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

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ClinicalTrials.gov Identifier: NCT01319058
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Ben-Zion Joshua, Soroka University Medical Center

March 17, 2011
March 21, 2011
October 18, 2016
August 2010
January 2013   (Final data collection date for primary outcome measure)
Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6. [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01319058 on ClinicalTrials.gov Archive Site
Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance. [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Obstructive Sleep Apnea
Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
Each arm will be treated by one of the three methods in addition to adenoidectomy
  • Active Comparator: Electrocautery tonsillectomy
    Children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea
    Intervention: Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
  • Active Comparator: Debrider tonsillotomy
    Children undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea.
    Intervention: Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
  • Active Comparator: Laser tonsillotomy
    Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea.
    Intervention: Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
75
July 2013
January 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
2 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01319058
sor495810ctil
No
Not Provided
Not Provided
Ben-Zion Joshua, Soroka University Medical Center
Soroka University Medical Center
Not Provided
Principal Investigator: Marc M Puterman, MD Soroka University Medical Center
Study Director: Aviv D Goldbart, MD Soroka University Medical Center
Soroka University Medical Center
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP