NCT01319058

Outcome of Laser or Debrider Tonsillotomy Versus Tonsillectomy in Obstructive Sleep Apnea

Laser or Debrider Tonsillotomy Versus Monopolar Tonsillectomy in Obstructive Sleep Apnea; Inflammation as a Determinate of Outcome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines. the goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils.

Detailed description

Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines. the goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils. In the study three approaches are prospectively compared: 1. Tonsillectomy - using electrocautery resecting all tonsillar tissue. 2. Debrider Tonsillotomy - reducing the tonsillar tissue with a debrider. 3. laser Tonsillotomy - reducing tonsillar tissue using a CO2 laser. All patients will be randomized to one of three arms. Each arm will include 25 children. All children will have a preoperative and postoperative sleep study. Questioners assessing pain, amount of medication used to control pain and sleep disturbance during the first 7 days after surgery will be filled by the child caretaker. Blood will be drawn immediately before surgery and 18-24 hours after surgery. The following blood products will be assessed: White blood cells, clotting factors, C reactive protein, IL1 beta,TNF alpha, IL6, IL2. If the study will show objectively and subjectively that partial resection of the tonsil compared to complete tonsillectomy is less painful and has less postoperative inflammation.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
PROCEDURE	Tonsillectomy, laser tonsillotomy, debrider tonsillotomy	Each arm will be treated by one of the three methods in addition to adenoidectomy

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-01-01
• Completion: 2013-07-01
• First posted: 2011-03-21
• Last updated: 2016-10-18

Locations

1 site across 1 country: Israel