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:
Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00205543
VirginiaDepartment 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:
NCT00205543Health Authority: United States: Food and Drug Administration ClinicalTrials.gov processed this record on 2006-10-02 |
