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

Tracking Information

First Received Date ^ICMJE

September 15, 2005

Last Updated Date

July 9, 2008

Start Date ^ICMJE

July 2004

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00205543 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Operative time
Procedure cost

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obstructive Sleep Apnea

Intervention ^ICMJE

Procedure: uvulopalatopharyngoplasty with or without sutures

Study Arms / Comparison Groups

Experimental: suture palate after resection
Experimental: suture one side of palate afer resection
Experimental: no sutures in palate after resection

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2008

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00205543

Responsible Party

Evan R. Reiter, MD, Virginia Commonwealth University

Study ID Numbers ^ICMJE

03802

Study Sponsor ^ICMJE

Virginia Commonwealth University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Evan R Reiter, MD

Virginia Commonwealth University

Information Provided By

Virginia Commonwealth University

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP