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
  Purpose

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.


Condition Intervention
Snoring
Obstructive Sleep Apnea
Procedure: Vessel sealing system uvulopalatoplasty (VSSU)
Procedure: Uvulopalatal flap (UPF)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vessel Sealing System Uvulopalatoplasty vs Uvulopalatal Flap: a Randomized, Control Study of Efficacy and Adverse Effects

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • intraoperative blood loss [ Time Frame: within the first 1 hour after surgery starting time ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: October 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: uvulopalatoplasty

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806637

Locations
Thailand
Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
Patumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Prakobkiat Hirunwiwatkul, M.D. Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
  More Information

Publications:
Responsible Party: Prakobkiat Hirunwiwatkul, Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00806637     History of Changes
Other Study ID Numbers: ENTCU_pkk2008_02
Study First Received: December 10, 2008
Last Updated: December 10, 2008
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
Vessel sealing system
uvulopalatoplasty
UPPP
uvulopalatal flap
bleeding
operative time
adverse effects

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Snoring
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014