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

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 with or without sutures

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel 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 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 [ Time Frame: 6-12mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Operative time [ Time Frame: immediate ] [ Designated as safety issue: No ]
Procedure cost [ Time Frame: immediate ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	July 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental suture palate after resection	Procedure: uvulopalatopharyngoplasty with or without sutures standard UPPP
2: Experimental suture one side of palate afer resection	Procedure: uvulopalatopharyngoplasty with or without sutures standard UPPP
3: Experimental no sutures in palate after resection	Procedure: uvulopalatopharyngoplasty with or without sutures standard UPPP

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205543

Locations

United States, Virginia
Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0146

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

Principal Investigator:

Evan R Reiter, MD

Virginia Commonwealth University

More Information

Responsible Party:	Virginia Commonwealth University ( Evan R. Reiter, MD )
Study ID Numbers:	03802
Study First Received:	September 15, 2005
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00205543
Health Authority:	United States: Food and Drug Administration

Keywords provided by Virginia Commonwealth University:

obstructive sleep apnea
airway obstruction
sleep-disordered breathing

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Apnea, Obstructive

Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Airway Obstruction
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009