Clinical trial NCT01107795: Prospective Study to Evaluate Outcomes From Transoral BOT Resection for OSAHS
Official title: Prospective Study to Evaluate Outcomes From Transoral Base of Tongue Resection for Obstructive Sleep Apnea Hypopnea Syndrome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2010-04-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who choose to undergo transoral robotic assisted tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS).

Brief summary: This is a prospective observational study that will collect outcome data for patients who choose to undergo transoral tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)as part of their standard of care treatment. This is a data collection study only and does not provide for evaluations or treatment of OSAHS.

Detailed description: 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 shownto be safe and feasible. An outcome analysis of TORS BOT resections for OSAHS may therefore yield recommendations for reducing patient morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

1. Any patient with documented OSAHS who is scheduled for tongue base resection at UAB
2. Age \> 18
3. Patients must sign informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Improvement in Apnea Hypopnea Index (AHI) Score
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kirk Withrow, MD
role: PRINCIPAL_INVESTIGATOR
References: