Robotic endoscopic surgery in a porcine model of the infant neck
Identifieur interne : 002424 ( Pmc/Checkpoint ); précédent : 002423; suivant : 002425Robotic endoscopic surgery in a porcine model of the infant neck
Auteurs : Russell A. Faust [États-Unis] ; Adrien J. Kant [États-Unis] ; Attila Lorincz [États-Unis] ; Abbas Younes [États-Unis] ; Elizabeth Dawe [États-Unis] ; Michael D. Klein [États-Unis]Source :
- Journal of Robotic Surgery [ 1863-2483 ] ; 2007.
Abstract
Minimally invasive surgery is rapidly becoming the desired surgical standard, especially for pediatric patients. Infants and children are a particular technical challenge, however, because of the small size of target anatomical structures and the small surgical workspace. Computer-assisted robot-enhanced surgical telemanipulators may overcome these challenges by facilitating surgery in a small workspace. We studied the feasibility of performing robotic endoscopic neck surgery on a porcine model of the human infant neck. The study design was a prospective, feasibility pilot study of a small cohort for proof of concept and for a survival model. Sixteen non-survival piglets weighing 4.5–10 kg were used to develop the surgical approach and operative technique. Eight piglets aged 3–6 weeks old and weighing 4.0–9.1 kg underwent survival thyroidectomy by a cervical endoscopic approach using the Zeus surgical robot, which includes the Aesop endoscope holder and “Microwrist” microdissecting instruments. We succeeded in performing endoscopic robotic neck surgery on a piglet as small as 4 kg, in an operative pocket as small as 2 cm3. Total incision length for all three ports was ≤23 mm. There were no major complications, no major robotic instrument malfunctions or breakages, and no procedures required conversion to open surgery. These results support the feasibility of robotic endoscopic neck surgery on a neck the size of a human infant’s.
The online version of this article (doi: 10.1007/s11701-006-0007-5) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1007/s11701-006-0007-5
PubMed: NONE
PubMed Central: 4677346
Affiliations:
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neck</title><author><name sortKey="Faust, Russell A" sort="Faust, Russell A" uniqKey="Faust R" first="Russell A." last="Faust">Russell A. Faust</name><affiliation wicri:level="2"><nlm:aff id="Aff1">Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit, MI 48201 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Michigan</region></placeName><wicri:cityArea>Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit</wicri:cityArea></affiliation></author><author><name sortKey="Kant, Adrien J" sort="Kant, Adrien J" uniqKey="Kant A" first="Adrien J." last="Kant">Adrien J. Kant</name><affiliation wicri:level="2"><nlm:aff id="Aff1">Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit, MI 48201 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Michigan</region></placeName><wicri:cityArea>Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit</wicri:cityArea></affiliation></author><author><name sortKey="Lorincz, Attila" sort="Lorincz, Attila" uniqKey="Lorincz A" first="Attila" last="Lorincz">Attila Lorincz</name><affiliation wicri:level="2"><nlm:aff id="Aff1">Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit, MI 48201 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Michigan</region></placeName><wicri:cityArea>Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit</wicri:cityArea></affiliation></author><author><name sortKey="Younes, Abbas" sort="Younes, Abbas" uniqKey="Younes A" first="Abbas" last="Younes">Abbas Younes</name><affiliation wicri:level="2"><nlm:aff id="Aff1">Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit, MI 48201 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Michigan</region></placeName><wicri:cityArea>Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit</wicri:cityArea></affiliation></author><author><name sortKey="Dawe, Elizabeth" sort="Dawe, Elizabeth" uniqKey="Dawe E" first="Elizabeth" last="Dawe">Elizabeth Dawe</name><affiliation wicri:level="2"><nlm:aff id="Aff1">Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit, MI 48201 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Michigan</region></placeName><wicri:cityArea>Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit</wicri:cityArea></affiliation></author><author><name sortKey="Klein, Michael D" sort="Klein, Michael D" uniqKey="Klein M" first="Michael D." last="Klein">Michael D. Klein</name><affiliation wicri:level="2"><nlm:aff id="Aff1">Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit, MI 48201 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Michigan</region></placeName><wicri:cityArea>Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit</wicri:cityArea></affiliation></author></analytic><series><title level="j">Journal of Robotic Surgery</title><idno type="ISSN">1863-2483</idno><idno type="eISSN">1863-2491</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Minimally invasive surgery is rapidly becoming the desired surgical standard,
especially for pediatric patients. Infants and children are a particular technical
challenge, however, because of the small size of target anatomical structures and
the small surgical workspace. Computer-assisted robot-enhanced surgical
telemanipulators may overcome these challenges by facilitating surgery in a small
workspace. We studied the feasibility of performing robotic endoscopic neck surgery
on a porcine model of the human infant neck. The study design was a prospective,
feasibility pilot study of a small cohort for proof of concept and for a survival
model. Sixteen non-survival piglets weighing 4.5–10 kg were used to develop the
surgical approach and operative technique. Eight piglets aged 3–6 weeks old and
weighing 4.0–9.1 kg underwent survival thyroidectomy by a cervical endoscopic
approach using the Zeus surgical robot, which includes the Aesop endoscope holder
and “Microwrist” microdissecting instruments. We succeeded in performing endoscopic
robotic neck surgery on a piglet as small as 4 kg, in an operative pocket as small
as 2 cm<sup>3</sup>. Total incision length for all three ports was
≤23 mm. There were no major complications, no major robotic instrument malfunctions
or breakages, and no procedures required conversion to open surgery. These results
support the feasibility of robotic endoscopic neck surgery on a neck the size of a
human infant’s.</p><sec><title>Electronic supplementary material</title><p>The online version of this article (doi: 10.1007/s11701-006-0007-5) contains supplementary material, which is available to authorized
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Ng" uniqKey="Hockstein N">NG Hockstein</name></author></analytic></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Robot Surg</journal-id><journal-id journal-id-type="iso-abbrev">J Robot Surg</journal-id><journal-title-group><journal-title>Journal of Robotic Surgery</journal-title></journal-title-group><issn pub-type="ppub">1863-2483</issn><issn pub-type="epub">1863-2491</issn><publisher><publisher-name>Springer-Verlag</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmc">4677346</article-id><article-id pub-id-type="publisher-id">7</article-id><article-id pub-id-type="doi">10.1007/s11701-006-0007-5</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>Robotic endoscopic surgery in a porcine model of the infant
neck</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Faust</surname><given-names>Russell A.</given-names></name><address><phone>+1-313-7455402</phone><fax>+1-313-7455402</fax><email>faustr@chi.osu.edu</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Kant</surname><given-names>Adrien J.</given-names></name><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Lorincz</surname><given-names>Attila</given-names></name><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Younes</surname><given-names>Abbas</given-names></name><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Dawe</surname><given-names>Elizabeth</given-names></name><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Klein</surname><given-names>Michael D.</given-names></name><xref ref-type="aff" rid="Aff1"></xref></contrib><aff id="Aff1">Children’s Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Street, Detroit, MI 48201 USA</aff></contrib-group><pub-date pub-type="epub"><day>30</day><month>1</month><year>2007</year></pub-date><pub-date pub-type="pmc-release"><day>30</day><month>1</month><year>2007</year></pub-date><pub-date pub-type="ppub"><year>2007</year></pub-date><volume>1</volume><fpage>75</fpage><lpage>83</lpage><history><date date-type="accepted"><day>28</day><month>11</month><year>2006</year></date></history><permissions><copyright-statement>© Springer London 2007</copyright-statement></permissions><abstract id="Abs1"><p>Minimally invasive surgery is rapidly becoming the desired surgical standard,
especially for pediatric patients. Infants and children are a particular technical
challenge, however, because of the small size of target anatomical structures and
the small surgical workspace. Computer-assisted robot-enhanced surgical
telemanipulators may overcome these challenges by facilitating surgery in a small
workspace. We studied the feasibility of performing robotic endoscopic neck surgery
on a porcine model of the human infant neck. The study design was a prospective,
feasibility pilot study of a small cohort for proof of concept and for a survival
model. Sixteen non-survival piglets weighing 4.5–10 kg were used to develop the
surgical approach and operative technique. Eight piglets aged 3–6 weeks old and
weighing 4.0–9.1 kg underwent survival thyroidectomy by a cervical endoscopic
approach using the Zeus surgical robot, which includes the Aesop endoscope holder
and “Microwrist” microdissecting instruments. We succeeded in performing endoscopic
robotic neck surgery on a piglet as small as 4 kg, in an operative pocket as small
as 2 cm<sup>3</sup>. Total incision length for all three ports was
≤23 mm. There were no major complications, no major robotic instrument malfunctions
or breakages, and no procedures required conversion to open surgery. These results
support the feasibility of robotic endoscopic neck surgery on a neck the size of a
human infant’s.</p><sec><title>Electronic supplementary material</title><p>The online version of this article (doi: 10.1007/s11701-006-0007-5) contains supplementary material, which is available to authorized
users.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Endoscopy/endoscopic</kwd><kwd>Infant</kwd><kwd>Neck dissection</kwd><kwd>Pediatric</kwd><kwd>Robot</kwd><kwd>Robotic surgery</kwd><kwd>Thyroidectomy</kwd><kwd>Aesop</kwd><kwd>Hermes</kwd><kwd>Zeus</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© Springer London 2007</meta-value></custom-meta></custom-meta-group></article-meta></front><body><sec id="Sec1" sec-type="introduction"><title>Introduction</title><p>As minimally invasive surgery emerges as the desired standard, endoscopic
methods have developed to meet this objective. In some surgical disciplines, and for
some surgical procedures, endoscopic methods are the preferred technique, for
example in laparoscopy and thoracoscopy [<xref ref-type="bibr" rid="CR1">1</xref>–<xref ref-type="bibr" rid="CR5">5</xref>]. Endoscopic
applications in the field of otolaryngology (head and neck surgery) have made
significant advances in endoscopic sinus surgery and in endoscopic craniofacial
surgery for both traumatic and cosmetic reconstruction [<xref ref-type="bibr" rid="CR6">6</xref>–<xref ref-type="bibr" rid="CR8">8</xref>].
More recently, pioneers of endoscopic surgery have begun to adapt techniques that
were originally developed for body cavities (e.g. laparoscopy and pelviscopy) to
operate in the axillae and other anatomic regions where cavities are not found
[<xref ref-type="bibr" rid="CR9">9</xref>–<xref ref-type="bibr" rid="CR12">12</xref>]. In the past ten years innovative surgeons have begun to test
the limits of endoscopic techniques for parathyroidectomy and thyroidectomy in
humans [<xref ref-type="bibr" rid="CR13">13</xref>–<xref ref-type="bibr" rid="CR18">18</xref>]. Others have begun to model more extensive
endoscopic neck procedures in animal models [<xref ref-type="bibr" rid="CR19">19</xref>–<xref ref-type="bibr" rid="CR22">22</xref>]. The transition
to endoscopic surgery challenges the surgeon with fewer degrees of freedom, less
tactile (“haptic”) feedback, amplification of small movements into large translated
movements because of the length of endoscopic instruments, and body postures for the
surgeon that are often ergonomically unsatisfactory. All of these challenges are
amplified with the pediatric patient. The advent of computer-assisted surgical
robots improves on most of these challenges. Pediatric surgeons have been
particularly interested in endoscopic and robot-enhanced surgery, because pediatric
surgeons apply minimally invasive techniques to a broader range of procedures than
do adult surgeons. The objectives of minimally invasive techniques, including
minimizing postoperative pain and optimizing cosmesis, are paramount in the
pediatric patient. Thus, pediatric surgeons are extending these techniques to
infant, newborn, and even fetal procedures [<xref ref-type="bibr" rid="CR23">23</xref>–<xref ref-type="bibr" rid="CR30">30</xref>]. Endoscopic
surgery on the infant patient is, however, characterized by particular challenges in
addition to those present in the adult analog:</p><p><list list-type="bullet"><list-item><p>body cavities are smaller, with the result that the effects of tremor and
imprecision are magnified;</p></list-item><list-item><p>endoscopic “exposure,” or visibility, is reduced;</p></list-item><list-item><p>organs and tissues are smaller and more delicate, and thus more
susceptible to injury; and, finally</p></list-item><list-item><p>the closer confines of the anatomy necessitate close proximity of camera
and instruments, with increased potential for collision.</p></list-item></list></p><p>As a result, although minimally invasive endoscopic or robotic surgery may have
benefits that are most desired in the pediatric patient population, it is precisely
this population that poses the greatest challenge to applying these techniques
[<xref ref-type="bibr" rid="CR27">27</xref>]. Inspired by pioneering work in
endoscopic neck surgery [<xref ref-type="bibr" rid="CR21">21</xref>,
<xref ref-type="bibr" rid="CR22">22</xref>, <xref ref-type="bibr" rid="CR31">31</xref>, <xref ref-type="bibr" rid="CR32">32</xref>], and by
robotic endoscopic surgery in ever-smaller spaces [<xref ref-type="bibr" rid="CR28">28</xref>, <xref ref-type="bibr" rid="CR30">30</xref>, <xref ref-type="bibr" rid="CR33">33</xref>], we sought to determine whether robotic
surgery could be successfully performed on a survival animal model with a neck the
size of a human infant. Previous reports of endoscopic neck surgery that have used a
porcine model of the adult neck have employed pigs ranging in size from 20 to 60 kg
[<xref ref-type="bibr" rid="CR21">21</xref>, <xref ref-type="bibr" rid="CR22">22</xref>, <xref ref-type="bibr" rid="CR34">34</xref>, <xref ref-type="bibr" rid="CR35">35</xref>]. In addition to the challenges described
above, further limitations to performing robotic endoscopic surgery on smaller
models have included the size limits, the types of instrument currently available,
and lack of optimum animal models for neck surgery. On the basis of recent reports
of successful endoscopic neck procedures on the porcine model we decided to
determine the feasibility of performing robotic endoscopic neck surgery on much
smaller pigs. Our experience developing a technique for thyroidectomy as a test
procedure for “proof of concept” on piglets ranging in size from 4 to 9 kg is
reviewed below.</p></sec><sec id="Sec2"><title>Methods</title><p>Animals were cared for humanely according to Institutional Animal Care and Use
Committee Guidelines at Wayne State University School of Medicine. The committee
approved all procedures, and animals were under the constant care of a veterinarian.
A total of 24 live animal dissections were performed.</p><sec id="Sec3"><title>Non-survival phase I</title><p>Sixteen live, non-survival piglets weighing between 4.5 and 10 kg were
operated on to gain familiarity with porcine neck anatomy, and to conceptualize
and develop the robotic endoscopic technique, including refinement of robot arms
and camera placement, trocars placement, balloon and blunt dissection technique,
and insufflation technique in the neck. Most non-survival animals underwent other
surgical procedures either before or after robotic endoscopic neck surgery,
primarily intra-abdominal robotic endoscopic procedures. Open neck dissection was
undertaken to examine anatomic planes and port positions only when surgery could
not be completed using the surgical robot. Notes on operative times were kept
during the latter half of Phase I development.</p></sec><sec id="Sec4"><title>Survival phase II</title><p>Eight survival animals, weighing between 4.0 and 9.1 kg underwent robotic
endoscopic thyroidectomy. Survival animals underwent neck surgery only. A surgical
log was kept, and procedures were photographed and recorded, for qualitative and
quantitative recording of the experience.</p></sec><sec id="Sec5"><title>Surgical procedure</title><p>Animals were fasted for 16 h before surgery, although water was provided.
Anesthesia was induced with ketamine (22 mg kg<sup>−1</sup> IM)
and acepromazine (1.1 mg kg<sup>−1</sup> IM), and buprenorphine
(0.01 mg kg<sup>−1</sup> IM) for preemptive analgesia. The
animals were intubated and isoflurane (2–3%) was administered for general
anesthesia. Respiration was supported with a mechanical ventilator. After first
optimizing procedures and techniques during Phase I, procedures on infant piglets
were performed in a sterile operating room environment (Phase II). After induction
of anesthesia the neck was shaved and prepared and draped in a sterile manner,
with the piglet in the supine position. The Zeus Surgical Robot (Computer Motion,
CMI, Goleta, CA, USA) with two instrument arms and the Aesop video arm (controlled
by means of the Hermes voice-actuated interface from Computer Motion) were used.
The robotic system was set up before skin preparation and then draped into the
sterile field with the animal. It consists of several units (Fig. <xref rid="Fig1" ref-type="fig">1</xref>): the robotics unit, with surgeon hand controls, is
positioned behind the seated surgeon. The system provides the surgeon with voice
control of the Aesop camera arm and voice control of most of the electronic
devices in the OR, through a headset microphone. A high-definition monitor is
placed low in front of the surgeon, providing the surgeon with a view of the
operating table, patient, robot, and surgical assistant. The three robotic arms
are mounted separately on the OR table rails. Although many instruments were
experimented with during development of techniques in Phase I, we decided to use
the smallest smooth-jawed grasping instruments available at that time, in both
robot arms, for dissection of tissue of survival animals. These were the Zeus
micro-needle holders, with a jaw width of 1 mm and a “hand” length of 7 mm
(Fig. <xref rid="Fig2" ref-type="fig">2</xref>), For Phase II survival piglets,
three ports (Ethicon, Cincinnati, OH, USA) were used (Fig. <xref rid="Fig3" ref-type="fig">3</xref>). An 11-mm transverse cervical incision was created
in the midline between the mandibular angles, the platysma was divided sharply,
and an 11-mm non-bladed trocar was introduced into the subplatysmal plane toward
the sternal notch in the midline. Dissection in the sub-platysmal plane was
performed either bluntly, using the spreading technique with “Kelly” forceps, or
by insertion of a 1,000 cm<sup>3</sup> “pre-peritoneal dissection
(hernia) balloon” (AutoSuture OMS-PDB 1,000; US Surgical, Norwalk, CT, USA), with
an attempt made to inflate the balloon to approximately
300 cm<sup>3</sup>. In extremely small animals the balloon could
not be inflated and merely provided a means of blunt dissection. This dissection
facilitated instrument port placement and developed the central operative pocket,
which remained a potential space until insufflated. After dissection an 11 mm
trocar was reinserted through the incision and was used as the port for the 0°
10 mm endoscope and camera during the procedure, held and controlled by Aesop. The
same port was used for retrieval of the resected thyroid specimen at the end of
the procedure. Insufflation with CO<sub>2</sub> was initiated, and the
flow was varied spontaneously to maintain a constant pocket pressure of 4 mmHg.
This inflated the operative pocket to several square centimeters, as measured by
direct comparison with the instruments. During the procedure the animal’s body
temperature, heart rate, electrocardiogram, and oxygen saturation were monitored.
Two 5-mm trocars were inserted laterally under endoscopic visualization, entering
just inferior to the mandibular angle on either side through stab-incisions with a
no. 11 blade (Fig. <xref rid="Fig3" ref-type="fig">3</xref>). These operative
ports introduced Zeus instruments (Figs. <xref rid="Fig2" ref-type="fig">2</xref>, <xref rid="Fig3" ref-type="fig">3</xref>) to the operative
pocket. After dissection and isolation of the thyroid gland, one of the 5 mm
instruments was removed; a 0° 5 mm endoscope was inserted through its port, and
the specimen was retrieved through the 11 mm trocar using a simple endoscopic
grasper under endoscopic visualization. After removal of the thyroid specimen the
10 mm endoscope was returned to Aesop and used to visually inspect the operative
cavity for injuries or hemorrhage. Insufflation was stopped, instruments were
removed, and incisions sutured. Postoperative diet was ad lib. The Phase II
survival piglets were killed one week postoperation. Postoperative medication
included an analgesic, buprenorphine (0.05 mg kg<sup>−1</sup> IM
prn), and topical antibiotic ointment applied to the surgical incisions for two
days postoperatively. Thyroid was confirmed histologically; post-mortem
dissections were performed to inspect for evidence of nerve or vessel injury. Data
collected included pre and postoperative weight and operative times. Anesthesia
time was measured from induction to incision closure. Robotic setup time included
the entire sterile prep, draping of the pig and robot, readying the arms and
moving them into position. Port placement included the initial balloon dissection
and insertion of both instrument ports when the camera was in place. Operating
time referred to the period of robotic surgery from when instruments were
introduced until the thyroid was dissected free. Extraction time and time to close
incisions were also recorded. <fig id="Fig1"><label>Fig. 1</label><caption><p>Zeus surgical robot.<bold> a</bold> Zeus
surgical telemanipulator system. Surgeon sits at control console at right,
with control unit behind, and three monitors in front. The large monitor
furnishes a high-resolution two-dimensional endoscopic view of the
surgical workspace; the next monitor to the right shows Hermes
voice-commands for the Aesop camera holder; the third monitor shows
motion-scaling and other details of robotic control.<bold>b</bold> Robotic instrument arms and Aesop endoscope arm (not
sterile-draped) at the operating table</p></caption><graphic xlink:href="11701_2006_7_Fig1_HTML" id="MO1"></graphic></fig><fig id="Fig2"><label>Fig. 2</label><caption><p>Zeus “MicroWrist” robotic instruments. This is a small sample of
available Zeus robotic instruments. This study used the micro-needle
holder shown at the<italic> far right</italic>, with a
jaw length of 7 mm, and overall “hand” length of 11 mm (<italic>line</italic>)</p></caption><graphic xlink:href="11701_2006_7_Fig2_HTML" id="MO2"></graphic></fig><fig id="Fig3"><label>Fig. 3</label><caption><p>Cervical approach for robotic endoscopic thyroidectomy. Surgical
set-up with ports in place, and superior cervical endoscopic approach for
robotic instruments and endoscope, with insufflation attached to
instrument port at right neck; non-survival series. Piglet in supine
position, with head toward top of figure</p></caption><graphic xlink:href="11701_2006_7_Fig3_HTML" id="MO3"></graphic></fig></p></sec></sec><sec id="Sec6" sec-type="results"><title>Results</title><sec id="Sec7"><title>Training and development</title><p>Training for computer-assisted robot-enhanced surgery requires demonstration
of improving times to perform a number of standard tasks on inanimate objects,
including forehand and backhand suturing and knot-tying with both right and left
hands. This phase of training exceeded 50 h and was followed by a variety of
surgical tasks on non-survival animals. Much of the development effort of Phase I
was spent optimizing robot arm placement, instrument port placement, and camera
placement, to optimize surgical access to the intracorporeal surgical workspace of
the central neck, and to minimize proximity conflicts of the extracorporeal
robotic apparatus. Overall, time logged on the Zeus surgical robot for both Phases
I and II of this study was greater than 120 h.</p></sec><sec id="Sec8"><title>Non-survival phase I</title><p>The entire surgical procedure was performed through incisions with a total
length of ≤23–11 mm for the camera port, and 5–6 mm for each of the two instrument
ports. It is worthy of note that the two instrument ports may be placed in the
axillae to minimize the length of incision in the neck for optimum cosmesis. We
experimented with this axillary approach during the Phase I non-survival series
but found that, although the pig lacks a clavicle thereby simplifying access to
the neck from the axillae, the sternal keel in pigs of extremely small size
interferes with thyroid access by this approach. This resulted in prohibitively
longer operative times and the inability to complete the procedure without
converting to the superior cervical approach. The axillary approach was therefore
abandoned in our smaller, survival series of infant piglets. This result is
similar to that recently reported by Terris’ group in a prospective evaluation of
various approaches to thyroidectomy in the porcine model [<xref ref-type="bibr" rid="CR32">32</xref>]. The porcine model is therefore limited to
demonstrating feasibility, and for human patients the axillary approach would be
considered for cosmetic reasons. Two intra-operative deaths occurred early in our
Phase I development—one apparently because of insufflation pressures (12 mmHg)
that interfered with cervical venous flow [<xref ref-type="bibr" rid="CR20">20</xref>, <xref ref-type="bibr" rid="CR34">34</xref>] and another
which occurred during mediastinal dissection that resulted in pressure against the
aortic arch by one of the robotic instruments. Post-mortem examinations of these
animals revealed no other injuries. All subsequent procedures were performed at an
insufflation pressure of 4 mmHg [<xref ref-type="bibr" rid="CR21">21</xref>,
<xref ref-type="bibr" rid="CR22">22</xref>, <xref ref-type="bibr" rid="CR34">34</xref>] All but four thyroid glands were successfully excised by use
of the robotic endoscopic surgical technique on the 16 non-survival piglets. An
early cohort of seven piglets enabled us to become familiar with the relevant
anatomy, determine appropriate positions for the pig and robot on the table and
for camera and port placement, trial the dissection balloons, refine dissection
techniques, and compare inferior cervical and axillary, and superior cervical
approaches. A later group of nine non-survival piglets was used to further refine
and standardize operative technique. Although we did not record operative times of
our first seven non-survival operations, the times decreased with experience over
the last nine animals for which times were recorded. On the basis of videotapes
and written logs for these procedures, operative times decreased from the longest
of 80 min to the shortest of 10 min during Phase I. An initial inferior approach
was unsuccessful despite trying a variety of instrument-port placements. After
switching to the superior approach we encountered difficulties in three cases that
prevented completion of thyroidectomy. The necks of these three non-survival
piglets during Phase I were dissected openly immediately after surgery to clarify
anatomic planes and identify areas for improvement. In two of these cases port
placement and/or dissection was too superficial, leading to problems with
perception of and access to the central neck compartment. These dissections
enabled us to confirm the anatomy and adjust camera and instrument placements for
optimum visualization and effective dissection in subsequent procedures.</p></sec><sec id="Sec9"><title>Survival phase II</title><p>In the survival cohort of eight piglets no conversions to open surgery were
necessary. There were no intra-operative complications in the survival series.
Overall, the robotic system was precise and thyroidectomy was readily performed in
infant piglets as small as 4.0 kg (Fig. <xref rid="Fig4" ref-type="fig">4</xref>). Total duration of the sterile operative procedure in survival
animals ranged from 83 to 119 min (Table <xref rid="Tab1" ref-type="table">1</xref>). As is evident from Table <xref rid="Tab1" ref-type="table">1</xref>, there was no appreciable trend toward improving operative
times during this survival series; this probably reflects the extensive training
that was achieved before and during the non-survival Phase I development period.
Unlike the human thyroid, the porcine thyroid lacks a significant neuro-vascular
association; analogous to the human thyroid, it is invested in a thin capsule,
lies deep to the midline strap musculature, within adipose tissue and fascia,
against the anterior tracheal wall. Despite the lack of need for vascular
ligation, we routinely surveyed the surgical cavity for hemorrhage after removal
of the thyroid (Fig. <xref rid="Fig4" ref-type="fig">4</xref>). We also performed
one-week survival follow up to confirm the safety and tolerance of the procedure
in the piglets. All survival animals resumed their regular diet within hours of
surgery, and continued water consumption, food consumption, and weight gain
(Table <xref rid="Tab1" ref-type="table">1</xref>) in parallel with a
non-operated cohort of age-matched infant piglets. <fig id="Fig4"><label>Fig. 4</label><caption><p>Endoscopic view during robotic endoscopic
thyroidectomy.<bold> a</bold> View immediately after
balloon dissection, insertion of robotic instruments, and insufflation.
Note long, narrow, anterior strap muscles, beneath which lies the
thyroid.<bold> b</bold> View at end of dissection
with the thyroid free and in the grasp of the right-hand instrument. For
size reference: instrument diameter is 5 mm; “jaw” length is
7 mm</p></caption><graphic xlink:href="11701_2006_7_Fig4_HTML" id="MO4"></graphic></fig><table-wrap id="Tab1"><label>Table 1</label><caption><p>Robotic endoscopic thyroidectomy in piglet model of the infant
neck, with operative times</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left">Piglet no.</th><th align="left">1</th><th align="left">2</th><th align="left">3</th><th align="left">4</th><th align="left">5</th><th align="left">6</th><th align="left">7</th><th align="left">8</th><th align="left">Mean</th><th align="left">SD</th></tr></thead><tbody><tr><td align="left">Weight at surgery (kg)</td><td align="left">9.1</td><td align="left">7.0</td><td align="left">4.2</td><td align="left">5.8</td><td align="left">4.9</td><td align="left">5.2</td><td align="left">4.0</td><td align="left">4.5</td><td align="left">5.6</td><td char="±" align="char">±1.7</td></tr><tr><td align="left">Weight 1 week post-op (kg)</td><td align="left">13.3</td><td align="left">9.1</td><td align="left">5.0</td><td align="left">6.3</td><td align="left">5.4</td><td align="left">7.0</td><td align="left">6.0</td><td align="left">5.9</td><td align="left">7.3</td><td char="±" align="char">±2.7</td></tr><tr><td align="left">Anesthesia time (min)</td><td align="left">111</td><td align="left">119</td><td align="left">83</td><td align="left">107</td><td align="left">92</td><td align="left">104</td><td align="left">103</td><td align="left">89</td><td align="left">101</td><td char="±" align="char">±12.1</td></tr><tr><td align="left">Robotic setup time (min)</td><td align="left">35</td><td align="left">32</td><td align="left">34</td><td align="left">37</td><td align="left">31</td><td align="left">39</td><td align="left">37</td><td align="left">35</td><td align="left">35</td><td char="±" align="char">±2.7</td></tr><tr><td align="left">Port placement (min)</td><td align="left">12</td><td align="left">15</td><td align="left">11</td><td align="left">10</td><td align="left">10</td><td align="left">11</td><td align="left">14</td><td align="left">21</td><td align="left">13</td><td char="±" align="char">±3.7</td></tr><tr><td align="left">Operating time (min)</td><td align="left">23</td><td align="left">40</td><td align="left">9</td><td align="left">31</td><td align="left">10</td><td align="left">22</td><td align="left">15</td><td align="left">8</td><td align="left">20</td><td char="±" align="char">±11.5</td></tr><tr><td align="left">Extract thyroid (min)</td><td align="left">3</td><td align="left">3</td><td align="left">2</td><td align="left">5</td><td align="left">3</td><td align="left">2</td><td align="left">6</td><td align="left">3</td><td align="left">3</td><td char="±" align="char">±1.4</td></tr><tr><td align="left">Close incisions (min)</td><td align="left">20</td><td align="left">13</td><td align="left">14</td><td align="left">11</td><td align="left">12</td><td align="left">14</td><td align="left">19</td><td align="left">10</td><td align="left">14</td><td char="±" align="char">±3.6</td></tr></tbody></table></table-wrap></p></sec><sec id="Sec10"><title>Complications</title><p>For two of the survival animals cervical subcutaneous emphysema was apparent
immediately after completion of the procedure; this dissipated over the following
24 h without sequelae. There were three minor complications in survival animals.
One animal (piglet no. 3 of 8) developed a superficial wound abscess with erythema
and purulence at the suture line of the left neck instrument port. This animal did
not develop fevers, did not appear bothered by the site, and did not alter its
diet, and thus the decision was made not to administer systemic antibiotics. The
wound was treated by application of topical antibiotic ointment, and local
swelling improved over the next two days. For all subsequent piglets in this
series, topical antibiotic ointment was applied to the three suture lines after
completion of surgery, and twice a day thereafter. One animal (piglet no. 7 of 8)
developed a midline seroma pocket at the area of the suprasternal notch, without
erythema or apparent discomfort. This animal did not develop fevers, did not alter
dietary intake, and did not require systemic antibiotics. After review of the
intra-operative video for this animal it became evident that the initial
subplatysmal trocar dissection for the endoscope was more superficial, and the
resulting tunnel longer, than was usual. It is uncertain whether this contributed
to formation of the seroma. Finally, one animal (piglet no. 8 of 8) developed
necrosis of a portion of thymus at the left neck instrument site, resulting in a
small, watery, non-purulent fluid collection in the left neck, noted on necropsy.
The pig thymus is situated longitudinally along either side of the trachea, and
the introduction of the left instrument trocar had traversed thymic tissue during
placement, resulting in this minor complication. There were no sequelae from this
injury during the one-week survival period. There were no major complications, and
no animal had to be surgically re-explored or euthanized as a result of
complications. These three minor complications did not interfere with
postoperative fluid or food consumption or growth until sacrifice at one week, and
might have been expected to resolve had they survived longer.</p></sec></sec><sec id="Sec11" sec-type="discussion"><title>Discussion</title><p>Minimally invasive techniques continue to revolutionize surgery. Endoscopic
techniques have become the standard surgical approach to many disease processes.
Robotic surgery has the potential to further extend minimally invasive surgical
techniques into ever smaller cavities, and into body spaces where there are no
natural cavities, for example the retroperitoneum or the neck fascial planes. In
this study we succeeded in performing robotic endoscopic neck surgery on an infant
piglet model as small as 4 kg, in an operative pocket volume as small as
2 cm<sup>3</sup>. There were no major complications and no robotic
instrument malfunctions or breakages requiring conversion to open surgery. As far as
we are aware this is the first report of a study of the feasibility of endoscopic
neck surgery in a model of this small size, and the first report of robotic
endoscopic surgery in a survival model of the infant neck. In our experience, the
most beneficial enhancements over traditional non-articulated endoscopic instruments
offered by robotic technology include tremor-filtration, magnification, motion
scaling from large operator movements down to microscopic movements at the level of
robotic surgical instruments, and, most significantly, addition of the wrist to the
endoscopic instruments. All surgeons have some tremor in the motion of their hands.
This can become particularly problematic under magnification, at the end of long
endoscopic instruments and during fine maneuvers in very small operative fields. The
computer interface of surgical robots filters these minuscule motions when
translating the surgeon’s hand movements at the controls to the instrument tips,
effectively eliminating tremors. The robotic interface can also translate extensive
movements by the surgeon’s hands at the controls to slower, smaller movements at the
level of the robotic instruments—”motion scaling”. This enhancement enables such
intuitive procedures as suturing and knot tying, especially within a very small
operative cavity during robotic endoscopic surgery. Although our thyroidectomy
porcine model did not require suturing or ligation, even simple tissue dissection
was greatly facilitated by the articulated instruments. At the time this work was
performed the Zeus surgical robotic system had several advantages over alternative
systems available during the development of the work [<xref ref-type="bibr" rid="CR27">27</xref>]. The other FDA-approved surgical robot available was the da
Vinci, manufactured by Intuitive Surgical (Sunnyvale, CA, USA). It also holds
minimally invasive instruments but differs from Zeus in several important features.
The da Vinci wrist is very fluid and responsive, and boasts a range of at least 90°
in two planes. It required 8-mm diameter instruments that had a minimum of 18.5 mm
“hand” length, however; 5-mm diameter instruments are now available, but they
require an even greater turning radius for the hand. This was the most limiting
feature of the da Vinci for our purpose of robotic endoscopic surgery in the infant
neck, where the workspace was often limited to a cube with a side of 20–25 mm. Zeus
instruments had a minimum jaw length of 7 mm, resulting in a “hand” size of 11 mm
(Fig. <xref rid="Fig2" ref-type="fig">2</xref>), but they moved through only 60°,
and are limited to only a single wrist plane of motion. Because of our intent to
model the human infant neck, we assumed an upper limit to neck width of 80 mm. Based
on the “hand” and wrist specifications of the two robotic systems, it became clear
that the da Vinci has a lower limit of distance between instrument ports of 100 mm;
Zeus had a lower inter-port limit of less than 30 mm [<xref ref-type="bibr" rid="CR27">27</xref>]. Thus, the da Vinci was not suited to our model. The lower
limits for endoscope-to-instrument-tip for the da Vinci (38 mm) were also outside
our theoretical limits for workspace dimensions (20–25 mm) whereas the Zeus (14 mm)
was within these limits [<xref ref-type="bibr" rid="CR27">27</xref>]. Since the
acquisition of Computer Motion by Intuitive Surgical in 2003, support for the Zeus
robotic system has been discontinued. It is, however, worthy of note that Intuitive
Surgical has stated a commitment to further develop the da Vinci system for
procedures in smaller surgical fields.</p><p>The total length of incision for all three ports in our survival animals was
23 mm, which is similar to reports for endoscopic neck surgery models in the
literature [<xref ref-type="bibr" rid="CR21">21</xref>, <xref ref-type="bibr" rid="CR22">22</xref>, <xref ref-type="bibr" rid="CR35">35</xref>]. This total may, however, be further reduced by using a 5 mm
endoscope, which Aesop does accommodate, and the da Vinci system has a 3D endoscope
with a diameter of 8 mm. This would bring the total incision length for the
procedure to 20 mm or less. The central endoscope incision was also the port used
for balloon dissection, however, and currently available dissection balloons require
a 10–11 mm incision. We found that this could be avoided simply by using blunt
dissection through a smaller incision. Using an axillary approach for the instrument
ports also has the potential to further reduce the length of incision in the neck,
to further optimize cosmesis. In adult-size pigs others have found this approach to
be feasible, albeit slower and more difficult [<xref ref-type="bibr" rid="CR32">32</xref>]. In Phase I with much smaller piglets we found the axillary
approach to be prohibitive using the surgical robot, because of the thyroid’s
location in relation to the sternal keel in the smaller animals. The axillary
approach has been successfully used for human non-robotic endoscopic thyroidectomy
[<xref ref-type="bibr" rid="CR36">36</xref>], however, and should be
considered for its potential cosmetic benefits as an approach for human robotic
endoscopic neck surgery.</p><p>Despite working with the smaller and more agile Zeus system, and despite
optimization and standardization of robotic arm placement and instrument angles,
painstakingly established during Phase I, we often experienced extra corporeal
instrument-arm-to-camera proximity conflicts and instrument–instrument–arm proximity
conflicts. This never resulted in termination or significant delay of the procedure;
it was merely an annoyance, resulting in minor limitation of range of motion of one
of the instruments. For infant piglets in the size range 4–6 kg, with inter-port
distances of 4–6 cm, we were, however, routinely working at the limits of the
available technology for robotic endoscopic neck surgery. Since discontinuation of
support for the Zeus surgical robotic system, it remains to be established what
proximity conflicts the larger remaining available robotic system, da Vinci, might
have in the confines of similar small models. It also remains to be determined
whether these potential proximity conflicts impose a real limit on robotic
endoscopic neck surgery in smaller animal models, or smaller human infant patients,
for which ports may be differently located because of anatomic disparities. Current
abilities would benefit greatly from development of software to guide port placement
with the goal of minimizing proximity conflicts.</p><p>As the safety and reliability of surgical robotics have become established, it
is evident they may have some advantages, although they remain limited by current
constraints. Further development and miniaturization may resolve some current
limitations that we encountered. We have not introduced the issue of cost, but this
will weigh heavily in the trend toward minimally invasive robotic surgery. With a
single surgical robotic system costing over US $1 million, significantly lower
morbidity and quicker recovery will need to be demonstrated to justify use of these
systems. For some surgical procedures it seems that robotic surgery has met that
test, and is the evolving standard surgical approach [<xref ref-type="bibr" rid="CR28">28</xref>, <xref ref-type="bibr" rid="CR37">37</xref>]. Whether there
will be sufficient justification for application of computer-assisted surgical
robots to endoscopic neck procedures remains to be determined. Pioneering work by
other groups will help determine the value of robotic endoscopic surgery in the head
and neck [<xref ref-type="bibr" rid="CR38">38</xref>–<xref ref-type="bibr" rid="CR40">40</xref>]. The infant porcine neck model described here
establishes the feasibility of performing computer-assisted robot-enhanced
endoscopic surgery in a neck the size of a human infant’s. For the pediatric
surgeon, robotic endoscopic surgery can help optimize the advantages of
minimally-invasive techniques. It is uncertain at this time which surgical
procedures may benefit most from the robotic endoscopic technique in human infants
or children. We expect, however, that, as was found for early laparoscopic methods,
clinical applications may evolve from this initial demonstration of ability. It is
our hope that the infant porcine neck model described here will provide inspiration
and incentive for further development of the tools and techniques for application of
robotic technology to pediatric head and neck surgery.</p></sec><sec sec-type="supplementary-material"><title>Electronic supplementary material</title><sec id="SecESM1"><supplementary-material content-type="local-data" id="MOESM1"><media xlink:href="11701_2006_7_MOESM1_ESM.mpg"><caption><p><bold>Start of procedure: Endoscopic Robotic
Thyroidectomy in Piglet. Instruments</bold>: Zeus 5 mm diameter
robotic instruments, micro-needle drivers, used for blunt dissection.
<bold>Orientation</bold>: superior is toward the
endoscope; away from the endoscope is the sternum, where the strap
muscles attach distally in this view. The thyroid lies midline on the
anterior tracheal wall between these strap muscles. Laterally on either
side of the strap muscles lie the two areas of thymus tissue, seen here
as whitish. <bold>Dissection</bold>: Note slow
dissection by grasping fascial sheets between two instruments and
pulling. Tissues are gripped for short pause before separating with the
goal of improving hemostasis by crushing small vessels (MPEG 71.8
Mb)</p></caption></media></supplementary-material><supplementary-material content-type="local-data" id="MOESM2"><media xlink:href="11701_2006_7_MOESM2_ESM.mpg"><caption><p><bold>Continued dissection</bold>. The
thyroid is dissected completely off anterior tracheal wall. The next
step will be to replace one of the robotic instruments (in this case,
the left-hand instrument) with a 5 mm diameter endoscope, and to replace
the 10 mm centrally-located endoscope with a large grasping forceps, to
recover and extract the thyroid (MPEG 14.4 Mb)</p></caption></media></supplementary-material><supplementary-material content-type="local-data" id="MOESM3"><media xlink:href="11701_2006_7_MOESM3_ESM.mpg"><caption><p><bold>Removal of thyroid through endoscope
port</bold>. The camera view here is using a 5 mm endoscope
through the left neck port, while a grasping instrument is inserted
through the main 10 mm endoscope port to withdraw the thyroid (MPEG 12.1
Mb)</p></caption></media></supplementary-material><supplementary-material content-type="local-data" id="MOESM4"><media xlink:href="11701_2006_7_MOESM4_ESM.mpg"><caption><p><bold>Endoscopic exploration of the
wound.</bold> The endoscope is re-inserted through the central
port and the operative space re-insufflated to assure hemostasis. The
wound is “explored” using the robotic instruments, drawing the strap
muscles to the side to thoroughly view the thyroidectomy site and the
anterior tracheal wall, inspecting for hemorrhage. There is good
hemostasis. The instruments are now withdrawn, the wounds closed, and
the piglet awakened (MPEG 32.4 Mb)</p></caption></media></supplementary-material></sec></sec></body><back><ack><p>A portion of this study was presented as a Candidate’s Thesis (R.A. Faust)
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