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\begin{document}

\title{Comparison Of Harmonic Scalpel, Coblation And Cold Dissection For
Tonsillectomy In Adult}



\author[1]{Xinqi Hu}%
\author[1]{Jiaying Li}%
\author[1]{Xidong Cui}%
\author[1]{Guangbin Sun}%
\affil[1]{Huashan Hospital Fudan University}%


\vspace{-1em}



  
  \date{May 24, 2024}


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\selectlanguage{english}
\begin{abstract}
Objectives: To compare the safety and effectiveness of tonsillectomy
with three different techniques. Design: A double-blinded randomized
prospective clinical trial Setting and Participants: Totally120 patients
with recurrent tonsillitis between April 2018 and April 2020 were
included. Main Outcome Measures: Operative time, intra and post
operative bleeding loss, pseudomembrane growth time, pseudomembrane
shedding time, postoperative pain, and necrosis depth of specimens were
compared of harmonic scalpel(HS), coblation and cold dissection(CD)
tonsillectomy. Results: The operative time and intraoperative bleeding
loss was significantly less in HS and coblation group than CD group(p
\textless{} 0.05). Pseudomembrane growth time and pseudomembrane
shedding time were significantly longer in the HS group compared with
the other groups(p \textless{} 0.05). The postoperative pain levels were
significantly higher on the first postoperative day in CD group(p
\textless{} 0.05), and significantly lower on the third and seventh
postoperative day in coblation group(p \textless{} 0.05). There was no
significant difference among three techniques in terms of postoperative
bleeding loss(p \textgreater{} 0.05). The deepest necrosis depth in
specimen was found in HS group(p \textgreater{} 0.05), while in CD
group, only edema was observed without necrosis. Conclusion: To compared
with HS and CD, coblation is a faster, safer and more painless technique
for tonsillectomy in adult.%
\end{abstract}%



\sloppy


\textbf{ABSTRACT}

\textbf{Objectives:} To compare the safety and effectiveness of
tonsillectomy with three different techniques.

\textbf{Design:} A double-blinded randomized prospective clinical trial

\textbf{Setting and Participants:} Totally120 patients with recurrent
tonsillitis between April 2018 and April 2020 were included.

\textbf{Main Outcome Measures:} Operative time, intra and post operative
bleeding loss, pseudomembrane growth time, pseudomembrane shedding time,
postoperative pain, and necrosis depth of specimens were compared of
harmonic scalpel(HS), coblation and cold dissection(CD) tonsillectomy.

\textbf{Results:} The operative time and intraoperative bleeding loss
was significantly less in HS and coblation group than CD
group(\emph{p}\textless{} 0.05). Pseudomembrane growth time and
pseudomembrane shedding time were significantly longer in the HS group
compared with the other groups(p \textless{} 0.05). The postoperative
pain levels were significantly higher on the first postoperative day in
CD group(\emph{p}\textless{} 0.05), and significantly lower on the third
and seventh postoperative day in coblation group(\emph{p} \textless{}
0.05). There was no significant difference among three techniques in
terms of postoperative bleeding loss(\emph{p} \textgreater{} 0.05). The
deepest necrosis depth in specimen was found in HS group(\emph{p}
\textgreater{} 0.05), while in CD group, only edema was observed without
necrosis.

\textbf{Conclusion:} To compared with HS and CD, coblation is a faster,
safer and more painless technique for tonsillectomy in adult.

\textbf{Abbreviations:} HS: harmonic scalpel; CD: cold dissection; VAS:
visual analogue scale

\textbf{Key point:}

\begin{itemize}
\tightlist
\item
  This study showed that different tonsillectomy techniques have an
  effect on operation and determine the extent of postoperation pain and
  patients' recovery time.
\item
  Analysis of research data showed that necrosis depth doesn't
  significantly correlate with postoperative pain. However,there was
  relation between necrosis depth and recovery time.
\item
  By analyzing the causes of postoperative secondary bleeding, and after
  tonsillectomy care is extremely important
\item
  HS and coblation tonsillectomy had significantly shorter operative
  time and less intraoperative bleeding.
\item
  Coblation is a faster, safer and more painless technique for
  tonsillectomy in adult.
\end{itemize}

\textbf{Introduction}

Tonsillectomy is one of the most common procedure in
Otorhinolaryngology, and it is recommended when the following standard
is met: more than seven episodes in the prior year, or more than five
episodes annually in the past 2 years, or more than three episode in the
past 3 years(1). Although tonsillectomy is considered a simple
procedure, how to further improve its safety, efficiency, painlessness
and operability is still a concern. The efficacy of different
tonsillectomy techniques is controversial.

HS uses ultrasonic waves to vibrate the knife head, vaporize the fluid
in the tissue, denature and coagulate the protein in the cell, and
produce hemostatic effect while cutting the tissue(2). Coblation uses
the formation of a plasma thin layer in a plasma radio frequency
electric field. The charged particles in the plasma thin layer are
accelerated to dissociate the molecular bonds in the tissue and form
carbohydrates and oxides. Under relatively low temperature conditions
(40-70) to achieve the purpose of ablation and coagulation(3).

The aim of this study is to comapre postoperative pain score and
postoperative bleeding loss of HS, coblation and CD tonsillectomy to
select the surgical technique with the least complications and to
explore the best tonsillectomy technique in adult in terms of operative
time, intraoperative bleeding loss, pseudomembrane growth and shedding
time, and necrosis depth of specimen.

\textbf{Method}

A double-blinded randomized clinical trial was conducted and included
120 patients aged 18 to 65 years with recurrent tonsillitis from April
2018 to April 2020 were recruited for tonsillectomy and randomly divided
into 3 groups.

Ethical considerations

This study's approval was obtained by the Ethics Committee of ``Blinded
for review''.According to the Chinese law and the guidelines of the
research ethics committee, all patients gave informed consent of
allowing randomization prior to operation.

Rondomization

Patients were divided into three groups randomly by using random number
table prepared and managed by a nonblinded nurse. All information was
stored separately and only was available for emergency situations.

Operative technique

All operations was performed by the same surgeon under general
anesthesia. We performed 40 HS tonsillectomy using a high-intensity
focused ultrasound machine(Johnson \& Johnson,New Brunswick,USA) at the
level of 5 in dissection and 3 in haemostasis, performed 40 coblation
tonsillectomy using EVac Xtra HP type knife head connected to Coblate II
Surgical System(ArthroCare Corp,Austin,USA) at the level of 7 in
ablation and 3 in coagulation, and performed 40 CD tonsillectomy using
sickle-shaped knives and bipolar electrocautery.

All patients were not given antibiotics, hemostatic drugs or other drugs
after surgery. Patients were given a cold liquid diet in three days
after the operation, and a cold semi-liquid diet in 14th postoperative
day.

Examination methods

The removed tonsils immersed in 10\% formalin solutionwere divided into
parts passing through the upper and lower pole, and were fixed in a
paraffin block by the same operator. The paraffin block-was made into
4-5 micron sections and stained with hematoxylin--eosin method. The
pathological section was photographed by KF-PRO-120 digital pathology
panoramic scanner(KFBIO,Yuyao,China), and the necrosis depth was
measured by K-Viewer software(KFBIO,Yuyao,China).

Evaluation methods

All patients were hospitalized for seven days after surgery and
telephoned for follow up. The operative time was recorded from cutting
mucosa to finishing hemostasis. Postoperative pain was recorded through
visual analogue scale (VAS) at 8 AM on the first, third, seventh and
fourteenth postoperative days. Pain severity was scored from 0 to 10,
which 0 means no pain and 10 means the most severe pain(4).

The pseudomembrane growth and shedding time were observed and recorded
by the same observer at 8 AM every morning. The pseudomembrane growth
time was recorded as tonsil fossa was completely covered by white
fibrous membrane. The time when the white fiber membrane completely
falls off is the pseudo-membrane fall off time.

Intraoperative bleeding loss is calculated by fluid volume of suction
bottle and the weigh of cotton ball pre and post the surgery. Record
whether the patient has bleeding from the first day to the fourteenth
day after surgery.

Statistical methods

Statistical Package for the Social Sciences version 26(SPSS 26.0,IBM
Corp, Armonk, New York, USA) was used for data analysis. Before starting
the analysis, the continuous variable were tested for normality
(Shapiro-Wilk test) and homogeneity of variance test (Levene's test).
The result shows that all continuous variables do not conform to normal
distribution or homogeneity of variance. Kruskal-Wallis test was applied
as parametric tests for comparison of data. A \emph{p} value less than
0.05 was considered statistical significance. Frequency distribution is
given for categorical variables and discrete variables, expressed as a
percentage. Chi-square test were applied for categorical variables and
discrete variables with 95\% confidence level.

\textbf{Results}

120 patients all completed the 14-day follow-up. There are 40 patients
in each group, including 20 males and 20 females. There was no
statistically significant difference in the rate of age or gender
between the three groups(\emph{p} \textgreater{} 0.05)(Table 1).

Pain score

The CD group(6.4( 95 per cent CI, 6.11 to 6.59)) showed significantly
higher pain scores than other two groups on the 1st postoperative days
(p \textless{} 0.05), and no statistically significant difference was
showed between HS group(5.7( 95 per cent CI, 5.47 to 5.88)) and
coblation group(5.7( 95 per cent CI, 5.45 to 5.85)) (p \textgreater{}
0.05). Patients of cobation group(3.05( 95 per cent CI, 2.80 to 3.30),
1.33( 95 per cent CI, 1.17 to 1.48), respectively) showed significantly
lower pain scores than HS group(3.75( 95 per cent CI, 3.50 to 4.00),
1.60( 95 per cent CI, 1.43 to 1.77), respectively) and CD group(4.08( 95
per cent CI, 3.83 to 4.32), 1.70( 95 per cent CI, 1.51 to 1.89),
respectively) on the 3th and 7th postoperative days(p \textless{} 0.05).
There was no statistically significant difference in patients' pain
scores among three groups on the 14th postoperative day(p \textgreater{}
0.05) (Figure 1).

Postoperative bleeding

No case of primary bleeding was reported. Two cases of secondary
bleeding occured in each group. Most patients occured secondary bleeding
after eating hard food for about a week after surgery(Table 2).

Operative time

The operative time of CD group(57.3min) was significantly longer than
other two groups(\emph{p} \textless{} 0.05). There was no statistically
significant difference between HS group(20.9min) and coblation
group(22.2min)(\emph{p} \textgreater{} 0.05)(Figure 2A).

Intraoperative bleeding

The mean intraoperative bleeding loss in CD group (70.5ml) was
significantly more than that in HS group(3.5ml) and coblatin
group(5.9ml)(\emph{p} \textless{} 0.01). The Intraoperative bleeding
loss of HS group and coblation group showed no statistically significant
difference(\emph{p} \textgreater{} 0.05)(Figure 2B).

The pseudomembrane growth and shedding time

The pseudomembrane growth and shedding time in the HS group were
significantly longer than the other two groups(p \textless{} 0.05).
Although there was no statistically significant difference, the
pseudomembrane growth and shedding time in the CD group were longer than
the coblation group(Figure 3A,3B).

Necrosis depth

The depth of scar tissue produced by thermal injury is used as the
standard for the necrosis depth during tonsillectomy. The mean necrosis
depth in HS group was 767.5\selectlanguage{greek}μ\selectlanguage{english}m. In coblation group, the mean necrosis
depth was 447.1\selectlanguage{greek}μ\selectlanguage{english}m. In CD group, there was a little inflammatory cell
infiltration in the tonsil tissue without thermal injury, but the
interstitial edema was severe, and small blood vessels were
dilated(Figure 4). The necrosis depth was statistically different
between three groups(p \textless{} 0.05)

\textbf{Discussion}

Tonsillectomy is one of the most common operations in otolaryngology and
the number is increasing per year over recent decades(5). In the past
century, a variety of modern techniques have emerged to replace
traditional CD tonsillectomy to make the surgery more fast, safe, and
efficient.

Postoperative pain is the main factor affecting patients' quality of
life of in the short-term. Although the VAS score of the CD group was
significantly higher than other two groups on the1st postoperative day,
the VAS score of the HS group was higher than the other two groups on
the 3rd and 7th postoperative day, and the VAS score of coblation group
was lower throughout the recovery period. We believe that coblation
tonsillectomy has lower postoperative pain compared with HS and CD
tonsillectomy. There are many factors that affect the level of
postoperative pain in patients. Ragabet al. reported that higher VAS
scores in CD group on the first day after surgery may be related to more
intraoperative bleeding resulting in unclear operation fields and longer
operation time(6). Postoperative pain is mainly caused by inflammation,
tissue damage and stimulation of mucous membranes, muscles, and nerve
endings by mechanical movements such as swallowing. HS tonsillectomy has
more severe thermal damage, leading to more obvious inflammation and a
slower recovery rate. Coblation tonsillectomy reduces both
intraoperative mechanical and thermal injury, which leads to
lesspostoperative pain. Mitic et al. reported that coblation
tonsillectomy has less postoperative pain than CD tonsillectomy(7).
Polites et al. reported that the application of coblation tonsillectomy
on only the first three days after surgery has less postoperative pain
than CD tonsillectomy(8).

According to the results of our study, two cases of secondary bleeding
occured in each group. It is worth noting that the mean time to occur
secondary bleeding was 7.8th days after surgery in the three groups. As
epithelial cells grow inward from the wound edge, the epithelial
contracture causes the fibrinous clot to separate and expose the
granulation tissue on the 7th day after surgery(9). Meantime, as
patient's pain getting greatly reduced, patients are eager to return to
a normal diet, subconscious mechanical stretching is more likely to
cause secondary bleeding. The stimulation of repeated inflammation can
cause necrosis and fibrosis of the surrounding tissues to make the
tonsils adhere to the surrounding tissues(10, 11), and because of the
large diameter of blood vessels in the lower tonsils, bleeding is more
dangerous if they occur. In order to avoid severe bleeding, we suggest
that active postoperative care and surgical proficiency are very
important, the tonsils should be carefully separated along the capsule,
especially the lower pole of the tonsils.

To compared with CD tonsillectomy, both HS tonsillectomy and coblation
tonsillectomy can significantly reduce operative time and intraoperative
bleeding loss, which is also recognized by many other scholars(6, 12,
13).

Pseudomembrane is a fibrin clot that includes inflammatory cells and
bacteria(14). HS tonsillectomy has high thermal damage to the tissue.
The heat energy denatures the collagen in the tissue, and the
pseudomembrane is thicker, which makes the pseudo-membrane grow and fall
off time for a longer time(15).

Our study shows that HS tonsillectomy has stronger thermal damage to
tonsil tissue, while CD tonsillectomy has no thermal damage. The
necrosis depth is not related to postoperative pain and postoperative
bleeding rate. Bo\selectlanguage{polish}ğ\selectlanguage{english}rul et al. reported that necrosis depth was positively
correlated with the degree of postoperative pain(16). However, we
believe that the necrosis depth is related to the healing time of
surgery.

\textbf{Conclusion}

Coblation tonsillectomy have obvious advantages in respect of operation
time, intraoperative bleeding loss,postoperative pain and healing time.
We suggest that postoperative care and surgical proficiency are crucial
factors affecting postoperative secondary bleeding. Although it has not
been proved that the necrosis depth is related to postoperative pain,
the results showed that the necrosis depth was negatively correlated
with the healing time.

\textbf{References}

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2 McCarus S D. Physiologic mechanism of the ultrasonically activated
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3 Pynnonen M, Brinkmeier JV, Thorne MC, Chong LY \& Burton MJ. Coblation
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4 Gallagher EJ, Liebman M \& Bijur PE. Prospective validation of
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5 Erickson BK, Larson DR, St Sauver JL, Meverden RA \& Orvidas LJ.
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7 Mitic S, Tvinnereim M, Lie E \& Saltyte BJ. A pilot randomized
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13 Sheahan P, Miller I, Colreavy M, Sheahan JN, McShane D \& Curran A.
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15 JOHN L, WILLIAM F \& DAVID J. T. A comparison of mucosal incisions
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16 Bo\selectlanguage{polish}ğ\selectlanguage{english}rul MF, \selectlanguage{ngerman}Ünal A, Y\selectlanguage{polish}ı\selectlanguage{english}lmaz F, Sancaktar ME \& Bak\selectlanguage{polish}ı\selectlanguage{english}rta\selectlanguage{polish}ş \selectlanguage{english}M. Comparison
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2019\textbf{276} .

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