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Synopsis 16-5-2023
Synopsis 16-5-2023
By
Dr. Junaid Nawaz
For
M.S. (Neurosurgery)
Under supervision of
M.S. Neurosurgery
Matriculation 2009
ii
Name of Post Graduate Institution:
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Table of Contents
LIST OF ABBREVIATIONS......................................................................................................v
PROJECT SUMMARY...............................................................................................................1
INTRODUCTION.......................................................................................................................3
LITERATURE REVIEW............................................................................................................6
HYPOTHESIS.............................................................................................................................9
OBJECTIVES............................................................................................................................10
OPERATIONAL DEFINITION:...............................................................................................11
MATERIAL AND METHODS.................................................................................................13
METHODOLOGY:...................................................................................................................18
DATA ANALYSIS:..................................................................................................................20
OUTCOME UTILIZATION.....................................................................................................21
LIMITATIONS:........................................................................................................................22
REFERENCES..........................................................................................................................23
Annexure I.................................................................................................................................24
Annexure II................................................................................................................................25
Annexure III...............................................................................................................................27
Annexure IV..............................................................................................................................28
Annexure V................................................................................................................................29
iv
LIST OF ABBREVIATIONS
v
PROJECT SUMMARY
Primary tumors arising in the sella turcica and the suprasellar region
comprise approximately 10% of all primary brain tumors. Depending on the site
of origin and the size of the lesions, a wide range of clinical presentations is
encountered. Pituitary dysfunction and visual difficulties are the most common,
The present study is being conducted to test the hypothesis that pituitary
tumors which are smaller in size have better visual outcome as compared to
objectives of the present study To compare the visual outcomes of sellar supra
sellar tumor surgery viz size of the tumor when removed by endoscopic
endonasal surgery.
year after approval of synopsis. Patients who fulfill our predefined inclusion
(tumor size less than 1 cm whereas group B will contain macroadenomas (tumor
size equal to or greater than 1 cm) sellar supra sellar tumors. The patients will
be kept on follow-up for six months and all study parameters will be
documented on pro-forma.
1
All the data will be entered and analyzed using SPSS 25. Quantitative data
like age, pathology will be presented by the mean and standard deviation.
Stratification will be done based on age, gender and size of the tumor to see its
effect on the final outcome i.e. visual outcomes. Qualitative & Quantitative data
will be tabulated, and a Comparison of the two groups will be made. Chi-Square
tumors which are smaller in size have better visual outcome as compared to
literature, it has been reported that endoscopic approach is more successful and
we want to conduct this study. This will help to improve our practice.
This study will not be blinded as all concerned will know about the
surgery; Adenomas
2
INTRODUCTION
Primary tumors arising in the sella turcica and the suprasellar region
comprise approximately 10% of all primary brain tumors. Depending on the site
of origin and the size of the lesions, a wide range of clinical presentations is
encountered. Pituitary dysfunction and visual difficulties are the most common,
Pituitary adenomas are tumors that occur in the pituitary gland. Pituitary
adenomas are generally divided into three categories dependent upon their
represent from 10% to 25% of all intracranial neoplasms and the estimated
and Kelly, 2019) . Pituitary adenomas are associated with increased morbidity
and mortality.
open craniotomy was first described by Horsley. Since then, the field of
pituitary surgery has undergone constant evolution. Schloffer et al. were the
Cushing et al. who abandoned external incisions and popularized the sublabial
3
transseptal / translabial approach has long been considered as the standard
minimal invasiveness, which allows surgeons to gain access to central skull base
effective treatment for all patients with Cushing’s disease. Recurrence rates
popular for the removal of pituitary adenomas. It is also widely recognised that
4
LITERATURE REVIEW
visualize the full extent of the tumor. These open approaches generally utilize a
corridor which passes directly around cranial nerves and vascular structures,
which lie between the surgeon and the tumor, in order to reach the pathology.
to achieve these goals for giant PAs (Karki et al., 2017). However, visualization
into the supra-sellar cistern is limited. For this reason, some authors have
lying beyond the tumor from the surgeon’s trajectory. These approaches have
been associated with lower morbidity than open transcranial surgery for
lesions with suprasellar extension, TSE microscopic techniques have been used,
though the longer working distance and distant illumination can make complete
5
and safe resection difficult through the narrow corridor provided by the Hardy
retractor.
endoscopic pituitary surgeries for visual improvement. They concluded that the
pituitary surgery.
Suri et al., (2008) conducted a study to assess the visual outcome after
perception of light in 1 or both eyes and who underwent surgery between May
2002 and May 2006 were included in this retrospective study. Outcome was
analyzed at discharge from the hospital and at follow-up. There were a total of
79 patients (51 males and 28 females, age range 5–70 years). There were 37
had binocular blindness. Of all 158 eyes, 97 (61.4%) were blind at admission
and these eyes were analyzed. Sixty-three patients (79.7%) presented with
headache and 14 (17.7%) with hypothalamic symptoms. Nearly one fourth (24%)
visual decline ranged from 3 days to 7 years, and the duration of blindness
6
improvement was exhibited in 23 (29%) of 79 patients and 27 (27.8%) of 97
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HYPOTHESIS
pituitary tumors which are smaller in size as well as the larger ones when
visual field defects as compared to the larger ones when removed endoscopically
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OBJECTIVES
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OPERATIONAL DEFINITION:
Visual Outcomes:
and/or surgical instruments are inserted into part of the brain by going through
the nose and the sphenoid bone (a butterfly-shaped bone forming the anterior
inferior portion of the brain case) into the sphenoidal sinus cavity.
10
11
MATERIAL AND METHODS
Sample Size: The sample size was calculated using n = (Zα/2+Zβ)2 * (p1(1-p1)+p2(1-
p2)) / (p1-p2)2,
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Group A: will contain microadenomas (tumor size less than 1 cm
n=48
1 cm
n=48
13
Sampling Technique and Randomization:
Consecutive Sampling.
for sellar supra sellar tumors, whereas group B will undergo Endoscopic
definition.
14
Sample Selection
Inclusion Criteria:
program
b. Nausea
c. Vomiting
Exclusion Criteria:
5. Tumors that infiltrate the nasal septum, pterygoid fossa, or the anterior
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6. Non pneumitization of conchal floor of sphenoid sinus
7. Sphenoid Sinusitis
a. Circulatory Pathology
b. Cardiac Pathology
c. Pulmonary pathology
e. Pregnancy
f. Morbid obesity
g. Malignancy
13.
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METHODOLOGY:
After approval of my synopsis from institutional review board, 96 patients
in fulfilling the inclusion criteria will be enrolled in the study. Patients will be
recruited from the indoor and the emergency department of Punjab Institute of
Neurosciences. Written and informed consent will be taken from each patient.
and radiological findings. Each patient will undergo MRI brain plain and
surgery.
supra. Group A will undergo TCA for sellar supra sellar tumors, whereas group
B will undergo Endoscopic Endonasal approach for sellar supra sellar tumors.
Neurosurgeon will execute all surgical procedures in the elective list. A single
on the first post-operative day, at the time of discharge, and then at their OPD
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acuity using Snellen chart. All the results will be collected and recorded on a
Pro-forma (attached).
18
DATA ANALYSIS:
All the data will be entered and analyzed using SPSS 25. Quantitative data
like age, pathology will be presented by the mean and standard deviation.
Stratification will be done based on age, gender, type of procedure, to see its
effect on the final outcome ie visual outcomes. Qualitative & Quantitative data
will be tabulated, and a Comparison of the two groups will be made. Chi-Square
19
OUTCOME UTILIZATION
Pakistan is low-income country with over 200 million populations, with
sellar suprasellar tumors. This study has been planned to compare 2 surgical
modalities for the treatment of giant pituitary adenomas. The results will
provide future guidelines for the surgical treatment of giant pituitary adenomas
in Pakistan.
20
LIMITATIONS:
1. The present study is limited by small study durations due to which the
per study protocols, yet the patients will be kept on followup from the
2. This study will not be blinded as all concerned will know about the
21
REFERENCES
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Annexure I
PROFORMA
Visual improvement in sellar supra sellar tumor surgery by open C&E vs endoscopic trans
sphenoidal approach
Biodata
Name
Father’s Name
MR Number
Date of Admission
Date of Surgery
Procedure Details
Date of Discharge
Group: A B
Visual Acuity
Pre Operative
Immediate Post operative
24 hour post op
OPD follow up
Follow Up
1. 12 Hour Post Op
2. 1st Week
3. 2nd Week
4. 4th Week
5. 8th Week
6. 12th Week
7. 16th Week
8. 20th Week
9. 24th Week
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Annexure II
CONSENT FORM
I.D. Number _________________________________
his research titled “Visual improvement in sellar supra sellar tumor surgery by open C&E vs endoscopic trans
I am also informed regarding the purpose, nature, aims, and objectives of the Study / Procedure as well as the
expected risks and benefits of the surgery and other materials being used during this study. I have also been
explained the procedure of random allocation to any of the study groups and the fact that surgical procedures
All the information in this process will be kept confidential, and my name and other data will be utilized only for
research purposes. I have been informed that I can ask any type of question-related to the study. I have also been
informed that this research is not just for the benefit of a single person but for humanity at large.
If, after the briefing, I refuse to participate, there will be no obligation on my side, and I shall be treated in routine. I
may withdraw from the study at any time during the course of the study, and I shall not be forced to continue. I give
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URDU CONSENT FORM
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Annexure III
ESTIMATED COST OF RESEARCH PROJECT
Since Punjab Institute of Neurosciences, Lahore General Hospital is a public sector Institution,
all the surgical and admission charges are free of cost, and the patient will incur no cost.
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Annexure IV
GANTT CHART (Plan of Work)
Task Time Line (Months)
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15
Data Collection
Randomization
Follow-up
Literature Search
Statistical Analysis
Final Write-up
Supervisor Review
Thesis Submission
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Annexure V
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