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\begin{document}

\title{Comparison of endoscopic Vs microscopic ossiculoplasty; a study of 157
consecutive cases}



\author[1]{Holli Coleman}%
\author[2]{Theofano Tikka}%
\author[2]{John Curran }%
\author[2]{Arunachalam Iyer}%
\affil[1]{NHS Lanarkshire}%
\affil[2]{Monklands Hospital}%


\vspace{-1em}



  
  \date{May 16, 2024}


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\selectlanguage{english}
\begin{abstract}
1) Results of ossiculoplasty via trans-canal endoscopic (TEES) route is
comparable to that of the traditional microscopic approach 2) There was
no difference in complications or secondary outcomes such as tympanic
membrane residual perforation or ear discharge between these groups 3)
Both groups achieved an air-bone gap of less that 20dB in more than 70\%
of the cases 4) In our experience there was no difference in outcomes
based on ossiculoplasty material such as cartilage, titanium prosthesis
or autologous grafts such as incus. 5) Eroded stapes superstructure is
does not preclude getting improvements in ABG of less than 20dB, but
larger studies with longer follow ups might be useful.%
\end{abstract}%



\sloppy


\textbf{Key Words:} endoscopic, hearing loss, ossiculoplasty,
tympanomastoidectomy, tympanoplasty

Level of evidence: 3

\textbf{Introduction}

Trans-canal endoscopic ear surgery (TEES) carries the benefits of
enhanced visualization shorter operating times and no external incision.
However, TEES does have the disadvantage of being a one-handed procedure
and bleeding can jeopardize the visual field\textsuperscript{\textbf{1}}
. Current literature suggests TEES provides similar audiometric,
functional, and safety outcomes to those of microsurgery in
tympanoplasty, cholesteatoma surgery and
stapedectomy~\textsuperscript{\textbf{2,3}} . There are very few
published studies on outcomes of TEES in ossiculoplasty. Our study aimed
to compare audiometric outcomes of patients undergoing ossiculoplasty
employing either the TEES or microsurgery approach performed by a single
otologist.

\textbf{Methods}

\textbf{2.1 Study Design}

Retrospective analysis of data from a prospective audit of
ossiculoplasty. STROBE guidelines were used to present the findings.

\textbf{2.2 Setting}

Patients underwent surgery in a secondary care hospital between
2009-2018

\textbf{2.3 Participants}

157 consecutive patients who underwent ossiculoplasty were included.
Those without 3 months postoperative audiogram were excluded. Cases,
where the endoscope was the only instrument used, were classed as TEES,
and others were as microsurgery.

\textbf{2.4 Variables}

Apart from the surgical approach, other variables analysed included the
condition of the ossicles, type and the material used for ossiculoplasty
and tympanic membrane graft.

\textbf{2.5 Ethical considerations}

The study is registered as an audit and further ethics committee
approval was not required.

\textbf{2.6 Surgical details}

Operations were carried out using either a Zeiss microscope or a
0-degree, 3 mm, 14 cm Storz endoscope in the TEES or combined group. The
disease was characterized at tympanotomy including perforations,
condition of ossicles, and the site and extent of cholesteatoma before
completion of ossiculoplasty.

\textbf{2.7 Audiology outcomes}

Audiometric outcomes including air conduction (AC), bone conduction
(BC), and air-bone gap (ABG) were recorded at 3- and 12- months
postoperatively and compared to pre-operative levels. The average of
500, 1000, 2000, and 3000 Hz was used for analysis. as per AAOHNS
recommendations.

\textbf{2.8 Outcome measures}

The primary outcome was postoperative ABG. Secondary outcomes included
changes in AC, BC, and ABG of less than 20 dB.

\textbf{2.9 Statistical analysis}

The data was compiled using the Common Otology Audit database and
analysed using SPSS 27. Data are summarised as means +/- standard
deviation (SD) for numerical values and count and percentages for
categorical variables. The student t-test was used for continuous data
and categorical variables were compared using the chi-square and
Fischer's exact test as appropriate. A p-value of \textless{}0.05 was
considered statistically significant.

\textbf{3.} \textbf{Results}

\textbf{3.1 Patient Population and Demographic Data}

The mean age was 36 years (range: 7-82) and 71 (56\%) patients were
male. Fifty patients (31.8\%) underwent TEES whereas 107 (68.2\%)
underwent microsurgery (80) or a combined endoscopic approach (27).

The mean (SD in brackets) pre-operative hearing for the whole group,
microscopic group, and TEES group were as follows. AC 43.4dB (17.7),
42.7dB (18.1), 44.8dB (16.8). BC 20.3dB (12.3), 19.8dB (12.7), and
21.2dB (11.4) and the ABG 21.8dB (11.8), 21dB (12.3) 23.6dB (10.4),
respectively. There was no significant difference between groups (p
\textgreater{}0.05).

\textbf{3.2 Disease characteristics~}

Nineteen (12.1\%) of the whole cohort were noted to have stapes erosion,
11 of these patients were dealt with TEES (22\% of the TEES) compared to
only 8 (7.5\%) in the microscopic group (P\textless{}0.001). Other
disease characteristics such as tympanic membrane perforation, condition
of ossicles, site, and extent of cholesteatoma are shown in Table 1.

\textbf{3.3 Ossiculoplasty type}

Cartilage ossiculoplasty was the commonest approach, with a cartilage
disc applied directly to stapes head touching the tympanic membrane in
71 (45.5\%) patients, 47 (44.8\%) within the microscopic group and 24
(48\%) of the TEES group, their proportion did not differ significantly
(P \textgreater{}0.05). The other materials used were incus in 42 ears
(27.1\%), Titanium PORP / TORP (Grace medical, USA) in 34 (21.9\%),
malleus head, bone cement and bone chip in very small cases (Table 2)
Tympanic membrane to stapes ossiculoplasty was the commonest type of
procedure employed, in 128 (82.1\%) of the whole cohort, 93 of those
were approached microscopically and 35 via TEES. The other
ossiculoplasty types were tympanic membrane to footplate with TORP and
footplate shoe in 11 (7.1\%) and incus to stapes in 14 (9\%). There was
no significant difference in the proportion with each type of
reconstruction (Table 2)

\textbf{3.4 Tympanoplasty materials}

Significantly more patients within the microsurgery group had temporalis
fascia graft compared to the TEES group, 92 (86\%) Vs 1 (2\%),
p\textless{}0.001, perichondrium and cartilage was the preferred graft
within the TEES group, 33 (66\%) v 2 (1.9\%), p\textless{}0.001. Details
of intra-operative characteristics can be found in Table 2.

\textbf{3.5 Hearing outcomes}

There were significant improvements at 3-month follow-up in AC, 43.4dB
(17.7) Vs 36.2dB (17.4), p\textless{}0.001, BC, 20.3dB (12.3) Vs 17.6dB
(12.6), p\textless{}0.001, and ABG 21.8dB, (11.8) Vs 16.7dB (10.4),
p\textless{}0.001, compared to pre-operative hearing.

In the microsurgery group, there were statistically significant
improvements in AC, 42.7dB (17.7) Vs 36dB (17.2), p\textless{}0.001)),
BC, 19.8dB (12.3) Vs 16.7dB (12.4), p\textless{}0.001 and ABG (21dB
(11.8) Vs 16.9dB (10.4), p\textless{}0.001. In the TEES group there were
statistically significant improvements in AC, 44.8dB (16.8) Vs 36.8dB
(17.8), p\textless{}0.001, BC 21.2dB (11.4) Vs 19.5dB (12.9),
p\textless{}0.001, and ABG 23.6dB (10.4) Vs 16dB (10.40),
p\textless{}0.001.

When compared to the microscopic approach, there was no statistically
significant difference in improvement in AC, 6.7dB (19.2) Vs 8.0dB
(14.9), p=0.665, BC, 3.1dB (10.4) Vs 1.7dB (6.6), p=0.632 and ABG 4.0dB
(14.8) Vs 7.5dB (13.6), p=0.160 in those who underwent TEES.

73\% of those in the microscopic group and 72\% in the TEES group
achieved an ABG better than 20dB with no significant difference (p
=0.907).~All variables including the use of different TM grafts and
ossiculoplasty materials made no significant difference to the AC, BC
and ABG (all comparisons p\textgreater{}0.05) across the whole cohort
and when hearing outcomes of the microscopic and TEES groups were
compared (see Table 3)

Nineteen of 157 patients were noted to have stapes dehiscence at the
time of operation. Both microscopic and TEES sub-groups achieved
improvements in AC, 6.2dB (16.8) Vs 7.2dB (18.1), p= 0.8, BC 1.6dB (5.4)
Vs 2.8dB (9.8), p= 0.62 and ABG, 4.6dB (15) Vs 5.2dB (14.4) and the
difference was not statistically significant (p= 0.85). This remained
true when comparing those approached microscopically and via TEES
(p\textgreater{}0.05) (see Table 4)

Of 79 patients (59 microscopic and 20 TEES) who were reviewed 12 months
post-ossiculoplasty, there were no significant changes in AC, BC, or ABG
when compared to 3 months (p\textgreater{} 0.05). (Table 3)

\textbf{3.6 Secondary outcomes~}

At 3-month follow-up, 3.7\% and 4\% had residual perforations (p=0.623)
and ear discharge was observed in 5.6\% and 2\% (P=0.286) of the
microscopic and TEES groups, respectively. There was a higher incidence
of myringitis in 38\% of the TEES group when compared to 22.4\% in the
microsurgery group (p= 0.042). Only one patient was noted to have
residual cholesteatoma and they were part of the microscopic group
(p=0.682). There were no statistically significant differences in
postoperative complications between both groups at 12 months. (Table 3).

\textbf{Discussion}

To our knowledge, our study is the biggest series comparing
ossiculoplasty by microscopic route to that of TEES performed by a
single surgeon and has demonstrated that it produces comparable hearing
outcomes in AC, BC and ABG less than 20dB

There was no significant difference in the improvement in AC, BC, and
ABG of the 93 patients undergoing TM-stapes reconstruction via the
microscopic approach compared to 35 patients in the TEES group. Our
study also showed that there was also no significant difference with
various tympanic membrane grafts and ossiculoplasty materials including
just using cartilage as opposed to the use of titanium PORP and incus
transposition. These results were comparable to those obtained by
Potsangbam et \textsuperscript{\textbf{4}} ~al in their cases with
cartilage ossiculoplasty with intact stapes superstructure.

Only 19 patients were noted to have stapes dehiscence at the time of
operation. Despite this, all patients achieved improvement in AC, BC,
and ABG. There was no statistical difference in hearing improvement
between those 19 patients with dehiscence compared to those 138 without,
approached either microscopically or via TEES.

There are some studies in the literature \textsuperscript{\textbf{5-9}}
, including an RCT of 118 cases comparing TEES and microsurgery using
PORP and TORP showing similar results between microsurgery and TEES. But
unlike our series, they were not by a single surgeon and haven't
included cartilage and incus grafts.

Our study has certain limitations. The patients who were operated on
before 2014 all had a microscopic approach before the surgeon started
TEES. In addition, there was no randomization of patients to groups,
therefore the potential for selection bias exists. But the advantages to
our study are prospective data collection and all surgeries being
conducted by a single surgeon, thus eliminating some of the bias.

\textbf{Conclusion}

We demonstrated improvement in audiometric outcomes regardless of
surgical approach, stapes condition, type of ossiculoplasty, or TM
reconstruction material used. TEES is therefore safe and as effective as
microsurgery in ossiculoplasty and has the advantages of less
pain\textsuperscript{\textbf{10}} and morbidity. Larger sample size and
a longer follow-up period may show significant discrimination between
surgical approaches and materials used.

\textbf{Key Points}

\begin{enumerate}
\tightlist
\item
  \textbf{Results of ossiculoplasty via trans-canal endoscopic (TEES)
  route is comparable to that of the traditional microscopic approach}
\item
  \textbf{There was no difference in complications or secondary outcomes
  such as tympanic membrane residual perforation or ear discharge
  between these groups}
\item
  \textbf{Both groups achieved an air-bone gap of less than 20dB in more
  than 70\% of the cases}
\item
  \textbf{In our experience there was no difference in outcomes based on
  ossiculoplasty material such as cartilage, titanium prosthesis or
  autologous grafts such as incus.}
\item
  \textbf{Eroded stapes superstructure does not preclude getting
  improvements in ABG of less than 20dB, but larger studies with longer
  follow-ups might be useful.}
\end{enumerate}

\textbf{References}

\begin{enumerate}
\item
  Kobayashi T, Gyo K, Komori M, Hyodo M. Efficacy and Safety of
  Transcanal Endoscopic Ear Surgery for Congenital Cholesteatomas: A
  Preliminary Report. Otol Neurotol. 2015 Dec;36(10):1644-50. doi:
  10.1097/MAO.0000000000000857. PMID: 26485586.
\item
  Li B, Zhou L, Wang M, Wang Y, Zou J. Endoscopic versus microscopic
  surgery for treatment of middle ear cholesteatoma: A systematic review
  and meta-analysis. Am J Otolaryngol. 2021 Mar-Apr;42(2):102451. doi:
  10.1016/j.amjoto.2020.102451. Epub 2020 Mar 5. PMID: 33360773.
\item
  Hoskison EE, Harrop E, Jufas N, Kong JHK, Patel NP, Saxby AJ.
  Endoscopic Stapedotomy: A Systematic Review. Otol Neurotol. 2021 Dec
  1;42(10):e1638-e1643. doi: 10.1097/MAO.0000000000003242. PMID:
  34267093.
\item
  Potsangbam DS, Akoijam BA. Endoscopic Transcanal Autologous Cartilage
  Ossiculoplasty. Indian J Otolaryngol Head Neck Surg. 2019
  Mar;71(1):54-59. doi: 10.1007/s12070-018-1518-x. Epub 2018 Oct 30.
  PMID: 30906714; PMCID: PMC6401045.
\item
  Caloway CL, Basonbul RA, Ronner EA, Tolisano AM, Zhu AW, Suresh H, Lee
  DJ, Isaacson B, Cohen MS. Pediatric Endoscopic Ossiculoplasty
  Following Surgery for Chronic Ear Disease. Laryngoscope. 2020
  Dec;130(12):2896-2899. doi: 10.1002/lary.28526. Epub 2020 Feb 5. PMID:
  32022283.
\item
  Das A, Mitra S, Ghosh D, Sengupta A. Endoscopic ossiculoplasty: Is
  there any edge over the microscopic technique? Laryngoscope. 2020
  Mar;130(3):797-802. doi: 10.1002/lary.28074. Epub 2019 May 23. PMID:
  32073145.
\item
  Yawn RJ, Hunter JB, O'Connell BP, Wanna GB, Killeen DE, Wick CC,
  Isaacson B, Rivas A. Audiometric Outcomes Following Endoscopic
  Ossicular Chain Reconstruction. Otol Neurotol. 2017
  Oct;38(9):1296-1300. doi: 10.1097/MAO.0000000000001527. PMID:
  28796085.
\item
  Tsetsos N, Vlachtsis K, Stavrakas M, Fyrmpas G. Endoscopic versus
  microscopic ossiculoplasty in chronic otitis media: a systematic
  review of the literature. Eur Arch Otorhinolaryngol. 2021
  Apr;278(4):917-923. doi: 10.1007/s00405-020-06182-6. Epub 2020 Jul 7.
  PMID: 32632614.
\item
  Chung J, Kang JY, Kim MS, Kim B, Choi JW. Microscopic vs Endoscopic
  Ear Surgery for Congenital Ossicular Anomaly. Otolaryngol Head Neck
  Surg. 2020 Apr;162(4):548-553. doi: 10.1177/0194599819900489. Epub
  2020 Jan 21. PMID: 31959042.
\item
  McCallum R, Mohd Slim MA, Iyer A. An audit of post-operative pain
  scores after endoscopic and microscopic ear surgery. Clin Otolaryngol.
  2021 Dec 20. doi: 10.1111/coa.13904. Epub ahead of print. PMID:
  34931457.
\item
\end{enumerate}

\textbf{Table 1}. This table shows the operative findings and
pre-operative audiological results in both TEES and microsurgery groups.
There was no difference in pre-operative hearing levels between groups,
cholesteatoma was more extensive in the microscopic group.\textbf{Table
2}. This shows the types of ossiculoplasty reconstruction, materials
used in ossiculoplasty and the tympanic membrane graft. Cartilage was
the commonest material used followed by incus and titanium PORP / TORP
and there was no difference between groups. There was a significant
difference in the tympanic membrane graft material, with more cases in
the microscopic group using temporalis facia
(p\textless{}0.001)\textbf{Table 3.} This shows the outcomes at 3 and12
months following surgery. There was no significant difference in hearing
or other outcomes apart from a higher incidence of myringitis in the
TEES group at 3 months (p=0.042). At 12 months following surgery, there
was a significantly lower AC level in the TEES group (p=0.033). All the
other outcomes did not show any significant difference.\textbf{Table 4.}
This shows the mean differences of AC, BC and ABG between those with and
without erosion of stapes superstructure. There was no statistically
significant difference between groups.

\textbf{Hosted file}

\verb`Ossic Table 1.docx`  available at \url{https://authorea.com/users/456980/articles/553867-comparison-of-endoscopic-vs-microscopic-ossiculoplasty-a-study-of-157-consecutive-cases}

\textbf{Hosted file}

\verb`Ossic Table 2.docx`  available at \url{https://authorea.com/users/456980/articles/553867-comparison-of-endoscopic-vs-microscopic-ossiculoplasty-a-study-of-157-consecutive-cases}

\textbf{Hosted file}

\verb`Ossic Table 3.docx`  available at \url{https://authorea.com/users/456980/articles/553867-comparison-of-endoscopic-vs-microscopic-ossiculoplasty-a-study-of-157-consecutive-cases}

\textbf{Hosted file}

\verb`Ossic Table 4.docx`  available at \url{https://authorea.com/users/456980/articles/553867-comparison-of-endoscopic-vs-microscopic-ossiculoplasty-a-study-of-157-consecutive-cases}

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