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

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ClinicalTrials.gov Identifier: NCT00205543
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : June 21, 2012
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Procedure: uvulopalatopharyngoplasty with or without sutures Not Applicable

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  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes
Study Start Date : July 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: 1
suture palate after resection
Procedure: uvulopalatopharyngoplasty with or without sutures
standard UPPP

Experimental: 2
suture one side of palate afer resection
Procedure: uvulopalatopharyngoplasty with or without sutures
standard UPPP

Experimental: 3
no sutures in palate after resection
Procedure: uvulopalatopharyngoplasty with or without sutures
standard UPPP




Primary Outcome Measures :
  1. 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 Measures :
  1. Operative time [ Time Frame: immediate ]
  2. Procedure cost [ Time Frame: immediate ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00205543     History of Changes
Other Study ID Numbers: 03802
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Virginia Commonwealth University:
obstructive sleep apnea
airway obstruction
sleep-disordered breathing

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases