Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519402
Status:
WITHDRAWN
Last Update Posted:
2017-11-13
First Post:
2007-08-21
Brief Title:
Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing in Children
Status:
WITHDRAWN
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 300000 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
Background and Significance Tonsillectomy is the most common major surgical procedure performed on children in the United States with nearly 300000 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None