NCT00806637

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

December 11, 2008

Status Verified

October 1, 2008

Enrollment Period

7 months

First QC Date

December 10, 2008

Last Update Submit

December 10, 2008

Conditions

SnoringObstructive Sleep Apnea

Keywords

Vessel sealing systemuvulopalatoplastyUPPPuvulopalatal flapbleedingoperative timeadverse effects

Outcome Measures

Primary Outcomes (1)

  • intraoperative blood loss

    within the first 1 hour after surgery starting time

Secondary Outcomes (4)

  • 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

Study Arms (2)

1

EXPERIMENTAL

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)

2

ACTIVE COMPARATOR

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)

Interventions

Vessel sealing system uvulopalatoplasty (VSSU)PROCEDURE

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.

Also known as: ligasure vessel sealing system
1
Uvulopalatal flap (UPF)PROCEDURE

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.

Also known as: uvulopalatoplasty
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University

Patumwan, Bangkok, 10330, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 17765762RESULT

  • 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.

    PMID: 8899940RESULT

  • 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.

    PMID: 16274800RESULT

  • 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.

    PMID: 17294208RESULT

MeSH Terms

Conditions

SnoringSleep Apnea, ObstructiveHemorrhage

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic Processes

Study Officials

  • Prakobkiat Hirunwiwatkul, M.D.

    Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 11, 2008

Study Start

October 1, 2008

Primary Completion

May 1, 2009

Study Completion

September 1, 2009

Last Updated

December 11, 2008

Record last verified: 2008-10

Locations

TH(1)