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

This study is currently recruiting patients

Verified by Virginia Commonwealth University September 2006

Sponsored by: Virginia Commonwealth University
Information provided by: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00205543


Purpose

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 Intervention
Obstructive Sleep Apnea Procedure: uvulopalatopharyngoplasty

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title: Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes

Further study details as provided by Virginia Commonwealth University:
Primary Outcomes: 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
Secondary Outcomes: Operative time; Procedure cost
Expected Total Enrollment:  30

Study start: July 2004;  Expected completion: January 2008
Last follow-up: August 2007;  Data entry closure: August 2007

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.

Eligibility

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00205543

Evan R Reiter, MD      804-828-2766    erreiter@vcu.edu

Virginia
Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University, Richmond,  Virginia,  23298-0146,  United States; Recruiting
Evan R Reiter, MD  804-828-2766    erreiter@vcu.edu 
Evan R Reiter, MD,  Principal Investigator

Study chairs or principal investigators

Evan R Reiter, MD,  Principal Investigator,  Virginia Commonwealth University   

More Information

Study ID Numbers:  03802
Last Updated:  September 7, 2006
Record first received:  September 15, 2005
ClinicalTrials.gov Identifier:  NCT00205543
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-10-02





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