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CompletedNCT00205543Updated Jun 21, 2012

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

An interventional study of uvulopalatopharyngoplasty with or without sutures in Obstructive Sleep Apnea, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2012-06-21.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • obstructive sleep apnea
  • airway obstruction
  • sleep-disordered breathing
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 16 is below the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • previous palate surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    1

    suture palate after resection

    Procedure: uvulopalatopharyngoplasty with or without sutures

  • Experimental
    2

    suture one side of palate afer resection

    Procedure: uvulopalatopharyngoplasty with or without sutures

  • Experimental
    3

    no sutures in palate after resection

    Procedure: uvulopalatopharyngoplasty with or without sutures

Interventions

  • Procedureuvulopalatopharyngoplasty with or without sutures

    standard UPPP

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6-12mo

Secondary outcomes

  1. Operative time

    Time frame: immediate

  2. Procedure cost

    Time frame: immediate

07

Study locations

1 site
  • Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University
    Richmond, Virginia 23298-0146, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00205543
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
Jul 2004
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Jun 21, 2012

Study contacts

Evan R Reiter, MD
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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