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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Procedure: uvulopalatopharyngoplasty with or without sutures

• Registration Number: NCT00205543
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-20
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	uvulopalatopharyngoplasty with or without sutures	suture palate after resection
2	uvulopalatopharyngoplasty with or without sutures	suture one side of palate afer resection
3	uvulopalatopharyngoplasty with or without sutures	no sutures in palate after resection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Operative time	immediate
Procedure cost	immediate

Trial Locations

Locations (1)

Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States