Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing

• ClinicalTrials.gov Identifier: NCT00519402
• Recruitment Status: Withdrawn
• First Posted: August 22, 2007
• Last Update Posted: November 13, 2017
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): michael macknin, The Cleveland Clinic

Study Description

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.

Condition or disease	Intervention/treatment
Obstructive Sleep Disordered Breathing	Other: tonsillar examination and questionnaire completion

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing in Children

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 28 Years (Child, Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Contacts and Locations

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

• Responsible Party: michael macknin, Staff, General Pediatrics, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00519402
• Other Study ID Numbers: 07-433
• First Posted: August 22, 2007
• Last Update Posted: November 13, 2017
• Last Verified: November 2017

Keywords provided by michael macknin, The Cleveland Clinic:

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

Additional relevant MeSH terms:

Respiratory Aspiration; Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases