surgery', 'Cerebrospinal fluid rhinorrhea'], 'conditions': ['Skull Base']}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial conducted across multiple centers. Due to the anatomical and pathological complexity of endoscopic endonasal skull base surgery, the study scope was restricted to the midline anterior skull base region to maximize homogeneity among enrolled cases.\n\nAfter screening according to inclusion and exclusion criteria and obtaining informed consent, patients were intraoperatively classified into low-flow cerebrospinal fluid (CSF) leak (dural defect ≤1 cm²) or high-flow CSF leak (dural defect \\>1 cm²) groups. Patients in the low-flow group were randomly assigned to either a non-bed-rest group or a 2-day bed-rest group, while those in the high-flow group were randomly assigned to either a 1-day or a 3-day bed-rest group.\n\nThe primary outcome was the reconstruction success rate (from immediately postoperative to 1 month) compared between different bed-rest durations within the low-flow and high-flow subgroups, respectively. Secondary outcomes included the incidence of bed-rest-related postoperative adverse events during hospitalization (safety indicator), postoperative quality-of-life scores (functional indicator), length of postoperative hospital stay (days), and total treatment cost (healthcare resource utilization indicator).\n\nBy comparing these outcomes across groups, the study aims to evaluate the impact of bed-rest duration on the outcomes of endoscopic endonasal reconstruction of the midline anterior skull base, thereby providing high-quality clinical evidence to facilitate accelerated postoperative recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female patients aged 18-75 years.\n2. Scheduled to undergo endoscopic endonasal midline anterior skull-base surgery with an anticipated risk of intraoperative cerebrospinal fluid leak.\n3. Pre-operatively alert, with normal limb mobility, able to comply with both post-operative bed-rest and non-bed-rest protocols.\n4. Absence of severe cardiopulmonary dysfunction or any other comorbidity that would compromise tolerance of general anesthesia or surgical intervention.\n5. Good patient compliance, voluntary participation in this clinical study, and signed informed consent.\n\nExclusion Criteria:\n\n1. Pre-existing bed-rest-related complications such as hypostatic pneumonia, lower-extremity venous thrombosis, or pressure ulcers.\n2. Anticipated requirement for prolonged post-operative bed rest.\n3. No cerebrospinal fluid leakage occurred during surgery, or dural defect extending beyond the midline anterior skull-base region.\n4. Any other condition that, in the investigator's opinion, renders the participant unsuitable for enrollment.\n5. Patients with poor treatment compliance."}, 'identificationModule': {'nctId': 'NCT07465861', 'acronym': 'BRO', 'briefTitle': 'Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'The Impact of Postoperative Bed Rest Duration on the Reconstruction Outcomes of Endoscopic Endonasal Midline Anterior Skull Base Surgery: A Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'QYFYEC2025-205'}, 'secondaryIdInfos': [{'id': '2025-WJKY173', 'type': 'OTHER_GRANT', 'domain': 'Medical and Health Scientific Research Project of Qingdao'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-flow / non-bed-rest group', 'interventionNames': ['Behavioral: non-bed-rest']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-flow / 2-day bed-rest group', 'interventionNames': ['Behavioral: 2-day bed-rest']}, {'type': 'EXPERIMENTAL', 'label': 'High-flow / 1-day bed-rest group', 'interventionNames': ['Behavioral: 1-day bed-rest']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-flow / 3-day bed-rest group', 'interventionNames': ['Behavioral: 3-day bed-rest']}], 'interventions': [{'name': 'non-bed-rest', 'type': 'BEHAVIORAL', 'description': 'for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) non-bed-rest postoperatively', 'armGroupLabels': ['Low-flow / non-bed-rest group']}, {'name': '2-day bed-rest', 'type': 'BEHAVIORAL', 'description': 'for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) 2-day bed-rest postoperatively', 'armGroupLabels': ['Low-flow / 2-day bed-rest group']}, {'name': '1-day bed-rest', 'type': 'BEHAVIORAL', 'description': 'for patients with high-flow CSF leak (dural defect \\>1 cm²) 1-day bed-rest postoperatively', 'armGroupLabels': ['High-flow / 1-day bed-rest group']}, {'name': '3-day bed-rest', 'type': 'BEHAVIORAL', 'description': 'for patients with high-flow CSF leak (dural defect \\>1 cm²) 3-day bed-rest postoperatively', 'armGroupLabels': ['High-flow / 3-day bed-rest group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yan Jiang', 'role': 'CONTACT', 'email': 'jiangyanoto@qdu.edu.cn', 'phone': '+86 13256875886'}, {'name': 'Xudong Yan', 'role': 'CONTACT', 'email': 'yanxudong@qdu.edu.cn', 'phone': '+86 18661805302'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The data will become available 6 months after the publication of the primary results and will be accessible for 5 years thereafter.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) that underlie the results reported in the primary and secondary publications of this trial will be shared. This includes baseline demographics, surgical details, perioperative variables, outcomes data (e.g., reconstruction success, complication rates), and follow-up assessments.', 'accessCriteria': "Data will be shared with researchers who provide a methodologically sound proposal that has been approved by the study's data access committee. Approved users must sign a data use agreement, committing to using the data only for the approved purpose, not attempting to re-identify participants, and securing the data appropriately. Requests for data access can be directed to the corresponding author."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}