Vessel Sealing System Uvulopalatoplasty Versus Uvulopalatal Flap

Not Applicable

• Conditions: Snoring; Obstructive Sleep Apnea

• Registration Number: NCT00806637
• Lead Sponsor: Chulalongkorn University

Brief Summary

The purpose of this study is to compare vessel sealing system uvulopalatoplasty (VSSU) to the traditional uvulopalatal flap (UPF) in the treatment of sleep-disordered breathing with special regard to intraoperative bleeding, operative time, postoperative pain, postoperative hemorrhage and other adverse effects.

Detailed Description

Uvulopalatopharyngoplasty is one of the common procedures performed by otolaryngologists to treat sleep-disordered breathing patients who have retropalatal obstruction. Intraoperative bleeding is a significant problem which requires hemostasis and causes prolonged operative time. Several different techniques are used to perform this operation, including cold knife, monopolar cautery, coblation, and radiofrequency. Efficacy in hemostasis and tissue trauma from different operative techniques may result in different operative time and different degrees of morbidity including intraoperative blood loss, postoperative pain, postoperative hemorrhage, and velopharyngeal insufficiency (VPI). The vessel sealing system has been widely used in head and neck surgery because of its effectiveness and safety. It was also found quite effective and safe in tonsillectomy procedures, providing excellent hemostasis and minimal tissue trauma.

Study Timeline

• Status Verified: 2008-10
• Study Start: 2008-10
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Last Update Submitted: 2008-12-10
• Study First Posted: 2008-12-11
• Last Update Posted: 2008-12-11
• Primary Completion: 2009-05
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient planned for uvulopalatoplasty for indications of snoring or obstructive sleep apnea
• Written informed consent form is given from patient

Exclusion Criteria

• Pregnancy
• History of bleeding disorders
• Patient unable to understand evaluation method
• Patient unable to be contacted via telephone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
intraoperative blood loss	within the first 1 hour after surgery starting time

Secondary Outcome Measures

Name	Time	Method
postoperative pain	within the first 14 days after surgery
postoperative bleeding	within the first 14 days after surgery
operative time	within the first 1 hour after surgery starting time
postoperative velopharyngeal insufficiency	within the first 3 months after surgery

Trial Locations

Locations (1)

Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University; 🇹🇭 Patumwan, Bangkok, Thailand

Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University

🇹🇭Patumwan, Bangkok, Thailand