Study of Effects of Sutures on Results of Palate Surgery for Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
uvulopalatopharyngoplasty with or without sutures
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, airway obstruction, sleep-disordered breathing
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
Sites / Locations
- Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
suture palate after resection
suture one side of palate afer resection
no sutures in palate after resection
Outcomes
Primary Outcome Measures
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 Outcome Measures
Operative time
Procedure cost
Full Information
NCT ID
NCT00205543
First Posted
September 15, 2005
Last Updated
June 19, 2012
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT00205543
Brief Title
Study of Effects of Sutures on Results of Palate Surgery for Obstructive Sleep Apnea
Official Title
Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, airway obstruction, sleep-disordered breathing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
suture palate after resection
Arm Title
2
Arm Type
Experimental
Arm Description
suture one side of palate afer resection
Arm Title
3
Arm Type
Experimental
Arm Description
no sutures in palate after resection
Intervention Type
Procedure
Intervention Name(s)
uvulopalatopharyngoplasty with or without sutures
Intervention Description
standard UPPP
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Operative time
Time Frame
immediate
Title
Procedure cost
Time Frame
immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan R Reiter, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0146
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Effects of Sutures on Results of Palate Surgery for Obstructive Sleep Apnea
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