Study of Efficacy and Adverse Effects: Vessel Sealing System Tonsillectomy Versus Cold Knife Tonsillectomy
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Purpose
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 |
|---|---|
|
Tonsillitis Obstructive Sleep Apnea |
Procedure: Cold Knife Tonsillectomy Procedure: Vessel Sealing System Tonsillectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Vessel Sealing System Tonsillectomy vs Cold Knife Tonsillectomy: A Randomized, Paired Control Study of Efficacy and Adverse Effects |
- Intra-operative time [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
- Intra-operative blood loss [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
- Pain, postoperative [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- Postoperative bleeding and other adverse effects [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Experimental: 1
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
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient planned for tonsillectomy for indications of chronic tonsillitis or obstructive sleep apnea
- Written informed consent form is given from patient or patient's parents (in case of pediatric patient)
Exclusion Criteria:
- Pregnancy
- 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
Contacts and Locations| Thailand | |
| Department of Otolaryngology, King Chulalongkorn Memorial Hospital | |
| Bangkok, Thailand, 10330 | |
| Principal Investigator: | Prakobkiat Hirunwiwatkul, M.D. | Faculty of Medicine, Chulalongkorn University, Thailand |
More Information
Publications:
| Responsible Party: | Assoc. Prof. Prakobkiat Hirunwiwatkul, Faculty of Medicine, Chulalongkorn University, Thailand |
| ClinicalTrials.gov Identifier: | NCT00636402 History of Changes |
| Other Study ID Numbers: | ENTCU_pkk2008_01 |
| Study First Received: | March 7, 2008 |
| Last Updated: | December 10, 2008 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Chulalongkorn University:
|
Vessel Sealing System Cold Knife Tonsillectomy Pain Postoperative |
Additional relevant MeSH terms:
|
Tonsillitis Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Pharyngitis Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
Glucuronyl glucosamine glycan sulfate Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013