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

NCT01319058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2016-10-18

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Tonsillectomy, laser tonsillotomy, debrider tonsillotomy

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

Sponsors & Collaborators

  • Soroka University Medical Center

    lead OTHER

Principal Investigators

  • Marc M Puterman, MD · Soroka University Medical Center

  • Aviv D Goldbart, MD · Soroka University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-01-31
Completion
2013-07-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01319058 on ClinicalTrials.gov