Prospective Study to Evaluate Outcomes From Transoral Base of Tongue Resection for Obstructive Sleep Apnea Hypopnea Syndrome
Conditions: Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
Sponsor: University of Alabama at Birmingham

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Prospective Study to Evaluate Outcomes from Trans-oral Base of Tongue Resection 
for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) 
 
 
NCT 01107795 
 
 
 
Coordinating Center: 
Division of Otolaryngology – Head and Neck Surgery 
 
 
 
 
University of Alabama at Birmingham 
 
 
Principal Investigator: 
Kirk Withrow, MD 
Assistant Professor of Surgery 
Division of Otolaryngology – Head and Neck Surgery 
563 Boshell Building 
1808 17th Avenue South 
Phone: 205-934-9765 
Fax: 205-934-3993 
Email: kirk.withrow@ccc.uab.edu  
 
 
Sub-Investigators: 
 
Scott Magnuson, MD 
 
 
 
 
William Carroll, MD 
 
 
Research Coordinator:  
 Lisa Clemons, MSN, RN, OCN 
 
 Phone: 205-934-9714 
 
 Email: lclemons@uab.edu 
 
 

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INDEX 
 
 
 
1. 
Study Schema 
2. 
Summary 
3. 
Background and Rationale 
4. 
Study Objectives 
5. 
Trial Design 
6. 
Patient Selection Process 
7. 
Registration Process 
8. 
Study Treatment 
9. 
Adverse Reaction Reporting 
10. 
Subject Evaluations 
11. 
References 
 
 
 
 
 
 
 
 
 
 

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1.0 STUDY SCHEMA 
 
 
 
 
 
 
 
 
 
 
 
 
 
           ↓ 
 
 
 
 
 
 
 
 
 
↓ 
 
 
 
 
↓ 
 
 
 
 
 
 
↓ 
 
 
 
 
 
 
 
 
 
 
 
Informed 
consent obtained 
Patient enrolled 
into study 
Surgery 
Patient Follow-up 
1. Post Op pain diary 
2. First post-operative 
visit. 
3. Routine 3-month 
follow-up.  
Patients with obstructive sleep apnea 
hypopnea syndrome (OSAHS) who 
are candidates for base of tongue 
(BOT) resection. 

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2.0 SUMMARY 
 
This is a prospective observational study that will collect outcome data for patients who 
choose to undergo transoral robotic assisted tongue base operations for Obstructive Sleep 
Apnea Hypopnea Syndrome (OSAHS). The da Vinci® Robotic Surgical System 
(Intuitive Surgical) is the system used at the University of Alabama at Birmingham 
(UAB) and will be utilized for this study. 
 
3.0 BACKGROUND AND RATIONALE 
 
Obstructive sleep apnea hypopnea syndrome (OSAHS) is a major public health problem, 
and studies suggest that the incidence of OSAHS may be even higher than estimated. 
Transoral base of tongue resections are commonly preformed to improve symptoms in 
OSAHS, but among surgeons there is not yet consensus as to the best tongue base 
operation. The difficulty in treating the tongue base is illustrated by the abundance of 
available procedures – including genioglossus advancement, hyoid advancement, tongue 
base suspension, radiofrequency treatment, transoral midline glossesctomy, submucosal 
coblation-assisted tongue base resection and recently; transoral robotic-assisted surgery 
(TORS) for base of tongue (BOT) resection. We will evaluate TORS BOT resection for 
use in OSAHS by assessing pre- and post-operative OSAHS scores and comparing them 
to historical data for alternative BOT operations. 
 
Though routine, BOT resection may result in significant post-operative pain leading to 
dysphagia. In certain patients, major complications such as aspiration pneumonia, 
malnutrition and dehydration can occur as a result. Thus, reducing post-operative 
dysphagia is critical to improving patient outcomes and limiting complication-associated 
hospital admissions. Several studies have addressed the management of post-operative 
dysphagia, but none have evaluated TORS BOT resections in OSAHS. Additionally, 
TORS BOT resections for malignant neoplasms have been previously shown by Dr. 
Magnuson and Dr. Carroll to be safe and feasible. An outcome analysis of TORS BOT 
resections for OSAHS may therefore yield recommendations for reducing patient 
morbidity and mortality.  
To evaluate TORS BOT resection as a treatment for OSAHS; patients will serve as their 
own controls by undergoing assessment for OSAHS pre- and post-operatively. We will 
characterize patient morbidities associated with surgical correction of OSAHS by 
reviewing data collected during regularly scheduled follow-up visits (Appendix A), and 
by patient pain diaries (Apendix B). In addition, we will independently assess dysphagia 
using the M.D. Anderson Dysphagia Inventory (Appendix C). Our goal is to improve 
quality of life for future OSAHS patients undergoing BOT resection. 
 
While previous publications have documented the use of robotic assisted oropharyngeal 
surgery, the transoral approach is considered off-label use of robotic assisted surgery. 
Currently the transoral approach is being performed at UAB for oropharynx surgery 
(HNO 0601).  Therefore, we are proposing to perform a series of tongue base resections 

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in 40 patients to assess this technique at the University of Alabama at Birmingham.  The 
Division of Otolaryngology sees many OSAHS patients a year that would be candidates 
for operative intervention using the robotic assisted surgery.  A robotic surgical system is 
available for this purpose and is currently used by multiple specialties at the University 
Hospital. 
 
4.0 OBJECTIVES: 
 
4.1 Primary Objective:  
 
The primary objective of this study will be to determine if base of tongue (BOT) 
resection with transoral robotic-assisted surgery (TORS) yields improvements in 
OSAHS with reduction in apnea/hypopnea index. 
 
 
5.0 TRIAL DESIGN  
 
This trial is a single institution non-randomized study to evaluate the efficacy and safety 
of transoral robotic-assisted surgery (TORS).  We propose to use the da Vinci ® Robotic 
Surgical System which is currently in place at UAB to perform surgical resection in 40 
patients with OSAHS. 
 
Patients with OSAHS, who present to the Division of Otolaryngology and are scheduled 
for base of tongue surgery and enrolled to this study, will be given a pain diary to start 
the morning of surgery to continue for a total of two weeks following surgery. Patients 
will also be asked to complete the MD Anderson Dysphagia Index (MDADI) swallowing 
questionnaire to be done prior to surgery, at their post operative clinic visit and at 
approximately three months following surgery. A sleep study will be done two to three 
months following surgery if allowed by participant’s insurance carrier. A medical record 
review will be done on all participants who complete the diary and questionnaire.  
 
6.0 PATIENT SELECTION CRITERIA 
 
6.1 Eligibility Criteria  
 
1. Any patient with documented OSAHS who is scheduled for tongue base 
resection at UAB. 
2. Age > 19 years 
3. Patients must sign informed consent 
 
 
 
 
 
6.2 Exclusion Criteria 
 

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1. Psychological condition that renders the patient unable to understand the 
informed consent.  
2. Any situation or condition that will interfere with adherence to study 
activities. 
 
 
7.0 REGISTRATION  
 
Patients must not start protocol treatment prior to formal registration and informed 
consent. 
 
7.1 Patient Consent 
Patients thought to be candidates for this protocol will be identified by 
his/her physician.  The study will be explained to the patient and a consent 
form will be given for review. 
 
7.2 Patient Screening 
Patients who agree to participate in the study and have signed informed 
consent will undergo patient screening.   
 
7.3 Patient Registration  
Patients, who have signed the informed consent and meet the eligibility 
criteria, will be entered into the study prior to any protocol therapy. The 
following information will be required at the time of patient entry:  
 
-  Patient's name (or initials) and ID #, hospital chart number  
 
-  Verifying Physician's Name 
 
-  Eligibility Criteria Information  
-  Demographic Data (sex, birth, date, race, nine-digit zip code, and 
method of payment) 
 
8.0 STUDY TREATMENT 
 
Robotic assisted surgery will be performed in standard fashion. If at any point during the 
procedure the area for resection is not well visualized, or the resection is compromised, or 
the procedure is felt to be unsafe (for example potential injury to teeth or gums), the 
procedure will be aborted. Participants will then be presented an alternative treatment 
plan for this condition.  
 
 
Post-operative care and discharge will be performed in the routine manner for OSAHS. 
Medical records will be reviewed from this period of routine care to determine what 
effects, good and/or bad, this procedure has on the patient. These records will include 
hospital and clinic records such as clinic and hospital notes, anesthesia notes, 
radiological imaging and speech pathology information.  Patients will be followed post-
operatively using standard practice.   
 
 

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9.0 ADVERSE EVENT REPORTING 
 
9.1 Potential treatment hazards 
 
9.1.1 Injury to perioral structures during the surgical procedure.  Use of 
the robot in transoral surgery has been demonstrated to be safe in a limited 
data set.  However, the use of oral instrumentation for access to base of 
tongue resections can result in injury to teeth, gums and/or the tongue. The 
standard risks of surgery include post operative pain and discomfort, 
bleeding, infection, post operative pneumonia, laryngeal and pharyngeal 
swelling, difficulty in swallowing, injury to nerves and blood vessels 
failure to perform resection and adverse reactions or complications from 
anesthesia. Although very rare, with any surgery there is a risk of life 
threatening events that may result in persistent or significant 
disability/incapacity or death. In some cases, a feeding tube may be placed 
to ensure adequate nutrition and fluid intake. On rare occasions, severe 
throat edema may require prolonged intubation or re-intubation. There is 
also a rare risk for instrument breakage and power outage resulting in a 
shutdown of transoral diagnostic and therapeutic surgical equipment. UAB 
has backup precautions for these types of situations. It is felt that the use 
of the robotic assisted surgery will not add additional risks to the standard 
surgical risks.   
 
9.1.2 Need for additional surgery in cases where TORS cannot be 
adequately performed. 
 
9.1.4 Confidentiality:  As a participant in a UAB protocol that collects 
data on patients including personal information and disease related 
information, there is a potential for breach of patient confidentially. 
 
9.2 Reporting adverse events 
 
 
9.2.1  Expedited reporting methods 
Unexpected or serious adverse events (SAE) are to be reported 
immediately to Dr. Kirk Withrow (205) 934-9765; UAB Paging 
Operator (205) 934-3411. The SAE reporting period begins with 
signing of the informed consent. Any event that is both serious and 
unexpected must be reported to UAB’s Institutional Review Board 
for Human Use within 24 hours after the investigator’s initial 
receipt of the information. A written report must follow in 10 
working days of the report. 
9.2.2 Adverse event reporting definitions 
In the event of an adverse event the first concern will be for the 
safety of the subject. Serious adverse events to be reported is 

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defined as any sign, symptom or medical condition that emerges 
during surgery through a period of 30 days following surgery that 
(1) was not present prior to surgery and is not a chronic condition 
that is in the patient’s medical history OR (2) was presented prior 
to surgery but worsened as a result of surgery, AND that meets any 
of the following regulatory serious criteria: 
 
 Results in death 
 Is life-threatening 
 Requires or prolongs inpatient hospitalization 
 Is disabling 
 Is a congenital anomaly/birth defect 
 Is medically significant or requires medical or 
surgical intervention to prevent one of the outcomes 
listed above. 
 
9.2.3 Adverse event that does not require expedited reporting 
Any hospitalization for needed additional surgery or additional 
treatment of the disease for OSAHS or supportive care for disease 
that is unrelated to surgery such a PEG tube placement does not 
require expedited reporting.  
 
9.2.4 Safety Monitoring 
 
 Dr. Kirk Withrow will be responsible for review of 
the data. If at any time it is determined that the risks 
of participation outweigh the benefits, the study will 
be reviewed by Dr. Withrow and the research staff.  
 Participant information and adverse events will be 
evaluated as deemed necessary at the meetings of 
the Office of Clinical Research for the UAB 
Division of Otolaryngology – Head and Neck 
Surgery. 
 All events determined to be Serious Adverse 
Events, whether related to the study procedure or 
not, will be reported to the Institutional Review 
Board at UAB.  
 
 
 
10.0 SUBJECT EVALUATIONS 
 
 
10.1 Baseline evaluations: 
1. Routine medical exam prior to surgery. 
 
 
2. Dysphagia survey prior to surgery. 
                        3. OSAHS evaluation 

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10.2 Pain Diary to be completed by participant daily starting with the day of  
        surgery through 2 weeks post op. 
 
 
 
10.3 Routine follow up exams for three months: (post operative exam and three  
                    month follow up exam) 
 
1. Routine medical exam. 
 
2. Assessment for adverse events. 
 
3. Dysphagia survey. 
 
4. OSAHS evaluation (including sleep study if allowed by participant’s  
     insurance). 
 
 
11.0 REFERENCES:  
 
1. Boudreaux BA, Rosenthal EL, Magnuson JS, Newman JR, Desmond RA, 
Clemons L, Carroll WR. Robot-assisted surgery for upper aerodigestive tract 
neoplasms. Arch Otolaryngology Head Neck Surg 2009 Apr; 135 (4):397-
401. 
2. Iseli TA, Kulbresh BD, Iseli CE, Carroll WR, Rosenthal EL, Magnuson JS. 
Functional outcomes after transoral robotic surgery for head and neck cancer. 
Otolaryngol Head Neck Surg 2009 Aug; 141(2):166-71