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\begin{document}

\title{Stapler Closure versus Manual Closure in Total Laryngectomy for
Laryngeal cancer: A Systematic Review and Meta-Analysis}



\author[1]{Yi-Chan Lee}%
\author[2]{Tuan-Jen Fang}%
\author[3]{ I-Chun Kuo}%
\author[4]{Yao Te Tsai}%
\author[2]{Li-Jen Hsin}%
\affil[1]{Chang Gung Memorial Hospital Keelung Branch}%
\affil[2]{Chang Gung Memorial Hospital Linkou Main Branch}%
\affil[3]{Chang Gung Memorial Hospital Linkou Branch}%
\affil[4]{Chang Gung Memorial Hospital Chiayi Branch}%


\vspace{-1em}



  
  \date{May 30, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Abstract Objective: Total laryngectomy (TL) is a life-saving procedure
for individuals with advanced laryngeal cancer or those suffering from
recurrence after initial treatment. The present study aims to evaluate
the differences between stapler closure (SC) and manual closure (MC) of
the pharynx during TL for patients with laryngeal cancer.
Design/Setting: A systematic literature search was performed using the
PubMed, Embase and Cochrane Library. The data were analyzed using
Comprehensive Meta-Analysis software (Version 3; Biostat, Englewood,
NJ). Dichotomous data were calculated by odds ratio (OR) and continuous
data were calculated by mean difference (MD) with 95\% confidence
intervals (CI). Main outcome/Results: A total of 7 studies (535
patients) were included in this meta-analysis. Pooled analysis showed
that the operative time of TL was significantly reduced in the SC group
(MD, -63.2; 95\% CI, -106.0 to -20.4). Moreover, the SC group had a
lower incidence of pharyngocutaneous fistula (OR = 0.38; 95\% CI,
0.18-0.83; P = 0.016) and hospital stay (MD, -2.9; 95\% CI, -5.6 to
-0.1). The incidence of postoperative surgical site infection
(OR = 0.41; 95\% CI, 0.02-8.73; P = 0.565) was comparable between the
two groups. Conclusion: Based on these results, SC may be a useful
option for patients who need TL.%
\end{abstract}%



\sloppy




\textbf{1 Introduction}

The role of radiation-based therapy in laryngeal cancer has been well
established by several prospective randomized
trials\textsuperscript{1-3}. However, total laryngectomy (TL) is still
one of the treatment options for advanced cases or when the disease
fails to respond to initial organ preservation therapy. One of the
critical steps in TL is the closure of the pharyngeal mucosa after the
removal of the entire larynx. Adequate pharyngotomy closure should be
tension-free and watertight to prevent leakage. In addition, the
viability of the pharyngeal mucosa needs to be maintained as much as
possible. Manual suturing by hand, though time-consuming, is the
technique traditionally used for pharyngeal closure after TL. Since the
development of surgical staplers in 1908, these mechanical suturing
devices have been increasingly used to connect tissue in a sterile and
efficient way\textsuperscript{4}. Surgical stapler closure of the
pharyngeal defect after laryngectomy was first reported in 1971 by a
Russian study\textsuperscript{5}. Several authors subsequently reported
their experiences comparing the differences between manual closure (MC)
and stapler closure (SC) of the pharyngeal defect after TL. The purpose
of the present study was to compare intraoperative and postoperative
parameters between SC and MC in total laryngectomy for laryngeal cancer
in the existing English literature.

\textbf{2 Methods}

2.1 Literature search

This present analysis was conducted according to the Preferred Reporting
Items for Systematic Reviews and Meta-Analyses
statement\textsuperscript{6}. Two of the authors (YCL and LJH) searched
PubMed, EMBASE, and the Cochrane Library independently and extensively
for articles of interest published before March 2020. The keywords used
in the search process included ``stapler'' or ``stapling'' or
``mechanical'' and ``laryngectomy''. Moreover, reference lists of the
included studies were also reviewed to identify additional studies.

2.2 Study selection and data extraction

The inclusion criteria were studies including only patients with
laryngeal cancer who underwent TL, articles published in English, and
studies comparing the outcomes of TL between the SC and MC techniques.
The exclusion criteria were based primarily on the absence of one of the
inclusion criteria. Studies without a control group, studies using the
same database, articles not published in English, duplicate studies,
case reports, abstracts, letters to the editor, and articles pending
publication of the full text were excluded from the present analysis.
Data were independently extracted by the 2 researchers (YCL and LJH).
The bias in the studies was assessed independently by two researchers
(YCL and LJH) using the Newcastle-Ottawa Scale and the Cochrane
Collaboration's risk of bias tool (RoB 1.0) for nonrandomized and
randomized studies, respectively \textsuperscript{7,8}. Discrepancies in
study bias classification were discussed between the two authors until
consensus was achieved.

2.3 Outcomes

The main outcomes of this study included operative time,
pharyngocutaneous fistula (PCF), length of hospitalization and
postoperative surgical site infection.

2.4 Data analysis

The results were analyzed using Comprehensive Meta-Analysis software
(Version 3; Biostat, Englewood, NJ). Mean differences (MDs) were
calculated to compare the operative time and the length of
hospitalization between the SC and MC groups. Odds ratios (ORs) were
calculated to compare the PCF rate and postoperative surgical site
infection rate between the SC and MC groups. The overall effect was
pooled using a random-effects model. Statistical heterogeneity among
studies was measured using the \emph{I\textsuperscript{2}} statistic,
which calculated the proportion of overall variation attributable to
between-study heterogeneity. An \emph{I\textsuperscript{2}} statistic
exceeding 50\% indicated moderate heterogeneity, and
an\emph{I\textsuperscript{2}} statistic exceeding 75\% indicated high
heterogeneity \textsuperscript{9}. Potential publication bias was
assessed using a funnel plot and the Egger intercept
test\textsuperscript{9}. A 2-sided \emph{P} value \textless{} 0.05 was
considered statistically significant.



\textbf{3 Results}

3.1 Study selection

The initial literature search yielded a total of 240 articles. Studies
that were duplicated were excluded. Four articles were also excluded
based on their titles and abstracts. The remaining 54 potentially
eligible studies were retrieved for a careful review of the full texts.
Among them, studies without a control group, review articles, studies
with the same database, studies including non-laryngeal cancer patients,
studies with unclear inclusion criteria and studies not written in
English were excluded from the analysis. Finally, 7 articles were
included in this review \textsuperscript{10-16}. A flow diagram
describing the process involved in study identification and
inclusion/exclusion is shown in \textbf{Figure 1} . \textbf{eTable 1} in
the \emph{Supplement} summarizes the literature search process and the
keywords used.

3.2 Demographics

\textbf{Table 1} lists the basic demographics of patients from the 7
articles, including two randomized studies and 5 nonrandomized studies.
The pooled prevalences of preoperative tracheostomy and radiotherapy
were both significantly higher in the SC group (\emph{P} =0.04
and\emph{P} =0.00, respectively). The bias assessment for each study is
described in \textbf{eTable 2 and eTable 3} in the \emph{Supplement} .

3.3 Outcomes

3.3.1 Operative time Four of the included studies evaluated the
operative time (total laryngectomy with/without neck dissection) of both
procedures\textsuperscript{11,12,14,15}. Two of these 4 studies included
only cases of isolated total laryngectomy (without neck
dissection)\textsuperscript{12,14}. The pooled results of 4 studies
showed that the operative time was lower in the SC group (MD, -63.2;
95\% confidence interval {[}CI{]}, -106.0 to -20.4), and a decrease in
operative time by 63.2 minutes was observed in the SC group
\textbf{(Figure 2a)}\textsuperscript{11,12,14,15}. Subgroup analysis
including the 2 studies without neck dissection also showed that the
operative time was lower in the SC group (MD, -45.9; 95\% CI, -64.2 to
-27.6) with a decrease of 45.9 minutes\textsuperscript{12,14}.
\textbf{(Figure 2b)}. 3.3.2 PCF All of the included studies recorded the
incidence of postoperative PCF in both groups. In the present study, the
incidence rates of PCF were 13.7\% (28/204) and 27.2\% (90/331) in the
SC and MC groups, respectively. The pooled analysis showed that the PCF
rate was lower in the SC group (OR = 0.38; 95\% CI, 0.18-0.83;~\emph{P}
= 0.016).\textbf{(Figure 3)}. 3.3.3 Length of hospital stay Three of the
included studies recorded the length of hospital stay in the two groups.
The pooled analysis demonstrated that the length of hospital stay after
TL was approximately 2.9 days shorter in the SC group than in the MC
group (MD, -2.9; 95\% CI, -5.6 to -0.1). (\textbf{Figure 4}). 3.3.4
Postoperative surgical site infection Two of the included studies
recorded the incidence of postoperative surgical site infection in both
groups. The pooled analysis showed no significant difference between the
SC and MC groups regarding the rate of postoperative surgical site
infection (OR = 0.41; 95\% CI, 0.02-8.73;~\emph{P} = 0.565).
(\textbf{Figure 5}).

3.4 Publication Bias

Funnel plots and the results of heterogeneity tests are presented
in\textbf{eFigure 1} in the\emph{Supplement} . The plots of different
parameters are generally symmetrical, suggesting no obvious publication
bias. The results of the Egger intercept test also indicated no apparent
publication bias.



\textbf{4 Discussion}

The present meta-analysis was conducted to evaluate the differences
between the SC and MC techniques after TL for laryngeal cancer in the
existing English literature. According to our meta-analysis, the SC
group demonstrated a significantly shorter operative time than the MC
group. In addition, we observed a lower incidence of PCF and hospital
stay after SC. The differences in postoperative surgical site infection
was not significant between groups with different closure techniques.

The pooled results from the analysis demonstrated that the operative
time for TL is approximately 45.9 to 63.2 minutes shorter with the SC
technique than with the MC technique. The result is intuitive because
the surgical stapler device is capable of dividing and closing
pharyngeal tissue simultaneously and instantly. In contrast, closure of
the pharyngeal defect by suturing after removal of the larynx is a
time-consuming step during TL. Ozturk et al reported that the closure
time needed for the pharyngeal mucosa was only 3.0 minutes with a
surgical stapler. However, it takes 37.5 minutes for surgeons to perform
a watertight closure of the pharynx by hand \textsuperscript{16}.
Several studies also indicated that prolonged surgical time was
significantly associated with a higher rate of postoperative
complications in patients undergoing TL \textsuperscript{17-19}.
Pharyngeal closure with a surgical stapler can therefore be a
time-saving technique for TL patients and potentially reduce the related
complications. One important step in the SC technique is to ensure that
the epiglottis is not trapped between the jaws of the surgical stapler.
There are different strategies to solve this problem. Some authors
retracted the epiglottis with an Allis clamp from the trachea lumen
below with or without an endoscopic field of
view\textsuperscript{10,11,13,15}. Some suggested that a small midline
pharyngotomy at the suprahyoid region enables the epiglottis to be
pulled anteriorly under direct vision without tapping it in the
pharyngeal mucosa \textsuperscript{14,20}.

TL is a life-saving procedure for individuals diagnosed with advanced
laryngeal cancer or those suffering from recurrence after organ
preservation treatment \textsuperscript{21}. However, permanent
tracheostomy, speech difficulty and altered swallowing may adversely
affect patients' physical and emotional health \textsuperscript{22}.
Among all the complications after TL, PCF is most commonly reported and
is related to a prolonged hospital stay as well as delayed adjuvant
therapy \textsuperscript{23}. In the present meta-analysis, the
incidence rates of PCF in the SC group and MC group were 13.7\% (28/204)
and 27.2\% (90/331), respectively. The incidence of PCF was
significantly lower in the SC group. Two possible explanations exist for
the reduced incidence of PCF in the SC group. First, six of the enrolled
studies used the closed technique\textsuperscript{10-13,15,16}, while
the remaining study used the semiclosed
technique\textsuperscript{14}when performing stapler closure of the
pharynx. None of the SC groups in each study used the open technique,
which involves the removal of the laryngeal specimen first and then the
closure of the free edges of the pharyngotomy with a stapler. By
avoiding the creation of a large pharyngeal defect before closure, the
risk of surgical field contamination by pharyngeal secretions can be
minimized with the use of a surgical stapler \textsuperscript{10,11,13}.
Second, blood supply to the surgical wound is believed to be fundamental
to the healing process after TL. However, repeated trauma by forceps and
focal ischemia from the tightening of sutures may both jeopardize the
microcirculation of the pharyngeal mucosa during MC
\textsuperscript{10,11}. On the other hand, the SC technique may be able
to preserve more blood supply with simultaneous stapling as well as
cutting of the pharynx, which may be beneficial to a better healing
process. Radiotherapy\textsuperscript{24-27} and
tracheostomy\textsuperscript{24,28} before TL have both been identified
as independent factors that are associated with a higher rate of PCF.
However, the pooled prevalence of patients receiving preoperative
tracheostomy and radiotherapy was significantly higher in the SC group.
The pooled results implied that the SC technique has the potential to
decrease the rate of PCF formation after TL even in irradiated or
tracheostomized patients.

The pooled results demonstrated that the length of hospital stay after
TL was approximately 2.9 days shorter in the SC group than in the MC
group and this probably reflected the different rate of postoperative
PCF between the two groups. Because of the lower PCF incidence with the
SC technique, more patients may be able to try oral feeding earlier and
reduce their length of hospital stay. Using a surgical stapler to close
pharyngeal defects during TL can prevent pharyngeal content from
contaminating the operative field. Theoretically, a reduced surgical
site infection rate is expected in the SC group. However, the results of
the present meta-analysis did not support this idea, and the rate of
surgical site infection was comparable between the SC and MC groups. One
possible reason may be that surgical site infection is a multifactorial
complication. Factors such as the general health status of the patient,
a lower serum albumin level, peri-operative blood transfusion and
operation time can all be associated with the rate of
infection\textsuperscript{29,30}.

This study had several limitations. First, only seven studies were
included in this meta-analysis. More studies are needed to confirm the
pooled results. Second, although some of the included articles were
randomized studies, retrospective studies were also included because of
the lack of available data in the current literature. Third, the
analysis of funnel plots and Egger's tests demonstrated no obvious
evidence of publication bias. However, the results of this meta-analysis
should be interpreted with caution because of the heterogeneity between
the included studies. Despite these limitations, our meta-analysis still
provides evidence for the use of different closure techniques in TL.



\textbf{5 Conclusion}

In conclusion, the SC technique significantly reduced the operative time
needed for TL. In addition, we also observed a lower incidence of PCF
and hospital stay after SC in all patients even though there were more
irradiated and tracheostomized patients in the SC group. We found
similar surgical site infection rates between the SC and MC groups. The
presented meta-analysis provides current evidence for the use of SC in
laryngeal cancer patients undergoing TL. The surgical stapler has the
potential to be a useful tool in the pharyngeal closure step during TL.

\textbf{Key points}

* Total laryngectomy is a life-saving procedure for individuals with
advanced laryngeal cancer or those suffering from recurrence after
initial treatment.

* Manual suturing of the pharyngeal mucosa after the removal of the
entire larynx, though time-consuming, is the technique traditionally
used for pharyngeal closure after total laryngectomy.

* The stapler closure technique significantly reduced the operative time
needed for total laryngectomy. In addition, we observed a lower
incidence of pharyngocutaneous fistula and hospital stay after stapler
closure in all patients. The rate of surgical site infection was
comparable between the stapler closure and manual closure groups.

* The presented meta-analysis provides current evidence for the use of
stapler closure in laryngeal cancer patients undergoing total
laryngectomy. The surgical stapler has the potential to be a useful tool
in the pharyngeal closure step during total laryngectomy.

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\textbf{Acknowledgments}

We thank Alfred Hsing-Fen Lin, MS, Raising Statistics Consultant Inc,
for his statistical assistance. He received compensation and declared no
competing interests between this study and his company.

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