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

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

This study is ongoing, but not recruiting participants.
Information provided by Virginia Commonwealth University

This Tabular View shows the required WHO registration data elements as marked by ^†

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 ^†

Start Date ^†

July 2004

Completion Date

December 2008

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00205543

Organization ID

03802

Secondary IDs ^††

Study Sponsor ^†

Virginia Commonwealth University

Collaborators ^††

Investigators ^†

Principal Investigator:

Evan R Reiter, MD

Virginia Commonwealth University

Information Provided By

Virginia Commonwealth University

Verification Date

July 2008

First Received Date ^†

September 15, 2005

Last Updated Date

July 9, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.