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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Soroka University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01319058
First received: March 17, 2011
Last updated: March 18, 2011
Last verified: March 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Soroka University Medical Center:

Primary Outcome Measures:
  • Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 75
Study Start Date: August 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: July 2011 (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

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319058

Contacts
Contact: Marc M Puterman, MD 972-524206500 puterman@netvision.net.il
Contact: Ben-Zion Joshua, MD 972-524226400 benzionj@clalit.org.il

Locations
Israel
Soroka Hospital Recruiting
Beer Sheva, Israel, 84101
Contact: Marc M Puterman, MD    972-4206500    puterman@netvision.net.il   
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: Marc Max Puterman M.D., Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01319058     History of Changes
Other Study ID Numbers: sor495810ctil
Study First Received: March 17, 2011
Last Updated: March 18, 2011
Health Authority: Israel: Clalit health Services

Keywords provided by 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
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 22, 2014