The Cleft Palate–Craniofacial Journal 00(00) pp.

000–000 Month 2015

! Copyright 2015 American Cleft Palate–Craniofacial Association

Article type: ORIGINAL ARTICLE

Transoral Robotic Cleft Palate Surgery

Nasser Nadjmi, M.D., D.D.S., Ph.D.

Objective: This study aimed to assess the safety and feasibility of transoral robotic surgery
for the reconstruction of soft palatal clefts.
Design: The application of transoral robotic surgery for soft palate muscle reconstruction
was investigated. The da Vinci Surgical Robot was first used on a cadaver to assess the optimal
positioning of the patient and the robot. The robot was then used for the dissection and
reconstruction of palatal muscles in 10 consecutive patients with palatal clefts. The procedures
were documented using video and still photography. A group of 30 control patients were
subjected to surgery with manual instruments. Surgical and clinical outcomes were evaluated
with at least 6 months of follow-up (8 6 1 months).
Results: The use of the surgical robot on a cadaver provided great dexterity and excellent 3D
depth perception. The transoral access was efficient and safe for the precise dissection,
reorientation, and suturing of palatal muscles. In our series, the surgical duration was longer for
the robotic approach than for the manual approach (87 6 6 minutes versus 122 6 8 minutes, P ,
.0001). No intraoperative or postoperative complications occurred in either group.
Conclusions: A robotic surgical approach can be used safely for palatal surgery. We believe
that the precise dissection of the palatal muscles provided by the robotic system might reduce
damage to the vascularization and innervation of these muscles, as well as damage to the
mucosal surfaces that could cause fistula formation. In addition, this technique might improve
palatal function and Eustachian tube function in cleft palate patients.

KEY WORDS: transoral robotic surgery, robotic surgery, cleft palate, palatal surgery

The goals for treating the patient with a cleft palate are to not occur for many years (Smith et al., 1994). A recent study
achieve normal speech, hearing, and maxillofacial growth reported excellent speech outcomes and normal maxillary
and to avoid fistulas. Palatal muscle reconstruction in cleft growth without fistula formation during a mid- to long-
palate patients confers better functional results with respect term follow-up period using a fundamentally modified
to velopharyngeal competence and Eustachian tube double-opposing Z-plasty technique (Nadjmi et al., 2012).
function. Although most children with cleft palates Those authors strongly believe that proper palatal-muscle
eventually recover normal Eustachian tube function after repair is of paramount importance for a good surgical
palatoplasty, for the majority of children, this recovery does outcome after cleft palate repair.
Robot-assisted surgery has gained popularity in the head
and neck field due to the appeal of utilizing a minimally
Dr. Nadjmi is Professor and Coordinating Program Director invasive approach, obtaining excellent visualization, and
OMFS, Department of Cranio-Maxillofacial Surgery, University of
Antwerp/AZ MONICA Campus Antwerpen, Belgium. the overall low risks of the procedures. Previous preclinical
There was no financial support for this study. and clinical studies demonstrated the safety, feasibility, and
Presented at the autumn meeting of the Royal Belgian Society for early success of transoral robotic surgery (TORS) in
Stomatology and Maxillofacial Surgery, Namen, Belgium, November
16–17, 2012; 21st Annual Congress of Iranian Society of Pediatric supraglottic laryngectomy, radical tonsillectomy, and
Surgeons, Tehran, Iran, May 5–8, 2013; Robotic surgery and its partial pharyngectomy procedures in patients with head
alternatives in the head and neck, a meeting of The Royal Society of and neck cancer, parapharyngeal tumors, and skull base
Medicine, London, U.K., October 24, 2013; the Scientific Meeting of
Dutch Association for Cleft Palate and Craniofacial Anomalies, tumors requiring resection (Hockstein et al., 2005; Hock-
Ghent, Belgium, November 16, 2013; the VIII World Cleft Congress of stein et al., 2006; O’Malley et al., 2006; O’Malley and
the International Cleft Lip and Palate Foundation, Hanoi, Vietnam,
November 25–28, 2013; and the 12th International Congress of the
Weinstein, 2007; Weinstein et al., 2007). Despite these
Iranian Society of Oral & Maxillofacial Surgeons, Tehran, Iran, recent advances, to the best of our knowledge, the
February 26–28, 2014. introduction of surgical robotics to the field of cleft surgery
Submitted March 2014; Revised September 2014, December 2014;
Accepted February 2015. has not been reported in the clinical setting. The only study
Address correspondence to: Dr. Nasser Nadjmi, Department of published in this field presented the applicability of
Cranio-Maxillofacial Surgery, AZ MONICA Campus Antwerpen, transoral robotic cleft palate surgery (TORCS) for
Harmoniestraat 68, 2018 Antwerp, Belgium. E-mail nasser@nadjmi.
com. pharyngeal flap surgery on cadavers, so clinical outcomes
DOI: 10.1597/14-077 could not be assessed (Smartt et al., 2013). The aim of the

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different instruments, including needle drivers, bipolar

forceps, and Maryland forceps. The surgeon’s console,
which contained a 3D viewing screen and hand controls
for the robot, was located a few feet away against the
wall. An essential component of this procedure was to
evaluate the ability of the surgeon to view the soft palate
cleft at full length and to manipulate the two robotic
arms without interfering with the Dingman retractor.

Clinical Trials

Once the application of the approach had been

verified in a cadaver simulation, the procedure was
attempted in a clinical setting.
The da Vinci robotic approach was utilized for the
dissection and reconstruction of palatal muscles in 10
consecutive cleft patients at our institution beginning
April 2012. The included patients were six males and
four females. The principles outlined in the Declaration
of Helsinki were followed. All subjects were informed
about the available treatment options, and informed
consent was obtained. The mean age of these patients
was 9.5 months (age range: 9 to 12 months). Of the
included patients, five patients had isolated cleft palate,
two patients had complete unilateral cleft lip and palate,
two patients had complete bilateral cleft lip and palate,
and one patient had submucosal cleft palate. A modified
FIGURE 1 A: Positioning of the surgical cart during a cadaver Furlow palatoplasty was used to reconstruct soft palate
experiment. B: Robotic-arm positioning in the oral cavity of a cadaver. clefts (Nadjmi et al., 2012).
All patients were anesthetized and placed in the supine
present study is to evaluate the appositeness and technical position with their heads in 158 extension. The orotracheal
feasibility of the da Vinci Surgical Robot for the tube was positioned in the midline of the lower lip and
reconstruction of soft palatal clefts and to appraise the secured to the chin using tape. The operating table was
resulting clinical outcomes. then rotated 1808 away from the anesthesiologist’s field.
The da Vinci Surgical Robot was introduced into the
MATERIALS AND METHODS surgical field and positioned on the right side of the
patient. This positioning provides a free space for the
Cadaver Trials assistant at the head of the bed (Fig. 2A).
Two articulating robotic arms were positioned intra-
After reviewing the current literature on TORS, we orally along with the 308 endoscope. Using robotic
performed a robot-assisted palatal muscle dissection on control, the endoscope was manipulated to provide
a cadaver to evaluate the application and expediency of adequate visualization of the oral cavity and soft palate
the utilization of the da Vinci Surgical Robot (Intuitive (Fig. 2B). The 8-mm EndoWirst instruments were
Surgical Inc., Sunnyvale, CA) in cleft patients at the time utilized. These instruments consisted of a pair of Hot
of soft palate reconstruction. A dentate female cadaver Shears (monopolar curved scissors; Company Name,
was placed in the supine position on an operating room City, ST), DeBakey forceps, a large SutureCut needle
table. The oral cavity and the soft palate were exposed driver (Company Name, City, ST), and fine tissue
using a Dingman retractor. The surgical robotic cart was forceps. The Hot Shears and DeBakey forceps were
positioned in alignment with the operating table at the used for tissue dissection, and the needle driver and fine
head of the cadaver (Figs. 1A and 1B). tissue forceps were used for the suturing of the muscles.
One arm held a 308 12 mm stereoscopic camera, and The levator muscles were then united in an end-to-end
two of the three remaining arms held EndoWirst fashion, usually in the posterior half of the velum, using
instruments (Intuitive Surgical Inc.). Both 5-mm and 4-0 PDS sutures. The nasal and oral layers were sutured
8-mm instruments were used to determine the extent of using surgical loupes, with a 2.53 magnification.
the range of motion. The lateral arms of the robot were Introducing a third limb of the robot appeared to be
interchangeable, so as to be used for a variety of impossible due to the limited space available through
 Nadjmi, ROBOTIC CLEFT PALATE SURGERY 0

FIGURE 2 A: Operation room setup. B: Robotic-arm positioning in the oral cavity. C: Surgeon sitting ergonomically at the console.

the oral cavity. Therefore, suctioning was performed by their appearance was markedly distinguishable and the
an assistant, who sat ergonometrically at the head of the muscles were separated by different fat pads. The palatal
patient and could follow the procedures on a monitor. muscles were resutured in the midline using two robotic
Upon completion of the surgery, all robotic instru- arms that entered the oral cavity laterally alongside the
ments, endoscopes, and retractors were removed with- corners of the mouth. The robotic instruments could be
out inadvertent trauma or injury to the patient. All manipulated at all times without interfering with the
mucosal incisions were closed primarily. Dingman retractor. Both 5-mm and 8-mm instruments
To evaluate the surgical duration and outcomes of provided sufficient degrees of range of motion. As the same
TORCS, a group of 30 patients, who were matched retractor is commonly used in pediatric patients, we
according to sex, age, and diagnosis, were assessed. The assumed that the robotic instruments could safely be
control group underwent the same technique with utilized in cleft patients.
manual instruments. All cases were followed for at least The use of TORCS in pediatric cleft patients afforded the
6 months postoperatively (8 6 1 months). surgeons enhanced dexterity and precision, delicate soft
tissue handling, excellent 3D depth perception, and
RESULTS relatively easy intraoral suturing (Fig. 3).
TORCS could be used in all cleft patients. The initial
In the cadaver study, the mucosa and the submucosal setup of the surgical suite for the robotic equipment was
tissue were dissected away from the underlying muscles of accomplished in 35 minutes. This setup was completed
the soft palate. These muscles could be clearly identified, as during the preparation and intubation of the patients.
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FIGURE 3 A: Intraoperative view of the left palatal-muscle dissection. B: Intraoperative view of the left levator veli palatini muscle dissection from the
nasal mucosal layer. C: Intraoperative view of the dissection of the right levator muscle. D: Intraoperative view of the levator sling reconstruction. E:
Intraoral view of the palate at completion of the surgery.

Excellent exposure was achieved using an upward 308 All patients regained normal swallowing function on the
endoscope. Induction, intubation, and preparation of the day of surgery. During postoperative follow-up, there were
patient for the surgery were completed during this time. no complications in either group.
The mean surgical duration for the control group was 87
6 6 minutes; the surgical duration was 122 6 8 minutes in DISCUSSION
patients who underwent the TORCS approach. The P
value calculated using a 2-tailed t test was ,.0001, A proper palatal muscle repair is of paramount
demonstrating that the use of TORCS resulted in a importance for a good surgical outcome after cleft palate
significantly (power 80%, significant P value , .05) longer repair. This outcome is considered to be optimal when
duration. improved function is achieved with respect to velopharyn-
Additionally, the duration of hospitalization was signif- geal competence and Eustachian tube function.
icantly shorter in the included patients (1 versus 2.4 6 1.3; In the approach presented here, an adequate retroposi-
P ¼ .0017). tioning of the levator muscles is achieved without
There were no intraoperative complications. detachment of the nasal mucosa from the levator muscle
All patients were discharged on the first postoperative on the right side and without detachment of the oral
day. In the first patient, a partial dehiscence of the mucosal mucosa from the levator muscle on the left side. Robotic
wound closure was observed that resolved spontaneously. assistance facilitates the dissection of the levator muscle
 Nadjmi, ROBOTIC CLEFT PALATE SURGERY 0

from the tensor tendon anteriorly and the palatoglossus instruments may provide greater opportunities for palatal
and palatopharyngeus muscles posteriorly. surgeries. Unfortunately, the high cost of the robotic
We hypothesized that the preservation of the innervation equipment limits its routine presence and use in most
and vascularization of the palatal muscles during their operating rooms around the globe. This limitation calls for
dissection, reorientation, and suturing might optimize the development of smaller, less-expensive, and portable
Eustachian tube function. Surgical robots provide 3D robotic platforms that are user-friendly, as well as specific
endoscopic vision, which gives the surgeon true depth instruments tailored for head and neck surgery. We believe
perception. This vision provides increased freedom of that the development of smaller instruments and further
motion for the microendoscopic instruments, including advances and modifications will facilitate the incorporation
simulated flexion, extension, pronation, and supination of of robotic equipment into TORCS. The other potential
the instruments. The aforementioned advantages facilitate advantage afforded by the imaging capabilities of the robot
more-delicate handling of soft tissues and increased surgical is relevant for training and teaching purposes. This
precision (Haus et al., 2003; Hockstein et al., 2005). modality is still in its infancy, and to improve safety,
Furthermore, robotic equipment incorporates the scaling formal training courses must be established, in the same
of movement, translating large movements of the hands manner that such innovations occurred when endoscopic
into small movements of the instruments, thus filtering surgery was introduced in the 1990s. With recent advances
tremor. An ergonomic position on the surgeon’s console in telecommunication and the 3D imaging available on the
eliminates the unnatural and uncomfortable body postures surgical cart, the surgical view could be transferred to large
that occur during conventional palatal surgery, which 3D screens anywhere in the world.
might affect the outcome of the operation (Fig. 2C). Our Our series revealed a longer surgical duration while using
preclinical experiments in a cadaver supported the hypoth- the TORCS approach. Nevertheless, we encountered no
esis that TORCS is technically feasible and can be applied infections or other complications related to prolonged
to the reconstruction of the palatal muscle sling. surgical duration. Future large-scale studies are required to
Although robotic thyroidectomy surgery has been prove the safety and risk efficiency of this approach.
reported in children (Lobe et al., 2005; Miyano et al., Furthermore, the introduced TORCS surgical technique
2007), studies of robotic surgery in the pediatric population could be used in the same setting for velopharyngeal
are rare. To date, the only pediatric case series on this topic surgery.
was described by Rahbar et al. (2007) at Children’s
Hospital Boston. In this study, two patients with type 1 CONCLUSION
and type 2 laryngeal clefts underwent successful surgical
repairs using the robotic system. Therefore, we decided to We demonstrated in 10 pediatric cleft patients that
evaluate the application, efficacy, and feasibility of the da exposure using a Dingman mouth gag, visualization using
Vinci Surgical Robot for the reconstruction of soft palatal an upward 308 endoscope, and manipulation of tissues with
clefts. Based on the cadaver study, we found that the best robotic assistance allowed for successful dissection of the
exposure and an adequate range of motion could be palatal muscles. The advantages of robotic-assisted surgery
achieved using the Dingman mouth gag combined with the compared with the conventional procedure include 3D
3D, 308 endoscope and the 5-mm and 8-mm instruments for vision, a high degree of precision with increased freedom of
work on the soft palate. We also found that intraoral instrument movement, and tremor filtration. Based on our
suturing with the robotic equipment was relatively easy preclinical work and the results achieved with our first
once an adequate exposure was achieved. We demonstrated pediatric cleft patients, we believe that TORCS is
that the 308 angled, high-magnification 3D camera optics technically feasible.
permitted tremendous visualization, which facilitated the In conclusion, our findings suggest that TORCS holds
careful identification and dissection of the palatal muscles potential for the reconstruction of palatal muscles in cleft
in our cleft patients. palate patients, but further instrument development and
One potential disadvantage of the robotic surgical system
continued investigations are of paramount importance.
is the lack of ‘‘natural’’ tactile feedback. Although there
Future large-scale studies are required to ensure the safety
were no significant complications in this series, there is a
of this approach.
real risk of tearing the delicate palatal tissue in the hands of
an inexperienced surgeon. The high-resolution 3D imaging
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