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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01319058
First Posted: March 21, 2011
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ben-Zion Joshua, Soroka University Medical Center
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Laser or Debrider Tonsillotomy Versus Monopolar Tonsillectomy in Obstructive Sleep Apnea; Inflammation as a Determinate of Outcome

Resource links provided by NLM:


Further study details as provided by Ben-Zion Joshua, Soroka University Medical Center:

Primary Outcome Measures:
  • Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance. [ Time Frame: 12 months ]

Enrollment: 88
Study Start Date: August 2010
Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Electrocautery tonsillectomy
Children undergoing tonsillectomy and adenoidectomy for 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: Debrider tonsillotomy
Children undergoing debrider tonsillotomy + adenoidectomy for 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: Laser tonsillotomy
Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea.
Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
Each arm will be treated by one of the three methods in addition to adenoidectomy

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319058


Locations
Israel
Soroka Hospital
Beer Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Marc M Puterman, MD Soroka University Medical Center
Study Director: Aviv D Goldbart, MD Soroka University Medical Center
  More Information

Publications:
Responsible Party: Ben-Zion Joshua, MD, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01319058     History of Changes
Other Study ID Numbers: sor495810ctil
First Submitted: March 17, 2011
First Posted: March 21, 2011
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Ben-Zion Joshua, Soroka University Medical Center:
obstructive sleep apnea
Tonsillectomy
Tonsillotomy
Inflammation
Pain
Post tonsillectomy bleeding

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases