Study of Efficacy and Adverse Effects: Vessel Sealing System Tonsillectomy Versus Cold Knife Tonsillectomy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00636402
First received: March 7, 2008
Last updated: December 10, 2008
Last verified: December 2008
  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

Resource links provided by NLM:


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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Pharyngitis
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections
Sleep Apnea Syndromes
Sleep Disorders
Sleep Disorders, Intrinsic
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 23, 2014