Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
Study NCT ID:
NCT06831695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-02-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Surgical Outcomes of Craniotomy and Craniectomy in Posterior Fossa Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003399', 'term': 'Craniotomy'}], 'ancestors': [{'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-15', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-15', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of CSF leakage', 'timeFrame': 'Up to 6 months post-surgery', 'description': 'Definition: CSF leakage is defined as the presence of clear fluid discharge from the surgical site, confirmed via clinical examination and biochemical analysis of β-2 transferrin.\n\nMeasurement: Evaluated by clinical assessment at routine follow-ups and imaging studies when indicated.'}, {'measure': 'Occurrence of pseudomeningocele', 'timeFrame': 'Up to 6 months post-surgery', 'description': 'Definition: Pseudomeningocele is defined as an abnormal collection of cerebrospinal fluid in the surgical site, detected through physical examination and confirmed by imaging techniques such as MRI or CT scan.\n\nMeasurement: Follow-up visits at 1, 3, and 6 months post-surgery.'}, {'measure': 'Severity of post-operative headache', 'timeFrame': 'Immediately post-surgery, at 3 months, and at 6 months post-surgery', 'description': 'Definition: Post-operative headache will be assessed using the Catalano grading system, categorizing severity from 0 (no headache) to 4 (severe, refractory to medication).\n\nMeasurement: Self-reported patient evaluations at each follow-up visit.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'From immediate post-surgery until hospital discharge, assessed up to 4 weeks', 'description': 'Definition: The total number of days a patient remains hospitalized post-surgery, including any extended stay due to complications.\n\nMeasurement: Recorded from hospital admission to discharge.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Craniotomy', 'Craniectomy', 'Neurosurgery', 'Posterior Fossa', 'Brain Tumors'], 'conditions': ['Posterior Fossa Lesion']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized controlled trial is to compare the surgical outcomes of craniotomy and craniectomy among patients with posterior fossa lesions. The study aims to determine differences in post-operative complications, hospital stay duration, and patient recovery between the two surgical techniques.', 'detailedDescription': 'Patients diagnosed with posterior fossa lesions will be randomly assigned into two groups. Group A will undergo craniotomy, where the bone flap is replaced after dural closure, while Group B will undergo craniectomy, where the bone is permanently removed. Outcomes will be assessed based on post-operative complications such as CSF leakage, pseudomeningocele formation, post-operative headache, and length of hospital stay. The study aims to provide evidence to determine the superior surgical approach in terms of patient outcomes and healthcare cost reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with posterior fossa lesions\n* Age range: 7-70 years\n* Patients with cerebellar hematoma (traumatic or spontaneous)\n\nExclusion Criteria:\n\n* Previous posterior fossa surgery\n* Brainstem hematoma\n* Tumors involving the overlying dura or bone'}, 'identificationModule': {'nctId': 'NCT06831695', 'briefTitle': 'Comparison of Surgical Outcomes of Craniotomy and Craniectomy in Posterior Fossa Lesions', 'organization': {'class': 'OTHER', 'fullName': 'University of Health Sciences Lahore'}, 'officialTitle': 'Comparison Between Surgical Outcomes of Craniotomy and Craniectomy Among Patients with Posterior Fossa Lesion', 'orgStudyIdInfo': {'id': 'Exp128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Craniotomy', 'description': 'This procedure involves creating a single free bone flap using high-speed drills. The bone is repositioned and secured using mini plates or sutures after the surgical intervention is completed. Post-operative monitoring will include assessment for CSF leakage, wound healing, and neurological recovery.', 'interventionNames': ['Procedure: Craniotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Craniectomy', 'description': 'In this approach, the bone is removed in pieces using rongeurs, leaving an open dural surface without replacement of the bone. The dura is closed with sutures, and dural augmentation may be performed as needed. Post-operative assessment will focus on complications such as pseudomeningocele, CSF leakage, and extended hospital stays.', 'interventionNames': ['Procedure: Craniectomy']}], 'interventions': [{'name': 'Craniotomy', 'type': 'PROCEDURE', 'description': 'Intervention: Bone flap replaced after dural closure Additional Information: This procedure involves creating a single free bone flap using high-speed drills. The bone is repositioned and secured using mini plates or sutures after the surgical intervention is completed. Post-operative monitoring will include assessment for CSF leakage, wound healing, and neurological recovery.', 'armGroupLabels': ['Group A: Craniotomy']}, {'name': 'Craniectomy', 'type': 'PROCEDURE', 'description': 'Intervention: Bone permanently removed Additional Information: In this approach, the bone is removed in pieces using rongeurs, leaving an open dural surface without replacement of the bone. The dura is closed with sutures, and dural augmentation may be performed as needed. Post-operative assessment will focus on complications such as pseudomeningocele, CSF leakage, and extended hospital stays.', 'armGroupLabels': ['Group B: Craniectomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dr. Birat Thapa Magar, Post Graduate Resident', 'role': 'CONTACT', 'email': 'biratjmagar.5@gmail.com', 'phone': '+923057895437'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Birat Thapa Magar', 'investigatorAffiliation': 'University of Health Sciences Lahore'}}}}