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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Procedure: uvulopalatopharyngoplasty with or without sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT00205543

03802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Exclusion criteria

• previous palate surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

1

Experimental group

Description:

suture palate after resection

Treatment:

Procedure: uvulopalatopharyngoplasty with or without sutures

2

Experimental group

Description:

suture one side of palate afer resection

Treatment:

Procedure: uvulopalatopharyngoplasty with or without sutures

3

Experimental group

Description:

no sutures in palate after resection

Treatment:

Procedure: uvulopalatopharyngoplasty with or without sutures