SnoringNCT00806637
Vessel Sealing System Uvulopalatoplasty Versus Uvulopalatal Flap
A study testing Vessel sealing system uvulopalatoplasty (VSSU) and Uvulopalatal flap (UPF) in people with Snoring and Obstructive Sleep Apnea, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Snoring, Obstructive Sleep Apnea
- What is being tested?
- Vessel sealing system uvulopalatoplasty (VSSU) and Uvulopalatal flap (UPF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient planned for uvulopalatoplasty for indications of snoring or obstructive sleep apnea
- Written informed consent form is given from patient
Who cannot join
- Pregnancy
- History of bleeding disorders
- Patient unable to understand evaluation method
- Patient unable to be contacted via telephone
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
Patumwan, Bangkok, 10330
About this study
Official title: 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.
Read the 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.
- Conditions
- Snoring, Obstructive Sleep Apnea
- Being tested
- Vessel sealing system uvulopalatoplasty (VSSU), Uvulopalatal flap (UPF)
- Keywords
- Vessel sealing system, uvulopalatoplasty, UPPP, uvulopalatal flap, bleeding, operative time, adverse effects
- Medical subject headings
- Snoring, Sleep Apnea, Obstructive, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vessel sealing system uvulopalatoplasty (VSSU)Procedure or surgery
Also called ligasure vessel sealing system
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)Procedure or surgery
Also called uvulopalatoplasty
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Uvulopalatal flap (UPF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
Measured: within the first 1 hour after surgery starting time
Secondary outcomes (4)
operative time
Measured: within the first 1 hour after surgery starting time
postoperative pain
Measured: within the first 14 days after surgery
postoperative bleeding
Measured: within the first 14 days after surgery
postoperative velopharyngeal insufficiency
Measured: within the first 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SnoringStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Prakobkiat Hirunwiwatkul, M.D., Principal investigator, Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806637
- Sponsor's protocol ID
- ENTCU_pkk2008_02
- Status last verified
- Oct 2008
- First submitted
- 10 Dec 2008
- Last updated
- 11 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17765762Powell 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.
PubMed 8899940Prokopakis 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.
PubMed 16274800Bassiouny 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.
PubMed 17294208
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vessel Sealing System Uvulopalatoplasty vs Uvulopalatal Flap: a Randomized, Control Study of Efficacy and Adverse Effects
- ClinicalTrials.gov ID
- NCT00806637
- Acronym / sponsor ID
- ENTCU_pkk2008_02
- Conditions
- Snoring, Obstructive Sleep Apnea
- Keywords
- Vessel sealing system, uvulopalatoplasty, UPPP, uvulopalatal flap, bleeding, operative time, adverse effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | 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. |
| 2 | Active comparator | 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient planned for uvulopalatoplasty for indications of snoring or obstructive sleep apnea
- Written informed consent form is given from patient
Key exclusion criteria (4 listed)
- Pregnancy
- History of bleeding disorders
- Patient unable to understand evaluation method
- Patient unable to be contacted via telephone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vessel sealing system uvulopalatoplasty (VSSU)Also: ligasure vessel sealing systemVessel 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 or surgery | 1 |
| Uvulopalatal flap (UPF)Also: uvulopalatoplastyUvulopalatal 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 or surgery | 2 |
Primary outcome
intraoperative blood loss
Time frame: within the first 1 hour after surgery starting time
4 secondary outcomes
operative time
Time frame: within the first 1 hour after surgery starting time
postoperative pain
Time frame: within the first 14 days after surgery
postoperative bleeding
Time frame: within the first 14 days after surgery
postoperative velopharyngeal insufficiency
Time frame: within the first 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2008.
- Results publication: PubMed 17765762Lachanas 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 publication: PubMed 8899940Powell 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 publication: PubMed 16274800Prokopakis 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 publication: PubMed 17294208Bassiouny 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prakobkiat Hirunwiwatkul, M.D. principal investigator
Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vessel sealing system uvulopalatoplasty (VSSU) and Uvulopalatal flap (UPF) in people with Snoring and Obstructive Sleep Apnea, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative blood loss (time frame: within the first 1 hour after surgery starting time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00806637, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2008.