COGNITIVE AND QUALITY OF LIFE

OUTCOMES IN PATIENTS WITH SEVERE

TRAUMATIC BRAIN INJURY WHO

UNDERWENT DECOMPRESSIVE

CRANIECTOMY.
 CONTENTS

1. INTRODUCTION

2. AIM AND OBJECTIVE

3. REVIEW OF LITERATURE

4. MATERIALS AND METHODS

5. DISCUSSION

6. BIBLIOGRAPHY

7. INFORMATION SHEET

8. CONSENT FORM

9. PATIENT INFORMATION PROFORMA

INTRODUCTION

The severity of Traumatic Brain Injury (TBI) is conventionally described

through the use of Glasgow Coma Scale (GCS). A GCS of 13-15

conventionally represents a mild injury, 9-12 a moderate injury and 3-8 a

severe injury. A study on the epidemiological aspect of traumatic brain

injury by Gururaj G et al (2003), using the Glasgow Coma Scale, revealed

that severe, moderate and mild head injuries constituted 16%, 14% and

70%, respectively.(1)

Among the many problems that arise as a result TBI, intracranial hypert-

-ension (IHT) is a major cause of complications and death. Thus, it is

comprehensible that neurosurgeons perform considerable effort to

controlling intracranial pressure (ICP) in patients with TBI.

Decompressive craniectomy (DC) has been advocated as one strategy for

managing ICP.(2)

DC is a neurosurgical procedure in which part of the skull is removed. It is

performed on victims of traumatic brain injury, stroke and other

conditions associated with raised intracranial pressure.

When the brain swells following an injury, the pressure in the brain can

build inside the skull, causing further damage. The aim of the procedure is
to
decrease the mass effect, thereby preventing brain ischemia, herniation and

death.

There are reports suggesting that DC may improve underlying physiological

abnormalities and there are improvements in cognition and quality of life.

We wish to undertake this prospective study to assess cognitive and

qualitative outcome of patients after DC using appropriate psychometric tests.

1. AIM:

To study the impact of decompressive craniectomy on severe traumatic brain

injury (sTBI) patients with regards to the course of neuropsychological and

quality of life outcomes.

2. OBJECTIVES:

To study the neuropsychological alterations in patients with sTBI for

a period of 6 months.

 To study the quality of life outcomes in patients with sTBI for a

period of 6 months.
REVIEW OF LITERATURE

The earliest evidence of skull trephination dates back to 10,000 BC at

the beginning of the Neolithic period and has been deduced by studying

the major skull collections: the French Prunières collection and the

Peruvian skulls.

The first scientific reference and description of an hemicraniectomy was

reported in 1896 by Charles Adrien Marcotte in his graduation thesis in

Medicine and Surgery, named De L'hemicraniectomie Temporaire.

The use of “large” DC for patients with raised intracranial pressure

following TBI was firstly reported by Kocher in 1901. He suggests to

perform the temporary hemicraniectomy in selected cases where a

pressure relief cannot be achieved by trephination alone.

Monro-Kellie doctrine, or hypothesis, is that the sum of volumes of

brain, CSF, and intracranial blood is constant. An increase in one should

cause a decrease in one or both of the remaining two.

Intracranial hypertension is a critical event frequently occurring after

traumatic brain injury (TBI) as a delayed secondary pathologic process

initiated at the moment of injury. Due to the rigid nature of the skull and

the dura, brain edema, expanding hematomas, or blossoming of contus-

ion can rapidly exhaust the compensation mechanisms leading to

maintenance of a controlled intracranial pressure (ICP). These events

lead to a vicious cycle whereby reduced cerebral perfusion pressure

(CPP) causes reduction of cerebral blood flow (CBF) and oxygenation,

with worsening of brain edema and, eventually, brain herniation, and

death. Following failure of medical management, decompressive

craniectomy (DC), a procedure consisting on removal of part of the skull

and opening of the underlying dura, can be used as a last-tier therapy to

mitigate ICP elevation.

DC has many known complications with rates as high as 53.9%. Long-

term deleterious neurocognitive and psychosocial effects leading to poor

quality of life and social burden are well known following DC.

Oretha et al. studied majority of patients who underwent decompression of

craniectomy had good functional results, which were analyzed using the

Extended Glasgow Outcome Scale (GOS) assessment. Overall, 30% of

severe brain injury patients undergoing decompression of craniectomy have

favorable long-term outcomes. In contrast to research at the Berlin

Waterfall in Berlin (UKB) in the period September 1997 to September

2005, 131 patients with severe traumatic brain injury who received

decompression due
to craniectomy, most had a poor prognosis. Research measured using the

Glasgow Outcome Scale (GOS) obtained results, sixty-three patients (48%)

died in hospital (GOS 0) and 27 (21%) were discharged in a vegetative state

(GOS 2). Thirty-two patients (24%) were severely disabled, while nine

others (7%) had moderate disabilities. At an average of 49 months after

surgery, 75 patients (68%) died or were in a vegetative state (GOS 1 and 2).
MATERIALS AND METHODS
It is a prospective analytical study; the study population shall include all

patients with severe traumatic brain injury underwent decompressive

craniectomy within one year by the Department of Neurosurgery, Patna

Medical College, Patna. Patients will be followed up at 1 month, 3 month and

6 months.

Inclusion criteria:

Patients with severe traumatic brain injury who underwent DC

Age 18-65 years.

GCS ≤ 8 .

CT scan with evidence of acute SDH, unilobar or bilobar contusions with

cerebral edema, midline shift >5mm.

Exclusion criteria:

Age less than 18 years and more than 65 years.

Patients with associated severe chest, abdominal or orthopedic trauma.

Prior psychiatric illness.

 Alcohol or drug dependence.
Previous history of brain injury.
Existing or any previous neurological illness.
Patients who cannot read, write and have not received at least 3 years of

formal education.

Patients or his/her attendants not willing for surgery or study.

All these patients will be briefed about the study and consent will be

obtained after explaining in detail in the language in which they will be able

to understand about the study.

Sequential sampling shall be done i.e. first 100 patients who fulfil criteria
and consent for the study during the recruitment period of 1 year, July 2023-
June 2024. The study proforma shall be filled at the first visit and
assessments shall be done at 1, 3 and 6 months from the date of trauma.

Thus, the study will be completed when the last recruited patient finishes
the 6 months assessment.

Assessment on the day of first visit of a study patient:

On the first visit (Emergency department), demographic and clinical data

will be collected as per patient information proforma.

Assessment on subsequent visits:

Study patients will be evaluated at 1 month, 3 months and 6 months post

DC.
On each of these visits in addition to routine history and clinical examination,
patients will be assessed with simple questionnaires for cognitive outcomes
using ACE-Ⅲ score and quality of life outcomes using WHOQOL-BREF scor
DISCUSSION

The outcome of study will be compared with previous studies and

discussed in detail.

BIBLIOGRAPHY

(1). Romer C, Holst HV, Gururaj G, et al. Prevention,Critical Care and

Rehabilitation of Neurotrauma. Perspectives and Future
Strategies,WHO Collaborating Centers for Neurotrauma, 1999

(2). Holland M, Nakaji P. Craniectomy: surgical indications

and technique. Neurotrauma. 2004;7(1):10–15.

(3). Moon JW, Hyun DK. Decompressive craniectomy in traumatic brain

injury: a review article. Korean J Neurotr. (2017) 13:1–8.

10.13004/kjnt.2017.13.1.1

(4).Marcotte CA. De L'hémicraniectomie Temporaire. Paris: Institut

International de

Bibliographie Scientifique; (1896).

(5). Kocher T. Hirnerschütterung, Hirndruck und chirurgische Eingriffe

bei Hirnkrankheiten. Wien: Alfred Hölder; (1901).

(6). Cooper DJ, Rosenfeld JV, Murray L, Arabi YM, Davies AR, D'Urso P, et
al.. Decompressive craniectomy in diffuse traumatic brain injury. N Engl J
Med. (2011) 364:1493–502. 10.1056/NEJMoa1102077

(7). Ban SP, Son YJ, Yang HJ, Chung YS, Lee SH, Han DH. Analysis
of complications following decompressive craniectomy for traumatic
 brain injury. J Korean Neurosurg Soc 2010;48(03): 244–250
(8). van Middelaar T, Nederkoorn PJ, van der Worp HB, Stam J, Richard E.
Quality of life after surgical decompression for space-occupying middle
cerebral artery infarction: systematic review. Int J Stroke 2015;10(02):170–
176 12 Hanko M, Soršák J, Snopko P, Opšenák R, Zeleňák K, Kolarovszki B
(9). Oretha Istiqomah Sunarto, Abdul Hafid Bajamal, Abdurachman.
Outcome of Brain Injury Patients After Decompressive crainectomy in
Tertiary Referral Hospital in East Java Indonesia. Research J. Pharm.
and Tech. 2019; 12(12): 6057-6061
INFORMATION SHEET

Patna Medical College and Hospital, Patna Volunteer

Information Sheet for Relative/Guardian of those considered for the

study TITLE: COGNITIVE AND QUALITY OF LIFE OUTCOMES IN

PATIENTS WITH SEVERE TRAUMATIC BRAIN INJURY WHO

UNDERWENT DECOMPRESSIVE CRANIECTOMY.

We are conducting a study to understand the impact of severe traumatic

brain injury (sTBI) on patients with regards to their mental and physical

wellbeing before and after the head injury. This study is being conducted by

Dr. KUNAL KUMAR belonging to the Department of Neurosurgery under

the guidance of Dr. ARUN KUMAR AGRAWAL, HOD, Dept. of

Neurosurgery, PMCH, Patna.

This sheet contains the details of the study. If you wish, we are ready to read

and explain the same to you. If you find something difficult to understand

about the study or if you want any more details we are ready to provide the

same.

We have chosen your relative to be a part of the study as he/she has mild

traumatic brain injury and fulfils the inclusion criteria, and their clinical and

investigation data will be useful for our study. By participating in this study,
you need to allow us to utilize their clinical data and during their regular

follow-up sessions in our out-patient department at 1,3- and 6-months post

trauma, they will be given two different simple questionnaires to fill. Their

confidentiality will be maintained and their identity will not be revealed

anywhere. If you and they wish to know the results of the study then the same

will be disclosed by the investigator. Their participation in the present study is

solely on voluntary basis, they will not be paid for participation, we will not

include your relative in the study. Even if you do not participate in the study,

your relative will continue to receive the same kind of treatment. You or your

relative has the power to withdraw from the study at any time. We welcome

your relative and thank you for having accepted our request to consider

whether you can allow your relative to participate in our study.

CONSENT FORM

Patna Medical College And Hospital, Patna Informed Consent From the

relative/guardian of the participant

TITLE: COGNITIVE AND QUALITY OF LIFE OUTCOMES IN PATIENTS

WITH SEVERE TRAUMATIC BRAIN INJURY WHO UNDERWENT

DECOMPRESSIVE CRANIECTOMY.

I have been informed about the details of the

study in my own language. I have understood the details about the study.

I understand that my relative’s.........................................(Name)

participation is voluntary and that I am free to withdraw my relative from

the study at any time, without giving any reason and my relative will

continue to get the medical treatment as usual. I understand that I will not

get any payment for taking part in this study. I will not object if the result of

this study is getting published in any medical journals, provided my

relative’s personal identity is not revealed. I know what my relative is

supposed to do by taking part in this study and I assure that he /she will

give full co-operation for this study.

Name of the participant’s

relative: Date:
For...........................................................................(Name of the participant)

Address:

Signature:

Name of the witness:

Address:

Signature:

Name of the investigator:

Signature of the investigator: