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Sponsored by: |
Chulalongkorn University |
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Information provided by: | Chulalongkorn University |
ClinicalTrials.gov Identifier: | NCT00636402 |
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.
Condition | Intervention |
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Tonsillitis Obstructive Sleep Apnea |
Procedure: Cold Knife Tonsillectomy Procedure: Vessel Sealing System Tonsillectomy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Vessel Sealing System Tonsillectomy vs Cold Knife Tonsillectomy: A Randomized, Paired Control Study of Efficacy and Adverse Effects |
Enrollment: | 20 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Vessel Sealing System Tonsillectomy (VSST)
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Procedure: Vessel Sealing System Tonsillectomy
Intervention by Vessel Sealing System Tonsillectomy (VSST) will be randomized and will be performed on one side.
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2: Active Comparator
Cold Knife Tonsillectomy (CKT)
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Procedure: Cold Knife Tonsillectomy
Cold Knife Tonsillectomy (CKT) will be done on the other side.
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Tonsillectomy is one of the most common procedures performed by otolaryngologists. Intraoperative bleeding is a significant problem which requires hemostasis and causes prolonged operative time. Several different techniques are used to perform this operation. 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 and hemorrhage. 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Thailand | |
Department of Otolaryngology, King Chulalongkorn Memorial Hospital | |
Bangkok, Thailand, 10330 |
Principal Investigator: | Prakobkiat Hirunwiwatkul, M.D. | Faculty of Medicine, Chulalongkorn University, Thailand |
Responsible Party: | Faculty of Medicine, Chulalongkorn University, Thailand ( Assoc. Prof. Prakobkiat Hirunwiwatkul ) |
Study ID Numbers: | ENTCU_pkk2008_01 |
Study First Received: | March 7, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00636402 History of Changes |
Health Authority: | Thailand: Ethical Committee |
Vessel Sealing System Cold Knife Tonsillectomy Pain Postoperative |
Sleep Apnea Syndromes Otorhinolaryngologic Diseases Apnea Sleep Apnea, Obstructive Respiration Disorders Sleep Disorders Dyssomnias |
Pain Pharyngeal Diseases Sleep Disorders, Intrinsic Respiratory Tract Diseases Respiratory Tract Infections Tonsillitis Stomatognathic Diseases |
Sleep Apnea Syndromes Otorhinolaryngologic Diseases Apnea Sleep Apnea, Obstructive Respiration Disorders Nervous System Diseases Dyssomnias |
Sleep Disorders Pharyngeal Diseases Sleep Disorders, Intrinsic Respiratory Tract Diseases Respiratory Tract Infections Tonsillitis Stomatognathic Diseases |