Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury

NCT06363474 | Not Yet Recruiting

• 1 other identifier: UHS 5532
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Severe Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS).

  The primary outcome of this study is the comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS).

  12 months

Study Arms (2)

Group A - Decompressive Craniectomy

EXPERIMENTAL

Patients allocated to Group A will undergo decompressive craniectomy, a neurosurgical procedure involving the removal of a section of the skull (bone flap). This procedure aims to alleviate intracranial pressure (ICP) and provide additional space for the swollen brain to expand. The surgery will be performed by a single surgical team under general anesthesia. Following the procedure, patients will be closely monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge.

Procedure: Decompressive Craniectomy

Group B - Cisternostomy

ACTIVE COMPARATOR

Arm Description: Patients allocated to Group B will undergo cisternostomy, a microsurgical technique used in neurosurgery. This procedure involves the creation of an additional space for cerebrospinal fluid (CSF) circulation to alleviate brain edema and lower intracranial pressure (ICP). The surgery will be performed by the same surgical team under general anesthesia. Postoperatively, patients will be monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge.

Procedure: Cisternostomy

Interventions

Decompressive Craniectomy PROCEDURE

Patients allocated to this arm will undergo decompressive craniectomy, which involves the surgical removal of a section of the skull (bone flap). This procedure is performed to alleviate intracranial pressure (ICP) by providing additional space for the swollen brain to expand. The surgery will be performed by a single surgical team under general anesthesia. After the procedure, patients will be closely monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge.

Group A - Decompressive Craniectomy

Cisternostomy PROCEDURE

Patients allocated to this arm will undergo cisternostomy, a microsurgical technique used in neurosurgery. Cisternostomy involves the creation of an additional space for cerebrospinal fluid (CSF) circulation to alleviate brain edema and lower intracranial pressure (ICP). The surgery will be performed by the same surgical team under general anesthesia. Following the procedure, patients will be monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge.

Group B - Cisternostomy

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Unilateral mass effects such as an acute subdural haematoma greater than 10mm or a midline shift greater than 5mm on computed tomographic (CT) post-trauma.
• Refractory ICP despite medical management (based on intracranial pressure monitoring.
• GCS \>5 and \<10 following traumatic head injury
• Age \< 60 years

You may not qualify if:

• Brainstem dysfunction and signs of irreversible brain damage ( i.e bilaterally non-reactive pupils)
• Severe haemodynamic instability ( i.e polytrauma)
• Bleeding diathesis
• Previous head injury
• Malignant pathology
• Previous cranial surgery

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Decompressive Craniectomy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Decompression, Surgical; Surgical Procedures, Operative; Craniotomy; Neurosurgical Procedures

Study Officials

• DR. MUSTAPHA SHESH, MS Neurosugery

  University of Health Sciences Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Mustapha Shesh, MSNeurosugery

CONTACT

03166951158; sheshmustapha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, M.S Neurosurgery

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share