|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| 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 | ||||
| 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. |
||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| 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 ] | ||||
| Secondary Outcome Measure † | Operative time [ Time Frame: immediate ] [ Designated as safety issue: No ] Procedure cost [ Time Frame: immediate ] [ Designated as safety issue: No ] |
||||
| Condition † | Obstructive Sleep Apnea | ||||
| Intervention † | Procedure: uvulopalatopharyngoplasty with or without sutures | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 30 | ||||
| Start Date † | July 2004 | ||||
| Completion Date | December 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00205543 | ||||
| Organization ID | 03802 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Virginia Commonwealth University | ||||
| Collaborators †† | |||||
| Investigators † |
|
||||
| Information Provided By | Virginia Commonwealth University | ||||
| Verification Date | July 2008 | ||||
| First Received Date † | September 15, 2005 | ||||
| Last Updated Date | July 9, 2008 | ||||