Vessel Sealing System Uvulopalatoplasty Versus Uvulopalatal Flap

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00806637
First received: December 10, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

December 10, 2008
December 10, 2008
October 2008
May 2009   (final data collection date for primary outcome measure)
intraoperative blood loss [ Time Frame: within the first 1 hour after surgery starting time ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • operative time [ Time Frame: within the first 1 hour after surgery starting time ] [ Designated as safety issue: No ]
  • postoperative pain [ Time Frame: within the first 14 days after surgery ] [ Designated as safety issue: No ]
  • postoperative bleeding [ Time Frame: within the first 14 days after surgery ] [ Designated as safety issue: Yes ]
  • postoperative velopharyngeal insufficiency [ Time Frame: within the first 3 months after surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Snoring
  • Obstructive Sleep Apnea
  • 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 Name: ligasure vessel sealing system
  • 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 Name: uvulopalatoplasty
  • 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.
    Intervention: Procedure: Vessel sealing system uvulopalatoplasty (VSSU)
  • 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.
    Intervention: Procedure: Uvulopalatal flap (UPF)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
30
September 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00806637
ENTCU_pkk2008_02
Yes
Prakobkiat Hirunwiwatkul, Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
Chulalongkorn University
Not Provided
Principal Investigator: Prakobkiat Hirunwiwatkul, M.D. Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
Chulalongkorn University
October 2008

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