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Study of Efficacy and Adverse Effects: Vessel Sealing System Tonsillectomy Versus Cold Knife Tonsillectomy
This study is enrolling participants by invitation only.
First Received: March 7, 2008   Last Updated: December 10, 2008   History of Changes
Sponsored by: Chulalongkorn University
Information provided by: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00636402
  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

MedlinePlus related topics: Sleep Apnea Tonsils and Adenoids
U.S. FDA Resources
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

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
1: Experimental
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.
2: Active Comparator
Cold Knife Tonsillectomy (CKT)
Procedure: Cold Knife Tonsillectomy
Cold Knife Tonsillectomy (CKT) will be done on the other side.

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.

  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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636402

Locations
Thailand
Department of Otolaryngology, King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Prakobkiat Hirunwiwatkul, M.D. Faculty of Medicine, Chulalongkorn University, Thailand
  More Information

Publications:
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

Keywords provided by Chulalongkorn University:
Vessel Sealing System
Cold Knife
Tonsillectomy
Pain
Postoperative

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009