Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing

November 8, 2017 updated by: michael macknin, The Cleveland Clinic

Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing in Children

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.

Study Overview

Status

Status

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Withdrawn

Conditions

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Intervention / Treatment

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Study Type

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Observational

Contacts and Locations

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Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

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Eligibility Criteria

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Ages Eligible for Study

5 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients undergoing tonsillectomies at the Cleveland Clinic from 1998-2002

Description

Inclusion Criteria:

  • Pediatric patients undergoing tonsillectomies at the Cleveland Clinic from 1998-2002

Study Plan

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How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Partial Tonsillectomy
Patients who received a partial tonsillectomy
Other: tonsillar examination and questionnaire completion
Complete Tonsillectomy
Patients who received a complete tonsillectomy
Other: tonsillar examination and questionnaire completion

Collaborators and Investigators

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Sponsor

Sponsor

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The Cleveland Clinic

Investigators

Investigators

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  • Principal Investigator: Michael L Macknin, M.D., The Cleveland Clinic

Study record dates

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Study Registration Dates

First Submitted

First Submitted

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August 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

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August 21, 2007

First Posted (Estimate)

First Posted

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August 22, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

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November 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

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Other Study ID Numbers

Other Study ID Numbers

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  • 07-433

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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