Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00519402
First received: August 21, 2007
Last updated: March 26, 2008
Last verified: August 2007
  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

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

  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
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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. The Cleveland Clinic
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014