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Incidence of Recurrent Laryngeal Nerve Palsy Following Thyroid Surgery
Incidence of Recurrent Laryngeal Nerve Palsy Following Thyroid Surgery
Background:
Thyroid surgery has been associated with complications ranging from nerve injury to death.
thyroid surgery. As the RLN innervates all intrinsic muscles of the larynx except the
cricothyroid muscles, injury of this nerve induces a paresis or palsy of the vocal cord. The
patient often presents with postoperative dysphonia that may or may not be associated with
deglutition problems or dyspnea. These symptoms can resolve rapidly or can persist over
time depending on the injury type (e.g., heat, compression, stripping and section).
Aim: This study aims is to determine the frequency of recurrent laryngeal nerve palsy among
Otolaryngology - Head & Neck Surgery, BSMMU, Dhaka, for one and a half years from
January 2022 to June 2023, with 60 patients diagnosed with thyroid disease admitted in In
Patient Department (IPD). The subjects will be selected on the basis of inclusion and
exclusion criteria. All of these patients will be evaluated by a complete ENT examinations.
All the data will be compiled and sorted properly, and the numerical data will be analyzed
statistically by using the Statistical Package for Social Scientists (SPSS-26.0) (Evolution or
trial version). Demographic characteristics and study variables will be analyzed using
descriptive statistics. The results of the study will be expressed as mean, standard deviation
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(± SD), frequency, and percentages. Means and standard deviations will be reported for
continuous variables. Frequencies and percentages will be reported for categorical variables.
Student's t-test will be done to compare the continuous variables, and the Chi-Square test will
be done to compare the categorical variables. p-value <0.05 will be considered as the level of
significance.
Ethical issue: The nature and purpose of the study will be informed in detail to all
psychological, and social risks to the subjects. Informed and understood written consent will
be taken from every patient before enrollment. Privacy, anonymity, and confidentiality of
data information identifying any patient will be maintained strictly. Each patient will enjoy
every right to participate or refuse or even withdraw from the study at any point in time.
Before starting this study ethical clearance will be taken from the Institutional Review Board
(IRB) of BSMMU. Data taken from the participants will be regarded as confidential and kept
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Introduction
The thyroid gland is the largest of the discrete endocrine organs typically weighing between
15 and 25 gram, being slightly larger in women, dependent upon age, nutritional and
hormonal status (Gleeson MB, et al.). Macroscopically the normal thyroid gland presents a
bilobate structure with a reddish-brown colour. The two lobes are connected by a central
Thyroid disorders are common; serious or sinister problems are rare. They are broadly be
divided into disorders of function and disorders of structure, with a few miscellaneous
others.
Thyroid nodules are common in adults and may be palpated in 3-7% of cases. (Hegedus L,
Bonnema SJ, Bennedback FN. 2003) If ultrasound is used, the prevalence is nearer 70%.
(Perros P, Buelart K, Colley S et al. 2014) The majority of thyroid nodules are solitary, but
they may be part of a multinodular goiter. A focal or diffuse goiter can occur
Bangladesh is an endemic area for iodine deficiency goiter. Many patients present with
diffuse or multinodular goiter. In many cases non neoplastic goiter present as a solitary
thyroid nodule (STN). Most of the STN are benign, few are malignant.
Ionizing radiation exposure, change in iodine nutrition and more sensitive diagnostic test
availability are proposed as the reasons for the worldwide rise in the incidence of thyroid
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The commonest presentation of a thyroid nodule is with an asymptomatic lump. Increasingly
referrals are arising as incidental findings from radiological investigation. Pain, rapid
increase in size, hoarse voice and the presence of a lateral neck mass are all the features that
raise concern about a malignant underlying pathology, but the commonest cause for sudden
painful thyroid nodule is bleeding into a pre-existing cyst and the commonest presentation of
Coatesworth AP 2005) With increasing size, goitres can cause compressive symptoms; these
are usually at or above the level of the thoracic inlet, causing cervical dysphagia, exertional
dyspnoea, inspiratory or biphasic stridor and venous congestion of the superior vena caval
Thyroid surgery is one of the commonest neck surgeries performed worldwide. Common
anticipate and avoid the occurrence of possible surgical complications. (Doumi EA,
hypoparathyroidism and Recurrent Laryngeal Nerve Injury (RLNI) represent nearly half of
all the complications of thyroid surgery (Ready AR, Barnes AD. 1994). RLN injury is an
annoying but avoidable complication which results from severing, clamping or stretching of
the nerve during surgery and may result in severe untoward sequelae for patient (Souza LS,
Crespo AN, Alves de Medeiros JL, 2009). Vocal palsy is one the most common
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complications after thyroid surgery. The resulting phonetic paralysis is not only serious
impairment for patients who rely on their voice professionally, but it may also lead to serious
disturbances in ventilation in cases with bilateral vocal palsy (Feng-Yu Chiang et. al. 2004).
Recurrent laryngeal nerve (RLN) injury is a well-known and potentially serious complication
of thyroid surgery. From vocal cord dysfunction to acute airway emergencies, injuries to the
RLN can lead to a variety of complications ranging in severity. Most injuries are temporary,
not life-threatening, and recover within 6 months of surgery. Despite this, RLN injuries
remain significant outcome measures because they negatively affect patients quality of life
and increase their subsequent health-care utilization. Known risk factors include reoperative
the RLN during surgery has increased despite lack of conclusive evidence of its superiority
Anatomically, the left and right RLNs are different. The left is longer, usually 12 cm from
where it winds around the ligamentum arteriosum to the larynx, whereas the right RLN is
usually 6 cm from where it winds around the subclavian artery to the larynx. The left RLN
tends to run within the tracheoesophageal groove. Damage to a RLN with resultant paralysis
of the sole abducting muscle (posterior cricoarytenoid) of the vocal cord can cause
symptoms ranging from almost undetectable hoarseness in unilateral lesions to stridor and
acute airway obstruction in bilateral damage (Erbil Y, Barbaros U, Issever H et al, 2007).
RLN palsy following thyroid surgery is one of the leading reasons for medico-legal litigation
against surgeons.
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Rationale of the study
Recurrent laryngeal nerve palsy is one of the most common complication after thyroid
surgeries. Sequalae of the RLN palsy are hoarse voice, airway difficulty, weakened cough
laryngeal nerve with a precise surgical technique. In this study we are going to study the
incidence of RLNI after thyroid surgeries. To date, there is limited published literature on the
topic and so far after massive search, no thesis has been published in this topic at BSMMU.
So this study will be helpful to provide evidence-based information to the surgeons as well
as patients group about the RLN palsy after thyroid surgery and it also help for further
Research question
What is the incidence of recurrent laryngeal nerve injury following thyroid surgery in
BSMMU?
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Objectives
General objective:
To know the frequency of recurrent laryngeal nerve injury after thyroid surgery in
To know the frequency of recurrent laryngeal nerve injury after thyroid surgery in
Specific objectives:
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Materials & Methods
3. Place of the Study: This study will be carried out in the Department of
6. Ethical clearance: Before starting this study, the research protocol will be approved by
7. Sample size: 60
The representative sample size was determined by the following statistical formula
{u [ √ π ( 1−π ) ] +v [ √ π ( 1−π 0 ) ] }
2
0
n= 2
( π−π 0 )
Π1 = 10%, is the value of the population proportion under the alternative hypothesis
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Π0 = 2%, is the value of the population proportion under the null hypothesis, (Sikdar
u = 1.96
v = 0.84
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Inclusion and Exclusion criteria
Inclusion criteria:
Patients who will be admitted to the Department of Otolaryngology - Head & Neck
Surgery at BSMMU, Shahbag, Dhaka with diagnosis of thyroid disease that needed
surgery.
Exclusion criteria:
History of Hemi/Total thyroidectomy
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Study Design
Flow Chart
Data collection
Statistical analysis
Report writing
Correction of script by
supervisor
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Study Procedure
This study will be carried out at the Department of Otolaryngology - Head & Neck Surgery,
BSMMU, Shahbag, Dhaka from Jan 2022 to Jun 2023, after obtaining clearance and
approval from the Institutional Review Board. Patients admitted to the department with
thyroid swelling and fulfill the inclusion and exclusion criteria will be recruited as subjects in
the study. After the selection of the subjects, the nature, purpose, and benefit of the study will
be explained to the patient and guardian in detail. They will be encouraged to participate
voluntarily. They will be allowed to withdraw from the study at any time. Informed written
consent will be taken from the participants. A detailed history will be taken. A thorough ENT
examination, including thyroid gland examination and related systemic examinations, will be
done. Preoperative arrangement & investigation like thyroid function test, USG of the
thyroid, FNAC, preoperative S. calcium, and other investigation for general anesthesia will
be done. After completing the necessary procedure for operation, the patient will undergo
hemi/total thyroidectomy. Detailed operation findings, including the postoperative recurrent
laryngeal nerve evaluation, will be noted. All the patients undergoing surgery will be
evaluated with fiberoptic laryngoscopy (FOL) pre and post operatively to see the vocal cord
status.
All the information will be recorded in a preformatted questionnaire. The data will be
analyzed by computer-based software SPSS (26.0). The statistical significance will be set to
p< 0.05. Demographic characteristics and study variables will be analyzed using descriptive
statistics. The results of the study will be expressed as mean, standard deviation (± SD),
frequency, and percentages. Means and standard deviations will be reported for continuous
variables. Frequencies and percentages will be reported for categorical variables. Student's t-
test will be done to compare the continuous variables, and the Chi-Square test will be done to
compare the categorical variables.
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Surgical Method:
All cases will be operated under General anesthesia with endotracheal intubation. Neck will
be slightly hyperextended. A Kocher’s incision will be placed in a skin crease two
fingerbreadths above the sternal notch between the medial borders of the sternocleidomastoid
muscles. Subcutaneous fat and platysma are divided. Subplatysmal dissection plane will be
developed up to the level of the thyroid cartilage above, and the sternal notch below.
Separating strap muscles and exposing the anterior surface of the thyroid. The fascia between
the sternohyoid and sternothyroid muscles is divided along the midline with diathermy or
scissors. The infrahyoid strap muscles will be retracted laterally with a right-angled retractor.
The middle thyroid vein will be ligated. Ligate the superior thyroid artery near the external
branch of the superior laryngeal nerve. Will take great care to ligate the artery as close to the
thyroid parenchyma as possible so as to avoid injury to the nerve. The superior arterial
pedicle will be double ligated. The recurrent laryngeal nerves must remain undisturbed and
in situ. A negative drain tube will be kept in situ. The wound will be closed in a layer by
layer. In all cases, the specimen will send for histopathology.
Variables:
Demographic variables:
● Age
● Gender
Clinical variables:
● Benign
● Malignant
Outcome variables:
Recurrent laryngeal nerve injury
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Confounding variables:
● To minimize the biased interpretation of the data during analysis, confounding
variable, which may distort the study result, is taken into account. Associated
thyroiditis, the anatomical variation of the RLN. The size of thyroid swelling is a
confounding variable.
Research tools:
Operational Definition:
Total thyroidectomy: Removal of the entire thyroid gland. (Tongol and Mirasol, 2016).
Vocal Fold Paralysis: This pathological condition inhibits adequate closure of the vocal
in incomplete vocal fold closure and may inhibit propagation of a symmetrical and fluid
Data processing and analysis: The data will be analyzed by computer-based software SPSS
(26.0). The statistical significance will be set to p< 0.05. Demographic characteristics and
study variables will be analyzed using descriptive statistics. The results of the study will be
expressed as mean, standard deviation (± SD), frequency, and percentages. Means and
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standard deviations will be reported for continuous variables. Frequencies and percentages
will be reported for categorical variables. Student's t-test will be done to compare the
continuous variables, and the Chi-Square test will be done to compare the categorical
variables.
Ethical issue
In this study, keeping compliance with the Helsinki Declaration for Medical Research
Involving Human Subjects 1964, the nature and purpose of the study will be informed in
detail to all participants. Voluntary participation will be encouraged. There will be minimal
physical, psychological, and social risks to the subjects. Informed and understood written
consent will be taken from every patient before enrollment. Privacy, anonymity, and
confidentiality of data information identifying any patient will be maintained strictly. Each
patient will enjoy every right to participate or refuse or even withdraw from the study at any
point of time. Before starting this study ethical clearance will be taken from the Institutional
Review Board (IRB) of BSMMU. Data taken from the participants will be regarded as
confidential and kept locked under the investigator for purposeful use only. This protocol is
primarily selected by the academic committee of the department of otolaryngology and head-
neck surgery. Due respect will be given to all the subjects .
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The informed consent will contain the following information -
▪ Explanation of the nature and purpose of the study
▪ Explanation of the procedure, benefit, and duration of the study
▪ Full understanding of the results of this research and their probable welfare implications
▪ An explanation that they will have the right to refuse or to participate in the study ▪
Refusal to participate in the study will not affect the treatment given.
▪ Consent will be taken in an understandable local language from the study subjects before
enrollment
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of sample collection. Over the following three months, monthly discussions will be held on the
progress of data collection and any problems with regard to data collection will be identified and
solved. During the remaining three months, meetings will be held with the supervisor at weekly
intervals to go over the details of thesis writing and submission.
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Dummy Results:
Sex
Male
Female
Age, years
Preoperative diagnosis
Benign
Malignant
Data are expressed as number or as mean ± standard deviation
A p-value of ˂ 0.05 considered statistically significant
Table II: Comparison of type of surgery with RLN palsy patients (n=60)
Sex
Male
Female
Age, years
Type of Surgery
Hemi thyroidectomy
Total thyroidectomy
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