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Vessel Sealing System Uvulopalatoplasty Versus Uvulopalatal Flap

Primary Purpose

Snoring, Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Vessel sealing system uvulopalatoplasty (VSSU)
Uvulopalatal flap (UPF)
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring focused on measuring Vessel sealing system, uvulopalatoplasty, UPPP, uvulopalatal flap, bleeding, operative time, adverse effects

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

intraoperative blood loss

Secondary Outcome Measures

operative time
postoperative pain
postoperative bleeding
postoperative velopharyngeal insufficiency

Full Information

First Posted
December 10, 2008
Last Updated
December 10, 2008
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT00806637
Brief Title
Vessel Sealing System Uvulopalatoplasty Versus Uvulopalatal Flap
Official Title
Vessel Sealing System Uvulopalatoplasty vs Uvulopalatal Flap: a Randomized, Control Study of Efficacy and Adverse Effects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring, Obstructive Sleep Apnea
Keywords
Vessel sealing system, uvulopalatoplasty, UPPP, uvulopalatal flap, bleeding, operative time, adverse effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Vessel sealing system uvulopalatoplasty (VSSU)
Other Intervention Name(s)
ligasure vessel sealing system
Intervention Description
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 Type
Procedure
Intervention Name(s)
Uvulopalatal flap (UPF)
Other Intervention Name(s)
uvulopalatoplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
intraoperative blood loss
Time Frame
within the first 1 hour after surgery starting time
Secondary Outcome Measure Information:
Title
operative time
Time Frame
within the first 1 hour after surgery starting time
Title
postoperative pain
Time Frame
within the first 14 days after surgery
Title
postoperative bleeding
Time Frame
within the first 14 days after surgery
Title
postoperative velopharyngeal insufficiency
Time Frame
within the first 3 months after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prakobkiat Hirunwiwatkul, M.D.
Organizational Affiliation
Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
City
Patumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
17765762
Citation
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.
Results Reference
result
PubMed Identifier
8899940
Citation
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.
Results Reference
result
PubMed Identifier
16274800
Citation
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.
Results Reference
result
PubMed Identifier
17294208
Citation
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.
Results Reference
result

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Vessel Sealing System Uvulopalatoplasty Versus Uvulopalatal Flap

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