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Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing

NCT ID: NCT00519402

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Disordered Breathing

Keywords

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partial tonsillectomy complete tonsillectomy tonsillectomy obstruction sleep disordered breathing OSDB apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Partial Tonsillectomy

Patients who received a partial tonsillectomy

tonsillar examination and questionnaire completion

Intervention Type OTHER

Complete Tonsillectomy

Patients who received a complete tonsillectomy

tonsillar examination and questionnaire completion

Intervention Type OTHER

Interventions

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tonsillar examination and questionnaire completion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients undergoing tonsillectomies at the Cleveland Clinic from 1998-2002
Minimum Eligible Age

5 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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michael macknin

Staff, General Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael L Macknin, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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07-433

Identifier Type: -

Identifier Source: org_study_id