- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00205543
Study of Effects of Sutures on Results of Palate Surgery for Obstructive Sleep Apnea
June 19, 2012 updated by: Virginia Commonwealth University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298-0146
- Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
suture palate after resection
|
standard UPPP
|
Experimental: 2
suture one side of palate afer resection
|
standard UPPP
|
Experimental: 3
no sutures in palate after resection
|
standard UPPP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6-12mo
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Operative time
Time Frame: immediate
|
immediate
|
Procedure cost
Time Frame: immediate
|
immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Evan R Reiter, MD, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 15, 2005
First Submitted That Met QC Criteria
September 15, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
June 21, 2012
Last Update Submitted That Met QC Criteria
June 19, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03802
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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