Study of Efficacy and Adverse Effects: Vessel Sealing System Tonsillectomy Versus Cold Knife Tonsillectomy
NCT ID: NCT00636402
Last Updated: 2008-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2008-03-31
2008-12-31
Brief Summary
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Detailed Description
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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. This study was planned to compare vessel sealing system tonsillectomy (VSST) to the traditional cold knife tonsillectomy (CKT) with special regard to intraoperative bleeding, operative time, postoperative pain and hemorrhage.
Inclusion criteria are patients planned for tonsillectomy for indications of chronic tonsillitis or obstructive sleep apnea and written informed consent form is given from patient or patient's parents (in case of pediatric patient).
Exclusion criteria are pregnancy, history of bleeding disorders, unilateral tonsillectomy, much different size of both tonsils (If the difference is more than or equal to 2, it will be defined as much different in size in this study), patient unable to understand evaluation method or unable to be contacted via telephone. Outcome measurements are the following.
1. Operative time (minutes) will be started at the time of incision and ended at the time of complete hemostasis. After tonsillectomy on the first side is finished, 5-10 minutes is the lag time before tonsillectomy on the second side will be started in order to observe re-bleeding after operative time is recorded. If there is re-bleeding, the operative time will be changed and measured from the same starting time to the time of last complete hemostasis.
2. Amount of blood loss (milliliter) will be measured from amount of fluid including blood and saliva in the container and gauze. Measurement will be started at the time of incision and ended at the time of complete hemostasis in the same manner of operative time.
3. Pain score, postoperative hemorrhage or other adverse effects that the research assistant will record on post-op day 0-14 by using direct and telephone interview.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Vessel Sealing System Tonsillectomy (VSST)
Vessel Sealing System Tonsillectomy
Intervention by Vessel Sealing System Tonsillectomy (VSST) will be randomized and will be performed on one side.
2
Cold Knife Tonsillectomy (CKT)
Cold Knife Tonsillectomy
Cold Knife Tonsillectomy (CKT) will be done on the other side.
Interventions
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Cold Knife Tonsillectomy
Cold Knife Tonsillectomy (CKT) will be done on the other side.
Vessel Sealing System Tonsillectomy
Intervention by Vessel Sealing System Tonsillectomy (VSST) will be randomized and will be performed on one side.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent form is given from patient or patient's parents (in case of pediatric patient)
Exclusion Criteria
* History of bleeding disorders
* Unilateral tonsillectomy
* Much difference in size of both tonsils (if the difference is more than or equal to 2, it will be defined as much different in size in this study)
* Patient unable to understand evaluation method
* Patient unable to be contacted via telephone
ALL
No
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Faculty of Medicine, Chulalongkorn University, Thailand
Principal Investigators
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Prakobkiat Hirunwiwatkul, M.D.
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, Chulalongkorn University, Thailand
Locations
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Department of Otolaryngology, King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, Thailand
Countries
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References
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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.
Lachanas VA, Prokopakis EP, Bourolias CA, Karatzanis AD, Malandrakis SG, Helidonis ES, Velegrakis GA. Ligasure versus cold knife tonsillectomy. Laryngoscope. 2005 Sep;115(9):1591-4. doi: 10.1097/01.mlg.0000172044.57285.b6.
Prokopakis EP, Lachanas VA, Benakis AA, Helidonis ES, Velegrakis GA. Tonsillectomy using the Ligasure vessel sealing system. A preliminary report. Int J Pediatr Otorhinolaryngol. 2005 Sep;69(9):1183-6. doi: 10.1016/j.ijporl.2005.03.042.
Lister MT, Cunningham MJ, Benjamin B, Williams M, Tirrell A, Schaumberg DA, Hartnick CJ. Microdebrider tonsillotomy vs electrosurgical tonsillectomy: a randomized, double-blind, paired control study of postoperative pain. Arch Otolaryngol Head Neck Surg. 2006 Jun;132(6):599-604. doi: 10.1001/archotol.132.6.599.
Newman CJ, Lolekha R, Limkittikul K, Luangxay K, Chotpitayasunondh T, Chanthavanich P. A comparison of pain scales in Thai children. Arch Dis Child. 2005 Mar;90(3):269-70. doi: 10.1136/adc.2003.044404.
Other Identifiers
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ENTCU_pkk2008_01
Identifier Type: -
Identifier Source: org_study_id