Study of Effects of Sutures on Results of Palate Surgery for Obstructive Sleep Apnea

Study Overview
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Brief Summary
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In this study we will examine whether suture repair of the palate, or roof of mouth, has any effect on results of palate surgery performed for treatment of obstructive sleep apnea.

Detailed Description
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Uvulopalatopharyngoplasty, or UPPP, is the most common surgical procedure performed for the treatment of obstructive sleep apnea. The procedure involves removal of redundant tissue from the lower palate (roof of mouth), including the uvula, and then suturing the cut edges of the remaining tissue together. However it is frequently noted by surgeons that sutures placed in the roof of the mouth do not stay intact. Also, in standard tonsillectomy, which involves removal of the tonsils and thus creation of a wound near the palate, no suturing is used, which does not seem to affect how the area heals. Previous studies have shown no significant differences in complication rates, post-operative pain, or symptom outcomes in patients undergoing tonsillectomy either with or without suture repair of the tonsillectomy wound. In this study we will examine whether suture repair following UPPP has any effect on post-operative pain, healing, or treatment success in terms of symptom resolution or post-operative sleep study results.

Official Title
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Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Procedure: uvulopalatopharyngoplasty with or without sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sleep-study documented obstructive sleep apnea sleep apnea refractory to non-surgical treatments including continuous positive airway pressure (CPAP) age > 21 Exclusion Criteria: previous palate surgery

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>suture palate after resection | Procedure: uvulopalatopharyngoplasty with or without sutures<br>* standard UPPP<br>|
| Experimental: 2<br>suture one side of palate afer resection | Procedure: uvulopalatopharyngoplasty with or without sutures<br>* standard UPPP<br>|
| Experimental: 3<br>no sutures in palate after resection | Procedure: uvulopalatopharyngoplasty with or without sutures<br>* standard UPPP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep study result at 3-6 months; symptom changes at 3-6 months; pain at 0-3 weeks; post-operative complications at any time; post-operative anatomic result/appearance at 3-6 months |  | 6-12mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | immediate | 
| Procedure cost |  | immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, airway obstruction, sleep-disordered breathing