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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, Tonsillectomy, Tonsillotomy, Inflammation, Pain, Post tonsillectomy bleeding

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Soroka Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Electrocautery tonsillectomy

Debrider tonsillotomy

Laser tonsillotomy

Arm Description

Children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea

Children undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea.

Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea.

Outcomes

Primary Outcome Measures

Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6.

Secondary Outcome Measures

Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance.

Full Information

First Posted
March 17, 2011
Last Updated
October 15, 2016
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01319058
Brief Title
Outcome of Laser or Debrider Tonsillotomy Versus Tonsillectomy in Obstructive Sleep Apnea
Acronym
TVLOD
Official Title
Laser or Debrider Tonsillotomy Versus Monopolar Tonsillectomy in Obstructive Sleep Apnea; Inflammation as a Determinate of Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Tonsillectomy - using electrocautery resecting all tonsillar tissue. Debrider Tonsillotomy - reducing the tonsillar tissue with a debrider. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, Tonsillectomy, Tonsillotomy, Inflammation, Pain, Post tonsillectomy bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrocautery tonsillectomy
Arm Type
Active Comparator
Arm Description
Children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea
Arm Title
Debrider tonsillotomy
Arm Type
Active Comparator
Arm Description
Children undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea.
Arm Title
Laser tonsillotomy
Arm Type
Active Comparator
Arm Description
Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea.
Intervention Type
Procedure
Intervention Name(s)
Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
Intervention Description
Each arm will be treated by one of the three methods in addition to adenoidectomy
Primary Outcome Measure Information:
Title
Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc M Puterman, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aviv D Goldbart, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Soroka Hospital
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
14746381
Citation
Friedman BC, Hendeles-Amitai A, Kozminsky E, Leiberman A, Friger M, Tarasiuk A, Tal A. Adenotonsillectomy improves neurocognitive function in children with obstructive sleep apnea syndrome. Sleep. 2003 Dec 15;26(8):999-1005. doi: 10.1093/sleep/26.8.999.
Results Reference
background
PubMed Identifier
19539380
Citation
Ericsson E, Lundeborg I, Hultcrantz E. Child behavior and quality of life before and after tonsillotomy versus tonsillectomy. Int J Pediatr Otorhinolaryngol. 2009 Sep;73(9):1254-62. doi: 10.1016/j.ijporl.2009.05.015. Epub 2009 Jun 17.
Results Reference
background
PubMed Identifier
16374970
Citation
Anand A, Vilela RJ, Guarisco JL. Intracapsular versus standard tonsillectomy: review of literature. J La State Med Soc. 2005 Sep-Oct;157(5):259-61.
Results Reference
background
PubMed Identifier
32347984
Citation
Blackshaw H, Springford LR, Zhang LY, Wang B, Venekamp RP, Schilder AG. Tonsillectomy versus tonsillotomy for obstructive sleep-disordered breathing in children. Cochrane Database Syst Rev. 2020 Apr 29;4(4):CD011365. doi: 10.1002/14651858.CD011365.pub2.
Results Reference
derived

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

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