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\begin{document}

\title{Application of local flipped pedicle microflap combined with botulinum
toxin A injection in the treatment of refractory laryngeal contact
granuloma}



\author[1]{Zihui Sun}%
\author[2]{Mingjing Cai}%
\author[1]{Kangjun Hu}%
\author[2]{Yanyan Ren}%
\author[3]{Guangfei Li}%
\author[1]{Qingxiang Zhang}%
\author[1]{Shuangba He}%
\affil[1]{Nanjing Tongren Hospital}%
\affil[2]{Nanjing Tongren hospital}%
\affil[3]{Nanjing Tongren Hospital, Southeast University}%


\vspace{-1em}



  
  \date{May 27, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Objective Laryngeal contact granuloma (LCG) is a kind of benign lesion
that related with improper use of voice, habitual throat clearing and
laryngopharyngeal reflux. Under 3 months standardized treatment, those
who have no improvement or disease recurrence are called refractory LCG.
The purpose of this study was to explore an advanced surgical method
with local flipped pedicle microflap combined with botulinum toxin A
injection in the treatment of refractory LCG. Design A retrospectively
analysed of totally 11 patients with refractory LCG from January 2018 to
December 2020. After CO2 laser granuloma resection with local flipped
pedicle microflap combined with botulinum toxin A injection, the
patients were followed up at 1, 3, 6 and 12 months after operation to
evaluate the effect of the surgery. Descriptive statistical methods were
used to analyze and summarize the improvement of postoperative symptoms
and signs of laryngoscope. Results During follow-up, 4 of 11 patients
had residual pseudomembrane under the electronic laryngoscope, and had
smooth mucosa when subsequent follow-up. The remaining 7 cases of
electronic laryngoscope granuloma disappeared. Up to now their symptoms
disappeared, and there were no systemic and local complications.
Conclusion CO2 laser granuloma resection with local flipped pedicle
microflap combined with botulinum toxin A injection can achieve the
lesion clearance, restore the integrity of vocal fold cover-body,
preserve the perichondrium, and reserve a time window for microflap
recovery. It is based on the principle of preserving normal mucosa, with
high cure rate and no recurrence. It is worthy of clinical promotion.%
\end{abstract}%



\sloppy


\textbf{Application of local flipped pedicle microflap combined with
botulinum toxin A injection in the treatment of refractory laryngeal
contact granuloma}

\textbf{Running title: The application of flipped pedicle microflap in
refractory laryngeal contact granuloma}

\textbf{ABSTRACT}

\textbf{Objective} Laryngeal contact granuloma (LCG) is a kind of benign
lesion that related with improper use of voice, habitual throat clearing
and laryngopharyngeal reflux. Under 3 months standardized treatment,
those who have no improvement or disease recurrence are called
refractory LCG. The purpose of this study was to explore an advanced
surgical method with local flipped pedicle microflap combined with
botulinum toxin A injection in the treatment of refractory LCG.
\textbf{Design} A retrospectively analysed of totally 11 patients with
refractory LCG from January 2018 to December 2020. After
CO\textsubscript{2} laser granuloma resection with local flipped pedicle
microflap combined with botulinum toxin A injection, the patients were
followed up at 1, 3, 6 and 12 months after operation to evaluate the
effect of the surgery. Descriptive statistical methods were used to
analyze and summarize the improvement of postoperative symptoms and
signs of laryngoscope. \textbf{Results} During follow-up, 4 of 11
patients had residual pseudomembrane under the electronic laryngoscope,
and had smooth mucosa when subsequent follow-up. The remaining 7 cases
of electronic laryngoscope granuloma disappeared. Up to now their
symptoms disappeared, and there were no systemic and local
complications. \textbf{Conclusion} CO\textsubscript{2} laser granuloma
resection with local flipped pedicle microflap combined with botulinum
toxin A injection can achieve the lesion clearance, restore the
integrity of vocal fold cover-body, preserve the perichondrium, and
reserve a time window for microflap recovery. It is based on the
principle of preserving normal mucosa, with high cure rate and no
recurrence. It is worthy of clinical promotion.

\textbf{KEY POINTS}

\selectlanguage{ngerman}·In recent years, a complete cure of the disease is still a huge
challenge for ENT doctors.

\textbf{·} This advanced surgical method are more suitable for the those
refractory LCG who have no response to the standardized medical
treatment and voice correction for 3 months.

\textbf{·} Application of local flipped pedicle microflap combined with
botulinum toxin A injection in the treatment of refractory LCG is
effective and safe.

·Based on the principle of preserving normal mucosa, the surgery can
achieve the lesion clearance, restore the integrity of vocal fold
cover-body, preserve the perichondrium, and reserve a time window for
microflap recovery.

·Precision operability with great patience and caution is needed in the
surgery. The microflap tension should be appropriate, the torsion or
fenestration should be prevented from necrosis of the mucosa, and the
fully mucosal coverage of the surgical wound is the key to the success
of the operation.

\textbf{KEY WORDS} granuloma; larynx; CO\textsubscript{2} laser;
microflap; botulinum toxin

\textbf{INTRODUCTION}

LCG, is a kind of benign lesion that occurs around the vocal fold mucosa
and presents ulcer and granulation tissue hyperplasia, which is easy to
relapse and difficult to cure radically. After standardized treatment
for more than 3 months, those who still have no improvement or disease
recurrence are called refractory contact granuloma\textsuperscript{1}.
LCG usually associated with several etiological factors such as
laryngopharyngeal reflux, habitual throat clearing and improper use of
voice. Thought the disease is not completely clear, it is usually
considered that mucosal inflammation and ulceration that occur the
posteromedial aspect of the vocal cords followed by granulation tissue
hyperplasia\textsuperscript{2}.Intubation granuloma is self-limited,
caused by endotracheal intubation, and totally different from laryngeal
contact granuloma. Very few of the intubation granuloma could not heal
spontaneously, and surgery may resolve it well with low recurrence rate.

Conservative treatment and surgical treatment have been widely used in
contact granuloma, but almost both treatments cannot form consensus to
overcome the persistence and recurrence contact granuloma. Granulomas
cause psychological trauma and anxiety in patients, leading to loss of
interest in peripheral events\textsuperscript{3}.In this article
advanced surgical methods with mucosal-flap and botulinum toxin A
injection are applied in the treatment of refractory LCG, with
significant efficacy and extremely low recurrence rate.

\textbf{MATERIALS AND METHODS}

\textbf{1 Material}

A retrospective analysis of a totally 11 patients with confirmed LCG
admitted to the Department of Otolaryngology Head and Neck Surgery of
our hospital from January 2018 to December 2020, and no significant
improvement after 3 months of~standard treatment with proton pump
inhibitors (PPI). Among them including 10 males and 1 female, aged from
24 to 63 years, with an average of 39.6 years. The course of disease
ranged from 5 to 48 months, with an average of 25.5 months. 5 patients
had one operation history and 1 patient had two operation history. The
main symptoms were hoarseness in 6 cases, cough in 3 cases, foreign body
sensation in throat in 1 case and dysphonia in 1 case.

\textbf{2 Operation method}

All 11 patients underwent general anesthesia and endotracheal
intubation. In the supine position, the operative cavity was exposed
under the supporting laryngoscope (Karl Storz, Germany). Under the
microscope, the lesions were removed along the pedicle of granuloma with
2W CO2 laser, and the carbon scab was completely removed and the
bleeding was fully stopped~by cold instruments or
CO\textsubscript{2}~laser. Local infiltration anesthesia with 2\%
epinephrine saline was applied to the affected ventricular band. The
diameter of the wound was measured and the 1.5 times of the diameter of
the pedicled mucosal flap was obtained from the affected ventricular
band with scissors. The pedicle was left behind the ventricular band and
rotated 90 degrees to cover the wound of granuloma. 7-0 vicryl
absorbable suture was used to intermittently suture 3-5 needles between
the free merge of the mucosal flap and the normal mucosa around the
vocal fold wound to make sure that the surface of the mucosal flap is
smooth without warping, the wound is completely covered, the pedicle is
not twisted, and the tension is moderate (Figure 1). 2U Botulinum toxin
A was injected into the middle part of bilateral vocal cords at the end
of operation. The excised granuloma lesions were sent for pathological
examination. After the operation, antibiotics and aerosol inhalation
were given for 3 days, and the sound was silenced for 2 weeks, and
correct the bad living habits. All 11 patients were treated with PPI for
8 weeks postoperatively.

\textbf{3 Effect evaluation and Statistical analysis}

At 1, 3, 6, and 12 months after the operation, the symptom improvement
of the subjects was tracked and recorded, and the physical signs of the
electronic laryngoscope or dynamic laryngoscope were recorded.
Descriptive statistical methods were used to analyze and evaluate
postoperative effects.

\textbf{Result}

All 11 patients underwent surgery and perioperative education without
any local or systemic complications. During the follow-up, there were 4
cases of residual pseudomembrane observed under the electronic
laryngoscope, of which 2 cases appeared in 1 month postoperatively, and
2 cases in 3 months after surgery. After 8 weeks of oral PPI treatment,
3 cases of mucosa recovered smooth when follow-up again, 1 case became
smooth mucosa when the third follow-up. There were no relapse in the
next follow-up. The remaining 7 cases of granuloma disappeared under the
electronic laryngoscopy. After an average of 6.2 months, all patients
preexisting symptoms such as hoarseness, foreign body sensation in the
throat, and coughing, and laryngoscopic signs were eventually clinically
cured (Figure 2).

\textbf{DISCUSSION}

Contact granuloma, also called larynx contact ulcer or vocal process
granuloma\textsuperscript{4}. It is reported that the incidence of the
contact ulcer is approximately 0.9\%-2.7\% in voice
disorders\textsuperscript{5}. It is more common in man than woman, more
precisely, man suffer 2\textasciitilde{}9 times large than woman among
the disease\textsuperscript{\textbf{6}} . The lesions usually appear in
unilateral vocal folds and sometimes bilateral vocal folds, and
typically in term of nodularation and epithelial ulceration of varying
degrees. The diagnosis of granuloma is very easy, generally based on
symptoms and laryngoscopy without biopsy, which is different from
laryngeal cancer. Pathologically, contact granuloma is not true
granuloma that because of lacking in cluster of mononuclear and
multinucleated histiocytes. They usually manifested as infiltration of
inflammation cells, capillary proliferation and fibrosis, and sometimes
as epithelial hyperplasia and perichondrium
keratosis\textsuperscript{7}.According to a grading system by Farwell et
al\textsuperscript{8}, clinical manifestations of the patient may be
asymptomatic or have varying degrees of voice disturbance, throat edema,
and varying levels of laryngeal discomfort and breathing difficulties.

Contact granuloma is always considered idiopathic when the common causes
like laryngopharyngeal reflux and anesthesia intubation are eliminated,
and some other causes are no-good habits of voice like incorrect
phonation and habitual throat clearing. That's to say, The mechanical
irritation caused by bilateral vocal fold collision and the inflammation
caused by gastric acid reflux cause direct damage to the vocal fold
mucosa\textsuperscript{9}. meanwhile, Smoking, inflammation, allergic
reaction, postnasal drip and social psychological pressure are also
important inducing factors of granuloma\textsuperscript{10}. Only a few
patients can determine the reasons through application of reflux symptom
index and reflux finding score, and pharyngo-oesophageal 24-h pH
monitoring. The complexity of the causes makes the treatment difficult
and controversial. The current treatment for LCG mainly includes voice
correction, medication, surgical treatment and vocal fold injection.
Empirically, voice therapy and PPI is its first-line
treatment\textsuperscript{11}. During the treatment cycle, patients are
instructed to silence their voices, try to avoid unconscious throat
clearing and coughing, and change incorrect phonation. At the same time,
patients need to improve their lifestyles to reduce laryngopharyngeal
reflux, including losing weight, reducing the amount of meals, and
avoiding lying down within 3 hours after eating, adhering to a low-fat
and low-acid diet, and avoiding intake carbonated or caffeinated
beverages and spicy stimulation food.

PPI are effciency in contact granuloma even though the patient do not
combined with laryngopharyngeal reflux\textsuperscript{12}. However, the
treatment cycle of internal medicine is very long, and the average
treatment period is about 4.7 months\textsuperscript{13}. Some patients
may experience gastrointestinal disorders such as diarrhea, nausea,
abdominal pain, or lack of gastric motility such as flatulence and
constipation or other symptoms. The recurrence rate up to 12.12\% when
recurrent patient received PPI, and 3\% even though combined with
injection corticosteroids into granuloma\textsuperscript{14}.

Surgical treatment is usually considered in the case of drug treatment
failure or recurrence granuloma. Surgical removal were not recommended
by some researchers because of it can shrink the size of the granuloma
in the short term but has high rate of recurrence in the long
term\textsuperscript{11}. An recent study indicate that The initial
non-surgical treatment (67 percent) has a much higher cure rate than
surgical treatment (30 percent) in contact granuloma
patients\textsuperscript{9}. Jingyi Wu reported that given postoperative
radiotherapy within 24 hours can reduce the recurrence of laryngeal
granuloma effectively\textsuperscript{15}. Vojko Djukic have studied
that Zinc supplementation for the treatment of granuloma of the larynx
is one of the conservative treatment\textsuperscript{16}. Zinc affects
the healing process of wounds though the exact mechanism is unclear.

From Q Pham, botulinum toxin A injection threaten the powerful collision
and adduction of posterior portion larynx via relaxing lateral
cricoarytenoid muscle\textsuperscript{17}. The collision of bilateral
arytenoid cartilage can cause local cartilage inflammation, mucosal
ulcers, and granulation tissue hyperplasia. Therefore, botulinum toxin A
injection can temporarily act on the denervated vocal fold muscles,
reducing the strong collision of the bilateral vocal folds and promoting
the repair of the vocal fold mucosa. The team's previous research showed
that surgery combined withbotulinum toxin A injection is highly
effective in voice disorders\textsuperscript{18}. A series of studies
also show that botulinum toxin A injection is safe and effective in the
treatment of LCG\selectlanguage{english}\textsuperscript{17,19}. Botulinum toxin A injection
broaden the structure of the granuloma strategy from a chemical point of
view for the first time and transfer to innervated muscles and can be
alternative therapy under patients' choice and institution's situation
or applied to the failure on voice therapy or PPI
\textsuperscript{17,20}.

The recurrence and refractory of LCG has always been the clinical focus
of attention of otolaryngologists. Regardless of the surgery strategy,
CO2 laser, angiolytic potassium titanyl phosphate laser or cold
instrument resection, it is difficult to achieve the desired effect in
the operation to remove the lesion alone. In this study, the pedicled
mucosal flap of ventricular band was transferred to the wound after
laser resection of granuloma, and the mucosa was anastomosed by
microsurgery. This is an update of the traditional operation of Ni Xin
et al\textsuperscript{21}and solves the problem that the released
mucosal margin of the wound cannot completely cover the fresh wound,
which may resulting in easy recurrence. In this study, no matter the
size of granulomatous wound, we can take the pedicled mucosal flap to
completely close the wound, which eliminates the potential pathological
basis of granulomatous inflammation and achieves the purpose of one-time
basic cure. The acquisition and transfer of mucosal flap follows the
principle of voice surgery, staying in as a superficial plane as
possible and preserving the normal mucosa. It not only completely
excises the lesion, but also limits the lesion wound to the root of
granuloma, and completely reconstructs the cover-body of vocal fold
(epithelium plus superficial lamina propria), which is conducive to the
recovery of vocal fold mucosal wave and the prevention of local scar or
stenosis. At the same time, assisted microsurgery can avoid mucosal
avulsion and displacement, accelerate fibrosis of the mucosal flap wound
and granuloma wound. Secondly, the choice and acquisition of mucosal
flap is minimally invasive, easy to obtain and survive, which avoids
open surgical trauma and increases the survival rate of mucosal flap.
Recently, the combined treatment of vocal fold granuloma has
significantly improved the efficiency compared with the single
treatment, and has gradually become a trend \textsuperscript{14,13,}
\textsuperscript{22}. This method combined with botulinum toxin A
injection reserve a time window for the recovery of mucosal flap, also
help to correct the phonation model and stabilize the surgical effect.
Postoperative PPI therapy is an important step to consolidate the
curative effect, control potential gastric acid reflux and avoid
recurrence. It can be seen that the concept of combined treatment of LCG
retains the advantages of various treatment methods, which is of great
significance for the thorough treatment of the disease, and is an
undeniable trend in the treatment of contact granuloma.

Precision operability with great patience and caution is needed in the
surgery. The width of the pedicle should not be less than half of its
length in theory, so that the flap can survive. When suturing, the
surgeon should pay attention to the position of the needle and the
control of the wrist strength, the tension should be appropriate, the
torsion or fenestration of the pedicle of the microflap should be
prevented from necrosis of the mucosa, and the fully mucosal coverage of
the surgical wound is the key to the success of the operation.
Furthermore, experienced anesthesiologists will use a smaller diameter
endotracheal tube to expose the surgical field more clearly. At the same
time, when the glottis is exposed by endotracheal intubation, surface
anesthesia will be combined to reduce the fluctuation of vital signs and
hemodynamics during the operation.

After standardized medical treatment and voice correction for 3 months,
there was no significant improvement in refractory LCG. It was suggested
that local pedicled mucosal flap transfer combined with botulinum toxin
A injection should be performed. As a preliminary study, there were no
systemic or local complications, high cure rate and low recurrence rate.
The cure of the disease also inspired the treatment of vocal fold scar,
adhesion, laryngeal stenosis, etc. we will continue to further clinical
observation and including more patients.

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\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image1/image1}

\end{center}
\end{figure}

FIGURE 1 Intraoperative condition. A. Contact granuloma under the
microscope of laryngoscope; B. After CO2 laser resection of granuloma;
C. The pedicle microflap covered the wound; D. After mucosal flap
sutured\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image2/image2}

\end{center}
\end{figure}

FIGURE 2 The vocal folds were observed by electronic laryngoscope. A.
There was contact granuloma in the left vocal fold before operation; B.
At 1 day after operation, the vocal folds showed that the pedicle
microflap covered the wound well; C. 1 month after operation, the wound
was smooth with residual pseudomembrane; D. At 12 months after
operation, the mucosa of biliteral vocal folds were smooth under
electronic laryngoscope\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Fig/Fig}

\end{center}
\end{figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Fih/Fih}

\end{center}
\end{figure}

\selectlanguage{english}
\FloatBarrier
\end{document}

