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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00205543
First received: September 15, 2005
Last updated: June 19, 2012
Last verified: June 2012

September 15, 2005
June 19, 2012
July 2004
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT00205543 on ClinicalTrials.gov Archive Site
  • Operative time [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Procedure cost [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Operative time
  • Procedure cost
Not Provided
Not Provided
 
Study of Effects of Sutures on Results of Palate Surgery for Obstructive Sleep Apnea
Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea
Procedure: uvulopalatopharyngoplasty with or without sutures
standard UPPP
  • Experimental: 1
    suture palate after resection
    Intervention: Procedure: uvulopalatopharyngoplasty with or without sutures
  • Experimental: 2
    suture one side of palate afer resection
    Intervention: Procedure: uvulopalatopharyngoplasty with or without sutures
  • Experimental: 3
    no sutures in palate after resection
    Intervention: Procedure: uvulopalatopharyngoplasty with or without sutures
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205543
03802
No
Virginia Commonwealth University
Virginia Commonwealth University
Not Provided
Principal Investigator: Evan R Reiter, MD Virginia Commonwealth University
Virginia Commonwealth University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP