Vessel Sealing System Uvulopalatoplasty Versus Uvulopalatal Flap

Vessel Sealing System Uvulopalatoplasty vs Uvulopalatal Flap: a Randomized, Control Study of Efficacy and Adverse Effects

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.

Study Overview

• Status: Unknown
• Conditions: Snoring; Obstructive Sleep Apnea
• Intervention / Treatment: Procedure: Vessel sealing system uvulopalatoplasty (VSSU); Procedure: Uvulopalatal flap (UPF)

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Patumwan, Bangkok, Thailand, 10330
      • Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Vessel sealing system uvulopalatoplasty (VSSU) is a new technique for uvulopalatoplasty using a special biclamp forceps for better hemostasis control. Vessel sealing system (VSS) is a bipolar vascular sealing system, with integrated active feedback control. The tissue is grasped and compressed by the handpiece. After the instrument is removed, the seal is visible as a semitransparent window, which can safely be divided. Uvular tip is grasped with an Allis clamp and retracted back toward the soft palate. Excision of the uvula and the redundant part of soft palate is performed by the VSS handpiece. VSS is also used for hemostasis.	Procedure: Vessel sealing system uvulopalatoplasty (VSSU); Vessel sealing system uvulopalatoplasty (VSSU) is a new technique for uvulopalatoplasty using a special biclamp forceps for better hemostasis control. Vessel sealing system (VSS) is a bipolar vascular sealing system, with integrated active feedback control. The tissue is grasped and compressed by the handpiece. After the instrument is removed, the seal is visible as a semitransparent window, which can safely be divided. Uvular tip is grasped with an Allis clamp and retracted back toward the soft palate. Excision of the uvula and the redundant part of soft palate is performed by the VSS handpiece. VSS is also used for hemostasis.; Other Names: ligasure vessel sealing system
Active Comparator: 2; Uvulopalatal flap (UPF) is a standard uvulopalatoplasty technique. Uvulopalatal flap is usually performed as described originally by Powell et al. The soft palate was injected with 5 to 10 milliliters of 1% lidocaine with epinephrine solution. The mucosa, submucosa with glands, and fat on the lingual surface of the uvula and soft palate were removed with a scalpel. Bleeding was controlled with bipolar electrocoagulation. The uvular tip was amputated, and reflected back toward the soft palate, and fixated into its new position with multiple sutures of 3-0 chromic catgut.	Procedure: Uvulopalatal flap (UPF); Uvulopalatal flap (UPF) is a standard uvulopalatoplasty technique. Uvulopalatal flap is usually performed as described originally by Powell et al. The soft palate was injected with 5 to 10 milliliters of 1% lidocaine with epinephrine solution. The mucosa, submucosa with glands, and fat on the lingual surface of the uvula and soft palate were removed with a scalpel. Bleeding was controlled with bipolar electrocoagulation. The uvular tip was amputated, and reflected back toward the soft palate, and fixated into its new position with multiple sutures of 3-0 chromic catgut.; Other Names: uvulopalatoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
intraoperative blood loss	within the first 1 hour after surgery starting time

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Prakobkiat Hirunwiwatkul, M.D., Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University

Publications and helpful links

General Publications

• Lachanas VA, Hajiioannou JK, Karatzias GT, Filios D, Koutsias S, Mourgelas C. Comparison of LigaSure vessel sealing system, harmonic scalpel, and cold knife tonsillectomy. Otolaryngol Head Neck Surg. 2007 Sep;137(3):385-9. doi: 10.1016/j.otohns.2007.05.012.
• Powell N, Riley R, Guilleminault C, Troell R. A reversible uvulopalatal flap for snoring and sleep apnea syndrome. Sleep. 1996 Sep;19(7):593-9. doi: 10.1093/sleep/19.7.593.
• Prokopakis EP, Lachanas VA, Helidonis ES, Velegrakis GA. The use of the Ligasure Vessel Sealing System in parotid gland surgery. Otolaryngol Head Neck Surg. 2005 Nov;133(5):725-8. doi: 10.1016/j.otohns.2005.06.030.
• Bassiouny A, El Salamawy A, Abd El-Tawab M, Atef A. Bipolar radiofrequency treatment for snoring with mild to moderate sleep apnea: a comparative study between the radiofrequency assisted uvulopalatoplasty technique and the channeling technique. Eur Arch Otorhinolaryngol. 2007 Jun;264(6):659-67. doi: 10.1007/s00405-007-0244-x. Epub 2007 Feb 9.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): May 1, 2009
• Study Completion (Anticipated): September 1, 2009

Study Registration Dates

• First Submitted: December 10, 2008
• First Submitted That Met QC Criteria: December 10, 2008
• First Posted (Estimate): December 11, 2008

Study Record Updates

• Last Update Posted (Estimate): December 11, 2008
• Last Update Submitted That Met QC Criteria: December 10, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: bleeding; adverse effects; UPPP; uvulopalatoplasty; Vessel sealing system; uvulopalatal flap; operative time
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Sounds; Sleep Apnea, Obstructive; Snoring
• Other Study ID Numbers: ENTCU_pkk2008_02