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Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy

NCT ID: NCT00466544

Last Updated: 2007-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.

Detailed Description

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This is a prospective, randomized controlled study to compare the efficacy of the Gyrus ACMI PlasmaKnife™ electrosurgical device used with the Gyrus ACMI Workstation versus monopolar electrosurgical device (i.e. Bovie®) for tonsillectomy.

The primary outcome will study the potential for reduced post-operative pain when the PlasmaKnife is used for tonsillectomy compared to a monopolar device. Secondary outcomes such as return to normal diet and activity as well as a range of complications including primary and secondary bleeding will be included in the study.

The study will involve approximately 100 patients at Children's Hospital of Michigan that meet the criteria for tonsillectomy (with or without adenoidectomy) for infected tonsils or airway obstruction.

The study will be documented through the use of Case Report Forms.

Conditions

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Obstructive Tonsillar Hypertrophy Tonsillitis

Keywords

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Chronic tonsillitis Recurrent tonsillitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Plasmaknife

Intervention Type DEVICE

Monopolar

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient should be between the ages of 4 and 16 years old inclusive.
* Patient should meet criteria for tonsillectomy.
* Patient's guardian able and willing to complete patient diary and keep to the follow-up visit.
* Guardian able to understand English (written and oral).

Exclusion Criteria

* Patient that has active medical implant(s) such as pacemaker, cochlear implant, etc.
* Patient has abnormal blood coagulation, history of easy bruising, bleeding disorders or uses anti-coagulants.
* Morbidly obese children (calculated BMI over 39)
* Patient that has history of malignancy or acute peritonsillar abscess
* Patient has Sickle Cell disease or is immunocompromised.
* Patient is pregnant or lactating.
* Active infection with fever greater than 101.5 degrees F.
* History of heart disease, diabetes or hypertension (with systolic blood pressure \> 160 mmHg).
* Craniofacial anomaly.
* Biopsy of tonsil needed to rule out neoplasm.
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Michigan

OTHER

Sponsor Role lead

Principal Investigators

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David Madgy

Role: PRINCIPAL_INVESTIGATOR

Detroit Children's Hospital

Locations

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Detroit Children's Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

Facility Contacts

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David Madgy

Role: primary

Mary Ross

Role: backup

Other Identifiers

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036706MP4F

Identifier Type: -

Identifier Source: org_study_id