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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Completed

CT.gov ID

NCT00205543

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Procedure: uvulopalatopharyngoplasty with or without sutures	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes

Study Start Date :

Jul 1, 2004

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 suture palate after resection	Procedure: uvulopalatopharyngoplasty with or without sutures standard UPPP
Experimental: 2 suture one side of palate afer resection	Procedure: uvulopalatopharyngoplasty with or without sutures standard UPPP
Experimental: 3 no sutures in palate after resection	Procedure: uvulopalatopharyngoplasty with or without sutures standard UPPP

Arm

Intervention/Treatment

Experimental: 1

suture palate after resection

Procedure: uvulopalatopharyngoplasty with or without sutures

standard UPPP

Experimental: 2

suture one side of palate afer resection

Procedure: uvulopalatopharyngoplasty with or without sutures

standard UPPP

Experimental: 3

no sutures in palate after resection

Procedure: uvulopalatopharyngoplasty with or without sutures

standard UPPP

Outcome Measures

Primary Outcome Measures

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

Operative time [immediate]
Procedure cost [immediate]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

sleep-study documented obstructive sleep apnea
sleep apnea refractory to non-surgical treatments including continuous positive airway pressure (CPAP)
age > 21