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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy

• Registration Number: NCT01319058
• Lead Sponsor: Soroka University Medical Center

Brief 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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Primary Completion: 2013-01
• Study Completion: 2013-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-15
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

age 2-16 obstructive sleep apnea AHI>5 Hypertrophy of tonsils and adenoids

Exclusion Criteria

Children with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser tonsillotomy	Tonsillectomy, laser tonsillotomy, debrider tonsillotomy	Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea.
Debrider tonsillotomy	Tonsillectomy, laser tonsillotomy, debrider tonsillotomy	Children undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea.
Electrocautery tonsillectomy	Tonsillectomy, laser tonsillotomy, debrider tonsillotomy	Children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea

Primary Outcome Measures

Name	Time	Method
Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6.	12 months

Secondary Outcome Measures

Name	Time	Method
Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance.	12 months

Trial Locations

Locations (1)

Soroka Hospital; 🇮🇱 Beer Sheva, Israel