Back to resultsRandomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy (jPK)
Primary Purpose
Obstructive Tonsillar Hypertrophy, Tonsillitis
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Plasmaknife
Monopolar
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Tonsillar Hypertrophy focused on measuring Chronic tonsillitis, Recurrent tonsillitis
Eligibility Criteria
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.
Sites / Locations
- Detroit Children's Hospital
Outcomes
Primary Outcome Measures
pain
Secondary Outcome Measures
return to normal activity
return to normal diet
medication dose taken
Full Information
NCT ID
NCT00466544
First Posted
April 26, 2007
Last Updated
April 26, 2007
Sponsor
Children's Hospital of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT00466544
Brief Title
Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
Acronym
jPK
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Hospital of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Tonsillar Hypertrophy, Tonsillitis
Keywords
Chronic tonsillitis, Recurrent tonsillitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Plasmaknife
Intervention Type
Device
Intervention Name(s)
Monopolar
Primary Outcome Measure Information:
Title
pain
Secondary Outcome Measure Information:
Title
return to normal activity
Title
return to normal diet
Title
medication dose taken
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Madgy
Organizational Affiliation
Detroit Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Detroit Children's Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Madgy
Phone
313-745-9048
Email
dnmadgy@comcast.net
First Name & Middle Initial & Last Name & Degree
Mary Ross
Phone
(313) 745-9050
Email
mmross@dmc.org
First Name & Middle Initial & Last Name & Degree
David Madgy
12. IPD Sharing Statement
Learn more about this trial
Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
We'll reach out to this number within 24 hrs