Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury

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

Interventions

PROCEDURE

Decompressive Craniectomy

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.

PROCEDURE

Cisternostomy

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.

Sponsors & Collaborators

• University of Health Sciences Lahore

  lead OTHER

Principal Investigators

• DR. MUSTAPHA SHESH, MS Neurosugery · University of Health Sciences Lahore

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2025-05-01

Completion

2025-05-01