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

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.
 
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

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


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


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
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Israel
Soroka Hospital
Beer Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Principal Investigator: Marc M Puterman, MD Soroka University Medical Center
Study Director: Aviv D Goldbart, MD Soroka University Medical Center
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ben-Zion Joshua, MD, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01319058    
Other Study ID Numbers: sor495810ctil
First Posted: March 21, 2011    Key Record Dates
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:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases