Clinical trial NCT00806637: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Snoring
Obstructive Sleep Apnea
Keywords: Vessel sealing system
uvulopalatoplasty
UPPP
uvulopalatal flap
bleeding
operative time
adverse effects
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2008-12-11
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: intraoperative blood loss
timeFrame: within the first 1 hour after surgery starting time
Secondary outcomes:
measure: operative time
timeFrame: within the first 1 hour after surgery starting time
measure: postoperative pain
timeFrame: within the first 14 days after surgery
measure: postoperative bleeding
timeFrame: within the first 14 days after surgery
measure: postoperative velopharyngeal insufficiency
timeFrame: within the first 3 months after surgery
Other outcomes:
Locations:
city: Patumwan
country: Thailand
facility: Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
state: Bangkok
Study officials:
affiliation: Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University
name: Prakobkiat Hirunwiwatkul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.