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Obstructive Sleep Disordered BreathingNCT00519402

Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing

An observational study of Obstructive Sleep Disordered Breathing, run by The Cleveland Clinic at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 28 years
Conditions the study is for
Obstructive Sleep Disordered Breathing
What is being tested?
tonsillar examination and questionnaire completion
How many people
0 participants
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 28 years
  • All sexes
  • Child, Adult

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

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: 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.

Being tested
tonsillar examination and questionnaire completion
Keywords
partial tonsillectomy, complete tonsillectomy, tonsillectomy, obstruction sleep disordered breathing OSDB, apnea
Medical subject headings
Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tonsillar examination and questionnaire completionOther

Study groups in NCT00519402
Study groupRoleWhat they receive
Partial TonsillectomyPatients who received a partial tonsillectomy
Receives: Other: tonsillar examination and questionnaire completion
Complete TonsillectomyPatients who received a complete tonsillectomy
Receives: Other: tonsillar examination and questionnaire completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2007 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00519402
Sponsor's protocol ID
07-433
Status last verified
Nov 2017
First submitted
21 Aug 2007
Last updated
13 Nov 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Disordered Breathing, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.

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