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

NCT ID: NCT00205543

Last Updated: 2012-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2008-12-31

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

suture palate after resection

Group Type: EXPERIMENTAL

uvulopalatopharyngoplasty with or without sutures

Intervention Type: PROCEDURE

standard UPPP

2

suture one side of palate afer resection

Group Type: EXPERIMENTAL

uvulopalatopharyngoplasty with or without sutures

Intervention Type: PROCEDURE

standard UPPP

3

no sutures in palate after resection

Group Type: EXPERIMENTAL

uvulopalatopharyngoplasty with or without sutures

Intervention Type: PROCEDURE

standard UPPP

Interventions

uvulopalatopharyngoplasty with or without sutures

standard UPPP

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evan R Reiter, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

03802

Identifier Type: -

Identifier Source: org_study_id