Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing

NCT00519402 | Withdrawn

• 1 other identifier: 07-433
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Disordered Breathing

Keywords

partial tonsillectomy; complete tonsillectomy; tonsillectomy; obstruction sleep disordered breathing OSDB; apnea

Study Arms (2)

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

Interventions

tonsillar examination and questionnaire completion OTHER

Complete Tonsillectomy; Partial Tonsillectomy

Eligibility Criteria

• Age: 5 Years - 28 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael L Macknin, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff, General Pediatrics

Study Record Dates

• First Submitted: August 21, 2007
• First Posted: August 22, 2007
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

US (1)