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

Obstructive Sleep Apnea Clinical Trial

Official title:

Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205543
• Other study ID #: 03802
• Status: Completed
• Phase: N/A
• First received: September 15, 2005
• Last updated: June 19, 2012
• Start date: July 2004
• Est. completion date: December 2008

Study information

• Verified date: June 2012
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• uvulopalatopharyngoplasty with or without sutures
standard UPPP

Locations

Country	Name	City	State
United States	Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Operative time		immediate	No
Secondary	Procedure cost		immediate	No