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ATT Compared With ATE in OSAS Children

NCT01676181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2023-03-10

No results posted yet for this study

Summary

Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.

Conditions

  • Obstructive Sleep Apnea Syndrome in Children

Interventions

PROCEDURE

Adenotonsillectomy

Total removal of tonsils and adenoid tissue with cold-steel

PROCEDURE

Adenotonsillotomy

Partial removal of tonsils with coblation and total removal of adenoids with cold steel

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Danielle Friberg, MD, PhD · Karolinska University Hospital, ORL dep

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Sweden

Study Locations

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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 NCT01676181 on ClinicalTrials.gov