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Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing
This study has been withdrawn prior to recruitment.
Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00519402
  Purpose

Introduction: There is currently no long-term study, which compares the outcomes of partial tonsillectomy to conventional tonsillectomy. We hypothesize that there will be little significant tonsillar regrowth with partial tonsillectomy.

Background and Significance: Tonsillectomy is the most common major surgical procedure performed on children in the United States with nearly 300,000 procedures performed each year, primarily for the indication of obstructive sleep disordered breathing (OSDB). Conventional (total) tonsillectomy removes the tonsillar capsule, and partial tonsillectomy preserves the capsule by shaving away the tonsils using an endoscopic microdebrider. Partial tonsillectomy results in less pain, fewer days to normal activity and diet, and fewer days of analgesics than total tonsillectomy. There are no significant differences between the techniques in blood loss or postoperative life improved Historical evidence suggests that eventually there will be tonsillar regrowth with partial tonsillectomy. However, in a 2003 follow-up report of 243 children undergoing partial tonsillectomy and 107 undergoing complete tonsillectomy from 1998 through 2002 for OSDB there was no evidence of significant tonsillar regrowth. (1) We will follow-up children undergoing partial or complete tonsillectomies at the Cleveland Clinic from 1998 through 2002. There will be standardized tonsillar examinations by two observers, with a third observer in cases of significant disagreement, and questionnaires evaluating sleep apnea and daytime sleepiness, and number of tonsillar infections.

If there are a large number of children with recurrent tonsillar symptoms post partial tonsillectomy, the procedure should be abandoned. However, if follow-up reveals comparable tonsillar symptoms for partial and the total tonsillectomy, perhaps the partial procedure should replace the total tonsillectomy as the standard operation to relieve tonsillar OSDB. This could eventually result in millions of less lost days of work and school in the United States.


Condition Intervention
Partial Versus Complete Tonsillectomy for Obstruction Sleep Disordered Breathing
Other: tonsillar examination and questionnaire completion

MedlinePlus related topics: Tonsils and Adenoids
U.S. FDA Resources
Study Type: Observational
  Eligibility

Ages Eligible for Study:   5 Years to 28 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Pediatric patients undergoing tonsillectomies at the Cleveland Clinic from 1998-2002
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519402

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Michael L Macknin, M.D. Cleveland Clinic
  More Information

Study ID Numbers: 07-433
Study First Received: August 21, 2007
Last Updated: March 26, 2008
ClinicalTrials.gov Identifier: NCT00519402  
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
partial tonsillectomy
complete tonsillectomy
tonsillectomy
obstruction sleep disordered breathing OSDB
apnea

Study placed in the following topic categories:
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009