protocolSection identificationModule nctId: NCT06363474, orgStudyIdInfo id: UHS 5532, briefTitle: Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Health Sciences Lahore, class: OTHER, descriptionModule briefSummary: The objective of this clinical study is to compare the outcomes of two neurosurgical interventions, Cisternostomy and Decompressive Craniectomy (DC), for the management of severe Traumatic Brain Injury (TBI), assessed using the Glasgow Outcome Scale (GOS). Severe TBI presents challenges in managing intracranial pressure (ICP) and cerebral perfusion, often requiring surgical intervention. DC involves the removal of a section of the skull to reduce ICP, while Cisternostomy, a technique rooted in microsurgery, aims to alleviate brain edema and lower ICP by creating additional space for cerebrospinal fluid (CSF) circulation.This prospective study will be conducted at the Department of Neurosurgery, Punjab Institute of Neurosciences, Lahore. Patients meeting inclusion criteria will be randomized into Group A (DC) and Group B (Cisternostomy) following brain CT scans. Clinical evaluation will include regular follow-ups for 6 months post-surgery, recording data on GOS, duration of mechanical ventilation, ICU, and hospital stays. Analysis will be performed using SPSS 24, comparing outcomes between groups using Chi-square test and t-test. A significance level of p≤0.05 will be applied.It is hypothesized that Cisternostomy, as an adjunct to traditional TBI management, will effectively reduce ICP, resulting in improved GOS and reduced complications postoperatively, including decreased duration of mechanical ventilation and ICU stay, with sustained improvement observed at 6 months, conditionsModule conditions: Severe Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention model of this study is a parallel model. Patients meeting inclusion criteria are enrolled from the neurosurgery department of Punjab Institute of Neurosciences, Lahore. After obtaining consent, patients undergo detailed assessments and investigations. They're randomly assigned to Group A (decompressive craniectomy) or Group B (cisternostomy). Both procedures are performed by a single surgical team under anesthesia. Postoperatively, patients are monitored for mechanical ventilation duration, ICU and hospital stay lengths, and Glasgow Outcome Scale at discharge. This model enables outcome comparison between intervention groups while controlling confounding variables., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule interventions name: Decompressive Craniectomy, interventions name: Cisternostomy, outcomesModule primaryOutcomes measure: comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS)., eligibilityModule sex: ALL, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False