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

Obstructive Sleep Apnea Clinical Trial

Official title:

Vessel Sealing System Tonsillectomy vs Cold Knife Tonsillectomy: A Randomized, Paired Control Study of Efficacy and Adverse Effects

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00636402
• Other study ID #: ENTCU_pkk2008_01
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 7, 2008
• Last updated: December 10, 2008
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive
• Tonsillitis

Intervention

Procedure:
• Cold Knife Tonsillectomy
Cold Knife Tonsillectomy (CKT) will be done on the other side.
• Vessel Sealing System Tonsillectomy
Intervention by Vessel Sealing System Tonsillectomy (VSST) will be randomized and will be performed on one side.

Locations

Country	Name	City	State
Thailand	Department of Otolaryngology, King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

Lachanas VA, Hajiioannou JK, Karatzias GT, Filios D, Koutsias S, Mourgelas C. Comparison of LigaSure vessel sealing system, harmonic scalpel, and cold knife tonsillectomy. Otolaryngol Head Neck Surg. 2007 Sep;137(3):385-9. — View Citation

Lachanas VA, Prokopakis EP, Bourolias CA, Karatzanis AD, Malandrakis SG, Helidonis ES, Velegrakis GA. Ligasure versus cold knife tonsillectomy. Laryngoscope. 2005 Sep;115(9):1591-4. — View Citation

Lister MT, Cunningham MJ, Benjamin B, Williams M, Tirrell A, Schaumberg DA, Hartnick CJ. Microdebrider tonsillotomy vs electrosurgical tonsillectomy: a randomized, double-blind, paired control study of postoperative pain. Arch Otolaryngol Head Neck Surg. — View Citation

Newman CJ, Lolekha R, Limkittikul K, Luangxay K, Chotpitayasunondh T, Chanthavanich P. A comparison of pain scales in Thai children. Arch Dis Child. 2005 Mar;90(3):269-70. — View Citation

Prokopakis EP, Lachanas VA, Benakis AA, Helidonis ES, Velegrakis GA. Tonsillectomy using the Ligasure vessel sealing system. A preliminary report. Int J Pediatr Otorhinolaryngol. 2005 Sep;69(9):1183-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-operative time		1 day	Yes
Primary	Intra-operative blood loss		1 day	Yes
Primary	Pain, postoperative		14 days	Yes
Secondary	Postoperative bleeding and other adverse effects		14 days	Yes