NCT01319058

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

2.4 years

First QC Date

March 17, 2011

Last Update Submit

October 15, 2016

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneaTonsillectomyTonsillotomyInflammationPainPost tonsillectomy bleeding

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (1)

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

    12 months

Study Arms (3)

Electrocautery tonsillectomy

ACTIVE COMPARATOR

Children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea

Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy

Debrider tonsillotomy

ACTIVE COMPARATOR

Children undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea.

Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy

Laser tonsillotomy

ACTIVE COMPARATOR

Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea.

Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy

Interventions

Tonsillectomy, laser tonsillotomy, debrider tonsillotomyPROCEDURE

Each arm will be treated by one of the three methods in addition to adenoidectomy

Debrider tonsillotomyElectrocautery tonsillectomyLaser tonsillotomy

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age 2-16 obstructive sleep apnea AHI\>5 Hypertrophy of tonsils and adenoids

You may not qualify if:

  • Children with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Hospital

Beersheba, 84101, Israel

Location

Related Publications (4)

  • 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.

    PMID: 14746381BACKGROUND

  • 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.

    PMID: 19539380BACKGROUND

  • 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.

    PMID: 16374970BACKGROUND

  • 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.

    PMID: 32347984DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveInflammationPain

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marc M Puterman, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

  • Aviv D Goldbart, MD

    Soroka University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 21, 2011

Study Start

August 1, 2010

Primary Completion

January 1, 2013

Study Completion

July 1, 2013

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

IL(1)