Study of Efficacy and Adverse Effects: Vessel Sealing System Tonsillectomy Versus Cold Knife Tonsillectomy
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|ClinicalTrials.gov Identifier: NCT00636402|
Recruitment Status : Unknown
Verified December 2008 by Chulalongkorn University.
Recruitment status was: Enrolling by invitation
First Posted : March 14, 2008
Last Update Posted : December 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Tonsillitis Obstructive Sleep Apnea||Procedure: Cold Knife Tonsillectomy Procedure: Vessel Sealing System Tonsillectomy||Not Applicable|
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.
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Vessel Sealing System Tonsillectomy vs Cold Knife Tonsillectomy: A Randomized, Paired Control Study of Efficacy and Adverse Effects|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||December 2008|
|Estimated Study Completion Date :||December 2008|
Vessel Sealing System Tonsillectomy (VSST)
Procedure: Vessel Sealing System Tonsillectomy
Intervention by Vessel Sealing System Tonsillectomy (VSST) will be randomized and will be performed on one side.
Other Name: VSST
Active Comparator: 2
Cold Knife Tonsillectomy (CKT)
Procedure: Cold Knife Tonsillectomy
Cold Knife Tonsillectomy (CKT) will be done on the other side.
Other Name: CKT
- Intra-operative time [ Time Frame: 1 day ]
- Intra-operative blood loss [ Time Frame: 1 day ]
- Pain, postoperative [ Time Frame: 14 days ]
- Postoperative bleeding and other adverse effects [ Time Frame: 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636402
|Department of Otolaryngology, King Chulalongkorn Memorial Hospital|
|Bangkok, Thailand, 10330|
|Principal Investigator:||Prakobkiat Hirunwiwatkul, M.D.||Faculty of Medicine, Chulalongkorn University, Thailand|