Received: 14 February 2018 Revised: 5 June 2018 Accepted: 15 August 2018

DOI: 10.1002/hed.25455

ORIGINAL ARTICLE

Prospective instrumental evaluation of swallowing, tongue

function, and QOL measures following transoral robotic surgery
alone without adjuvant therapy
Cathy L. Lazarus PhD1,2 | Cindy Ganz MS1,2 | Meng Ru MS3 | Brett A. Miles DDS, MD2 |
Tamar Kotz MS2 | Raymond L. Chai MD1,2

1
THANC Foundation, New York, New York
2
Departments of Otolaryngology-Head & Neck
Surgery, Mount Sinai Health System, New York,
New York
3
Population Health Science & Policy, Icahn
School of Medicine at Mount Sinai, New York,
New York
Correspondence
Cathy L. Lazarus, Department of Otolaryngology
Head & Neck Surgery, Mount Sinai Beth Israel,
10 Union Square East Suite 5B, New York, NY
10003.
Email: cathy.lazarus@mountsinai.org
Funding information
Icahn School of Medicine at Mount Sinai, Grant/
Award Number: P30 CA196521-01
Abstract
Background: Transoral robotic surgery (TORS) has been utilized to deintensify
treatment. No studies have measured swallow safety and efficiency, nor assessed
the functional impact of TORS alone.
Methods: This prospective cohort underwent baseline and 1-month postsurgery
assessments including modified barium swallow evaluation, using the Dynamic
Imaging Grade of Swallowing Toxicity (DIGEST) rating system, tongue range of
motion assessment, the Performance Status Scale (PSS), and quality of life with the
MD Anderson Dysphagia Inventory (MDADI).
Results: All DIGEST safety scores were 0 (normal) at both time points. DIGEST
efficiency scores were mildly impaired in 2 of 10 patients postsurgery. PSS scores
revealed all patients were on regular diets, were 100% understandable, and were
eating in public at both time points. Tongue Range of Motion scores were 100 of
100 at both time points. MDADI scores were not significantly different across time
points.
Conclusions: Careful identification of patients can result in excellent outcomes fol-
lowing TORS. Future studies will examine longer follow-up of speech, swallow-
ing, and tongue function in patients undergoing TORS surgery.

KEYWORDS

DIGEST, head and neck cancer, outcomes, quality of life, swallowing, TORS

1 | INTRODUCTION More recently, transoral robotic surgery (TORS) has been

Surgery with traditional open techniques such as transman-
dibular and transcervical pharyngotomy has historically been
utilized to access and resect oropharyngeal tumors.1–3 How-
ever, these approaches can result in significant functional
morbidity.4–6 Chemoradiotherapy protocols were developed
to reduce morbidity following surgical approaches, with
comparable locoregional control and survival.7–9 However,
swallow impairment, altered diet, inability to take oral nutri-
tion, and impaired quality of life (QOL) are common and
debilitating side effects of primary chemoradiotherapy.10–18
utilized, with the primary benefit being a minimally invasive
platform for pathologic risk stratification to potentially dein-
tensify overall treatment. Prior studies have shown high rates
of locoregional tumor control, low complication rates, and
decreased length of stay with TORS.19–23 Further, swallow-
ing function has been found to be preserved, with return
to oral intake and preoperative oral diets following
surgery.24,25
Despite these promising data, few studies have documen-
ted objective swallowing function in this population, with
only 2 utilizing instrumental examination of swallowing.

Head & Neck. 2018;1–7. wileyonlinelibrary.com/journal/hed © 2018 Wiley Periodicals, Inc. 1

2 LAZARUS ET AL.
These studies focused only on aspiration and velopharyngeal
reflux rather than a more comprehensive evaluation of swal-
lowing function.26,27 Further, although time to oral diet, diet
type, and need for percutaneous endoscopic gastrostomy
(PEG) placement have been examined in patients undergoing
TORS,26 no studies have measured swallow functioning in
terms of safety and efficiency after TORS procedures. Finally,
many of these studies include evaluation of patients after adju-
vant therapy and do not assess the functional impact of TORS
alone on swallowing.25,26,28–31
The purpose of this investigation was to utilize both
objective and subjective validated swallowing measures to
prospectively investigate how TORS alone, without the
impact of adjuvant treatment, affects tongue function, swal-
low functioning and QOL. All patients in the study were re-
assessed at 1 month following surgery to both allow for a
reasonable amount of time for adequate healing as well as to
assess patients in the window of time before any potential
adjuvant therapy was started. We hypothesized that TORS
would result in minimal impairment in tongue function,
swallowing, and patient-rated QOL, with return to near-
baseline swallowing function by 1 month postoperatively.
2 | M AT E R IA L S A ND M E T H O DS
This Institutional Review Board (IRB)-approved prospective
study was conducted at Mount Sinai Beth Israel in
New York City and all patients provided written informed
consent. Patients were referred consecutively by 2 physicians
on the team who are trained in and perform TORS proce-
dures (BAM, RLC). Inclusion criteria included all males and
females over 21 years of age with newly diagnosed oropha-
ryngeal tumors including tonsil, tongue base, soft palate, lat-
eral pharyngeal wall, and/or valleculae who were deemed
appropriate for TORS surgery. Candidates were selected on
the basis of anatomic resectability and high potential to
receive deintensified treatment (either no adjuvant therapy or
adjuvant radiotherapy alone without chemotherapy). All
patients undergoing TORS were discussed in a multidisci-
plinary tumor board prior to surgery, with consensus opinion
to proceed with surgical resection. Subjects with local neck
metastasis were included in this study. Subjects were
excluded if they had a history of stroke or other acute (eg,
subarachnoid hemorrhage, subdural hematoma, and traumatic
brain injury) neurologic insult or degenerative neurologic dis-
ease (eg, amyotrophic lateral sclerosis (ALS) and Parkinson's
disease) that might adversely affect swallowing. Patients who
previously underwent prior treatment for head and neck can-
cer were excluded, as were those who demonstrated any med-
ical condition that might limit the patient's ability to follow
the protocol. Demographic and medical information including
age, sex, tumor site, stage, pathology, and human papilloma-
virus (HPV) status was collected for all patients. Time to initi-
ation of oral intake postsurgery was recorded for all patients.
All patients underwent a standardized extent of resection as
described by Weinstein et al.21 Patients with tonsil primaries
underwent radical lateral oropharyngectomy whereas patients
with base of tongue (BOT) primaries underwent tongue base
resections. All surgeries represent en bloc resections with neg-
ative circumferential margins on pathology.
2.1 | Assessments
2.1.1 | Modified barium swallow (MBS) procedure
Each patient underwent MBS evaluation of swallowing32,33
before surgery and 1-month postsurgery. The MBS proce-
dure was used to examine the safety and efficiency of the
swallow. The patients were initially viewed in the lateral
plane, with 2 swallows each of 5 mL thin liquid barium via
cup, 10 mL thin liquid barium via cup, 2 uncalibrated cup
sips, 1 swallow each of 5 and 10 mL nectar-thick liquid via
cup, 5 mL Varibar (Bracco Diagnostics, Inc., Monroe
Township, NJ, USA) pudding via spoon, and half Lorna
Doone butter cookie coated with 2 mL pudding barium.
One swallow of 5 mL nectar-thick liquid in the anterior-
posterior view was administered to examine medial move-
ment of the lateral pharyngeal walls and 1 swallow of 5 mL
pudding to examine transit and clearance of the bolus through
the esophagus. Fluoroscopy data were digitally recorded at
30 frames per second on the Kay-Pentax Swallow Workstation
for slow motion and frame-by-frame viewing. Audio input was
captured with a microphone. During the study, the fluoroscopy
tube was focused on the lips anteriorly, the posterior pharyn-
geal wall posteriorly, the soft palate superiorly, and the bifurca-
tion of the esophagus and the airway inferiorly. As is standard
during the MBS study, if aspiration was to occur on the first
swallow of a 5, 10 mL, or uncalibrated cup sip of thin liquid
bolus, the second swallow would be completed using a postural
technique in an attempt to eliminate the aspiration. If the aspira-
tion was not eliminated, a maneuver (with or without a posture)
would be attempted to eliminate aspiration, as is standard clini-
cal practice. The MBS was jointly conducted with a radiologist
and a speech-language pathologist.
Swallow function from the MBS studies was assessed
using the Dynamic Imaging Grade of Swallowing Toxicity
(DIGEST) scale, a scale designed to provide a global score of
swallow safety and efficiency that has been validated in the
head and neck cancer population.34 DIGEST safety scores
were based on the Penetration/Aspiration Scale.35 DIGEST
safety and efficiency ratings were completed and total
DIGEST score was obtained for each patient at both time
points from the MBS assessments. The DIGEST scores were
independently calculated from the MBS study by 2 speech
pathologists, with interjudge reliability assessed by Cohen's
Kappa coefficient (unweighted kappa) and 95% confidence
intervals (CIs). The criteria for the kappa coefficient by Lan-
dis and Koch were adopted to interpret the results:
<0.2 = slight agreement, 0.21-0.40 = fair, 0.41-0.60 = mod-
erate, 0.61-0.80 = substantial. and 0.81-0.99 = almost
LAZARUS ET AL. 3

perfect.40 All MBS studies were re-reviewed 2 weeks later to
examine intrajudge reliability.
2.1.2 | Tongue function, performance status, and MDADI
QOL measures
All assessments were completed both at baseline and 1-month
postsurgery. Tongue range of motion was assessed using the
Tongue Range of Motion (ROM) composite score, which pro-
vides a mean composite score for tongue range of motion on
protrusion, lateralization, and tip elevation.36 Type of intake
(oral vs nonoral) was documented, as was percentage of oral
intake if the patient underwent PEG placement. Specific diet
type was documented with the Performance Status Scale
(PSS) Normalcy of Diet Subscale that includes a breakdown
of specific types of foods and liquids on a scale of zero to
100,37 with 0 indicating nothing by mouth and 100 indicating
a regular diet with no restrictions. Speech understandability
was scored with the PSS Understandability of Speech sub-
scale, a clinician-rated score that quantifies the degree of
understandability, ranging from 0 (indicating never under-
standable) to 100 (indicating always understandable).37 Abil-
ity to eat in public was scored with the PSS Eating in Public
Subscale, a scale that ranges from 0 (indicating that the patient
always eats alone) to 100 (indicating no restriction of place,
food, or companion).37
Patient-rated swallowing QOL was examined using the
MD Anderson Dysphagia Inventory (MDADI),38 a scale that
includes a 5-point rating system, with higher scores indicat-
ing better functioning. This scale includes a composite score,
global score, and 3 subscales, including physical, emotional,
and functional; all were examined in this study. A score of
≥80 indicates minimal or no swallowing problems.39
2.2 | Statistical analyses
MBS DIGEST scores were summarized by frequency and
all other continuous measurements (PSS diet, speech under-
standability, eating in public scores, tongue composite
scores, percent oral intake, and MDADI scores) were sum-
marized by mean (SD) at baseline and 1 month postsurgery.
Paired t tests were used to examine continuous outcomes for
presurgery and postsurgery. Changes of these scores from
presurgery to postsurgery and 95% CIs were estimated by
univariate repeated-measures mixed-effects models. Statisti-
cal significance was considered at P < .05. All statistical
analysis procedures were performed using SAS 9.4 software
package (SAS Institute Inc., Cary, North Carolina).
3 | RESULTS
Ten patients (5 male and 5 female), age range 39-79 years
(median age: 61) participated in this study (Table 1). Tumor
site included 5 BOT and 5 tonsil primaries. American Joint
Committee on Cancer (AJCC) 7th edition TNM staging,
composite disease stage, HPV status, and structures included
in the surgical resection can be found in Table 1. The major-
ity of patients demonstrated stage IV disease (N = 7), with
2 having stage II disease and 1 patient with stage III disease.
HPV status was positive for all patients. Nine patients under-
went neck dissection, with 8 being unilateral and 1 bilateral,
with 4 of 8 undergoing staged neck dissection and TORS
(Table 1). Size and status of nodes and primary tumor size
and status of margins can be found in Table 2.
3.1 | Surgical details
All tumors were well-lateralized and deemed preoperatively
as appropriate candidates for en bloc resection with wide
negative margins. All primary tumors were AJCC 7th edi-
tion T1 or T2. For radical tonsillectomy, a standardized
approach was used as per Weinstein et al.40 All patients
undergoing radical tonsillectomy had a standardized defect
including limited soft palate resection, en bloc removal of
superior constrictor muscle from parapharyngeal space, and
limited BOT resection for inferior margin. No patient's

TABLE 1 Patient age, sex, tumor site, histology, T/N/M classification (AJCC 7th edition), stage of disease (dz), HPV status, surgery, presence of neck
dissection (ND) and whether staged, presence of adjuvant (adj) radiotherapy (XRT), and chemoradiotherapy (CRT)
Neck Staged ND
Patient Tumor Tumor T/N/M Stage HPV dissection? and TORS? Adjuvant Adj
No Sex Age site histology classification of Dz status Surgery Yes/No Y/N XRT? CRT?
OO1 M 61 Tonsil SCCA T1N1M0 III Positive Radical oropharyngectomy Yes Yes NO NO
OO2 F 61 BOT SCCA T2N0M0 II Positive BOT resection No N/A NO NO
OO3 M 54 BOT SCCA T2N2bM0 IVA Positive BOT resection Yes Yes YES NO
OO4 F 79 BOT SCCA T2N2aM0 IVA Positive BOT resection Yes Yes YES NO
OO5 F 65 Tonsil SCCA T2N2bM0 IVA Positive Radical oropharyngecctomy Yes Yes NO NO
OO6 M 76 BOT SCCA T1N2bM0 IVA Positive BOT resection, ipsilateral Yes No YES NO
palatine tonsillectomy
OO7 F 55 Tonsil SCCA T2N0M0 II Positive Radical oropharyngectomy Yes No NO NO
OO8 M 39 Tonsil SCCA T1N2aM0 IVA Positive Radical oropharyngectomy Yes No NO NO
OO9 F 60 BOT SCCA T1N2aM0 IVA Positive BOT resection Yes No YES NO
O1O M 56 Tonsil SCCA T2N2aM0 IVA Positive Radical oropharyngectomy Yes No YES NO

Abbreviation: TORS, transoral robotic surgery.

4 LAZARUS ET AL.

TABLE 2 Transoral robotic surgery (TORS) surgical details, including unilateral versus bilateral, size and status of nodes, TORS surgery type, primary
tumor size, and margin status
Patient No Details of neck dissection, TORS surgery, pathology of neck nodes, size of tumor and margin status
OO1 Prior excisional nodal biopsy with 1 positive node. Staged ipsilateral neck dissection - no additional nodes. TORS = right radical
tonsillectomy. Tumor 1.2 cm, widely negative margins.
OO2 Prior debulking biopsy at OSH. TORS base of tongue resection to clear margin. No residual carcinoma in specimen.
OO3 Staged ipsilateral neck dissection - 2/19 nodes positive, largest 3.5 cm. TORS - base of tongue resection. Tumor 4 cm, widely negative
margins.
OO4 Staged ipsilateral neck dissection - 1 positive node (largest 4.2 cm). TORS - base of tongue resection. 2.1 cm, widely negative margins
OO5 Prior tonsillectomy at OSH hospital, staged ipsilateral neck dissection—1 positive node, 4 cm. TORS—radical tonsillectomy (no residual
tumor)
OO6 Neck dissection—2 positive nodes, largest 2.9 cm. Base of tongue—1.1 cm, 5 mm depth
OO7 Neck dissection—0 positive nodes. TORS—radical tonsillectomy (2 cm in greatest dimension)
OO8 Outside excisional biopsy—7.5 cm node. Bilateral neck dissections—0 positive nodes. Left radical tonsillectomy—1.8 cm in greatest
dimension
OO9 Neck dissection—1 positive node, 4.2 cm in greatest dimension. TORS base of tongue resection—1.5 cm in greatest dimension
O1O Neck dissection—1 positive node, 4.5 cm in greatest dimension. TORS radical tonsillectomy (glossotonsillar sulcus—2.2 cm in greatest
dimension)

undergoing radical tonsillectomy had tumors with significant
soft palate or BOT involvement requiring extension of the
standardized approach.
For BOT tumors, the standardized approach was used as
per O'Malley et al.41 No tumors approached the midline. No
tumors extended deep into the glossotonsillar sulcus or
involved extrinsic tongue musculature. At least 1 cm gross
margins were included circumferentially. The deep margin
was established by first incising through intrinsic tongue
musculature in the midline until the epiglottis/vallecula were
encountered and then proceeding with the resection from
medial to lateral. Similar depth of resection was performed
for all patients in order to obtain an adequate deep margin.
3.2 | MBS DIGEST results
All 10 patients had the DIGEST safety scores of 0 at both
presurgery and 1-month postsurgery. DIGEST efficiency
scores were all 0 preoperative. At 1-month postsurgery, only
2 patients had a DIGEST efficiency score greater than 0, one
being scored “1” (10%-49% on all bolus types) and the other
scored “2” (50%-90% on solids only). Of these 2 patients,
both demonstrated reduced BOT motion. The patient with
the score of 2 demonstrated a unilateral pharyngeal weak-
ness, resulting in reduced bolus clearance through the phar-
ynx. Both of these patients had undergone radical
oropharyngectomy.
3.3 | Interjudge and intrajudge reliability
Interjudge reliability on measurements of DIGEST effi-
ciency and total scores was found to be substantial (kappa
statistics for efficiency: 0.76 (95% CI: 0.31, 1.00) and total
scores: 0.74 (95% CI: 0.26, 1.00).42 Inter-rater agreement
was 100% on DIGEST safety scores, as all scored 0 preoper-
atively and postoperatively. The rereview of scores
performed 2 weeks later by 2 raters reached 100% consensus
with their first scores.
3.4 | Performance status, tongue function, and
MDADI QOL
All patients were taking 100% nutrition orally and were tol-
erating a regular diet presurgery. Based on PSS scores on
the Normalcy of Diet subscale 1-month postsurgery, all
patients were taking a regular diet. Time to beginning oral
intake was 1 day for all patients. All patients had nasogastric
tubes placed for 2 days. Average length of stay was 2 days.
No patient underwent PEG or tracheostomy placement peri-
operatively or postoperatively. All patients at baseline scored
100 of 100 on the PSS Diet and Eating in Public subscale,
indicating that there were no restrictions in diet or eating in
public. At 1-month postsurgery, mean scores on the Eating
in Public were 97 (SD: 7.91) and Normalcy of Diet were
98 (SD: 4.22). There was a 2-point average decrease (95%
CI: −1.02, 5.02; P = .16) from pretreatment to 1-month
posttreatment in PSS diet, and 2.5-point decrease (95% CI:
−3.16, 8.15; P = .34) in PSS eating in public but neither
were significant reductions based on the estimates of linear
mixed models (Table 3). PSS Understandability of Speech
scores were 100 of 100 at both time points. Tongue range of
motion composite scores were 100 of 100 both presurgery
and postsurgery, indicating normal range of motion. MDADI
Composite, Global, Functional, Emotional, and Physical
scores were displayed in Table 4 and shown as not signifi-
cantly different from baseline to 1-month postsurgery in
Table 3.
4 | DISCUSSION
Patients undergoing TORS surgery in this study demon-
strated postsurgery scores comparable to those seen before
LAZARUS ET AL. 5

TABLE 3 Estimates of mean (SD) at presurgery and 1-month postsurgery and the average difference between the two time points in MDADI, tongue
composite scores, and PSS scores calculated by linear mixed models
Mean (SD)
Outcome variable Pre Post Average change (95% CI) P value
MDADI global score 92.67 (9.7) 91.11 (10.54) 1.56 (−9.89, 13.00) .76
MDADI composite score 92.56 (8.57) 85.67 (15.77) 6.89 (−6.79, 20.57) .27
MDADI emotional score 90.78 (7.74) 88.78 (14.55) 2.00 (−8.92, 12.92) .68
MDADI functional score 93.78 (8.51) 85.33 (17.55) 8.44 (−8.43, 25.32) .28
MDADI physical score 92.89 (14.63) 83.44 (16.72) 9.44 (−7.68, 26.56) .23
Tongue composite scores 100 (0) 100 (0) NE NE
PSS normalcy of diet 100 (0) 98 (4.22) 2 (−1.02, 5.02) .16
PSS understandability of speech 100 (0) 100 (0) NE NE
PSS eating in public 100 (0) 97.5 (7.91) 2.5 (−3.16, 8.15) .34

surgery for all PSS domains, indicating normal understand-
ability of speech, normal diet, and normal ability to eat in
public. In addition, tongue range of motion was normal for
all patients 1-month postsurgery, as seen on the Tongue
Composite Scores. Swallowing function as scored with the
DIGEST rating scale revealed normal safety and functional
efficiency within 1-month postsurgery. In addition, these
patients demonstrated high levels of patient-rated eating and
swallowing QOL based on the MDADI scale.
Treatment outcomes should not rely on patient-rated out-
comes alone, as subjective perceptions can differ dramati-
cally from objective findings, as shown by our data and that
of others.43–45 The DIGEST rating system is a reliable vali-
dated tool that is simple to score and can grade the degree of
pharyngeal phase swallow impairment based on safety and
efficiency components of the swallow. This scale offers a
5-point ordinal summary grade similar to that used in the
CTCAE, with fair agreement between the 2 scales.46 The
PSS is a reliable validated tool to assess the impact of treat-
ment on diet, ability to eat out, and speech understandability.
This objective tool has been employed to measure these out-
comes across head and neck tumor sites and treatments.47–50
In addition, the PSS has been used to examine other out-
comes, including depression, as well as for validation of
other PRO tools.50,51 Additionally, the MDADI is a very
useful and well-cited PRO tool. It has been translated and
validated in several languages. This dysphagia-specific
patient-rated questionnaire was designed to assess function
across head and neck sites and treatments.38Clinicians
should be cognizant of the potential discrepancy in percep-
tions of functioning as compared to objective outcomes
when counseling patients pretreatment regarding the pending
surgery.
Similar to our data, Owen and colleagues52 found preser-
vation of diet and QOL postsurgery as compared to baseline.
Leonhardt and colleagues25 found diet as obtained by the
PSS to be poorer at 6 months postsurgery compared to base-
line, with return to baseline by 12 months postsurgery. The
poorer diet outcomes at 6 months may be due to the fact that
some of their patients underwent adjuvant (chemo)radiother-
apy. PSS domains of poorer speech understandability and
ability to eat in public have also been observed in patients
with adjuvant treatment, with the poorest functioning occur-
ring in those with adjuvant chemoradiotherapy.25 Others29,31
found poorer QOL in patients undergoing adjuvant treatment
as compared to TORS surgery alone, with the poorest QOL
found with adjuvant chemoradiotherapy.53
Although others have reported the need for tracheostomy
and PEG tubes,26,53 no patient in our cohort required either,
although admittedly the size of our cohort is limited. In

TABLE 4 MDADI composite, global, emotional, functional and physical scores presurgery and 1-month postsurgery

MDADI MDADI MDADI MDADI MDADI MDADI MDADI MDADI MDADI MDADI
global global composite composite emotional emotional functional functional physical physical
Patient No score preop postop preop postop preop postop preop postop preop postop
OO1 100 80 95 80 87 93 96 76 100 73
OO2 100 100 94 80 93 80 84 80 100 80
OO3 94 80 96 53 87 60 100 48 100 50
OO4 no English no English no English no English no English no English no English no English no English no English
OO5 80 100 91 100 87 100 84 100 98 100
OO6 100 100 100 100 100 100 100 100 100 100
OO7 80 100 80 100 80 100 80 100 80 100
OO8 100 100 100 97 100 100 100 100 100 93
OO9 80 80 77 75 83 73 100 76 58 75
O1O 100 80 100 86 100 93 100 88 100 80
6 LAZARUS ET AL.
addition, only half the patients needed adjuvant radiotherapy.
Leonhardt and colleagues25 found a similar lack of impair-
ment in speech and swallow function in patients that did not
undergo adjuvant (chemo)radiotherapy. When comparing
patient-rated swallowing QOL in patients undergoing TORS
versus primary chemoradiotherapy, significant differences
have been found in QOL at 6 and 12 months posttreatment,
with better MDADI scores in patients treated with TORS sur-
gery.30 A recent study in healthy individuals examined prefer-
ence for radiotherapy versus TORS when provided a decision
aid.54 In this cohort of 40 healthy individuals, more than 80%
selected TORS for treatment.54 Clearly, patient preference
and satisfaction should be included in shared decision-making
discussions regarding treatment.
Although half of all patients in the cohort received adju-
vant radiotherapy, the goal of the study was to investigate
the functional impact of TORS alone, regardless of whether
patients underwent any additional treatment. The study was
designed to evaluate all patients at 1-month postsurgery, a
time point that was felt to both allow for adequate healing to
occur and that is typically prior to the administration of any
adjuvant therapy. Our data suggests that patients undergoing
TORS are functionally intact with near-baseline swallowing
function before any potential adjuvant therapy is given.
As noted above, a significant limitation of this study was
the small number of patients in this cohort. We note that sta-
tistical analysis to evaluate effects in small cohorts is subject
to a variety of errors including selection bias, sampling errors,
insufficient power, and so forth, and we view this as prelimi-
nary data, which indicate that in properly selected patients,
minimally invasive transoral surgery has minimal impact on
functional and QOL metrics. We acknowledge that this study
is underpowered and that significant differences between pre-
operative and postoperative PRO measures might have been
observed with a larger cohort of patients. We are continuing
to collect prospective data on our patients undergoing TORS
for oropharyngeal cancers in order to obtain sufficient power
for more robust analysis. We also are currently following our
patients’ further post-TORS surgery to examine the long-term
functional effects of TORS.
5 | CON CLU SION S
This is the first study to examine swallowing function pre-
TORS and post-TORS surgery using an instrumental assess-
ment of swallowing, the MBS procedure, along with a
reliable and validated measure, the DIGEST scale. All
patients were able to take a regular diet postsurgery and
reported being able to eat in public. They also demonstrate
normal speech understandability and normal tongue ROM.
DIGEST scores were not significantly different from presur-
gery to postsurgery, with a mean DIGEST overall grade of
0.2, indicating a safe and efficient oropharyngeal swallow.
Five patients needed adjuvant radiotherapy in this study and
none needed adjuvant chemotherapy. Careful identification
of appropriate patients can result in excellent tongue func-
tion, speech and swallow outcomes, with fewer patients
needing adjuvant treatment. Future studies will examine lon-
ger follow-up of speech, swallowing, and tongue function in
patients undergoing TORS surgery.
ACKNOWLEDGMENTS
The authors wish to acknowledge the support of the Biosta-
tistics Shared Resource Facility, Icahn School of Medicine
at Mount Sinai, and NCI Cancer Center Support Grant P30
CA196521-01.
CONFLICT OF IN TER EST
None.
OR CID
Cathy L. Lazarus https://orcid.org/0000-0003-1046-4127
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How to cite this article: Lazarus CL, Ganz C,
Ru M, Miles BA, Kotz T, Chai RL. Prospective
instrumental evaluation of swallowing, tongue func-
tion, and QOL measures following transoral robotic
surgery alone without adjuvant therapy. Head &
Neck. 2018;1–7. https://doi.org/10.1002/hed.25455