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Comparison of Floseal Hemostasis Tonsillectomy With Coblation Tonsillectomy and Cautery Hemostasis Tonsillectomy
This study is not yet open for participant recruitment.
Verified by Kaiser Permanente, July 2007
Sponsored by: Kaiser Permanente
Information provided by: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00459927
  Purpose

The purpose of this study is to evaluate a new method of hemostasis, floseal gel, in tonsillectomy and adenoidectomy, with the goal of decreasing post operative and intraoperative morbidity.


Condition Intervention Phase
Adenotonsillar Hypertrophy
Tonsillitis
Obstructive Sleep Apnea
Device: Floseal tonsillectomy
Device: Coblation tonsillectomy
Phase II
Phase III

MedlinePlus related topics: Sleep Apnea Tonsils and Adenoids
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title: Prospective, Controlled Clinical Trial of a Novel Hemostatic Sealant Versus Electrocautery Hemostasis and Coblation Dissection in Patients Undergoing Tonsillectomy

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood loss [ Time Frame: intraoperative period ]
  • Postoperative: Amount of pain medication required (day 1-14), subjective pain score, postoperative day # for returning to a normal diet and normal activity [ Time Frame: postoperative period ]

Estimated Enrollment: 102
Study Start Date: July 2007
Detailed Description:

Blood loss and postoperative morbidity following adenotonsillectomy in children can be significant. The current technique for performing a tonsillectomy is “cold steel tonsillectomy” with electocautery hemostasis and a newer technique of coblation tonsillectomy. Postoperative pain has been shown to be increased in patients undergoing extensive electrocautery, with less pain seen in patients undergoing coblation tonsillectomy. The purpose of the study is to evaluate the clinical efficacy and complications of Floseal matrix hemostatic sealant for use in patients undergoing adenotonsillectomy compared with two other currently used techniques.

The study is a prospective, controlled clinical trial comparing Floseal hemostasis in “cold steel” knife dissection tonsillectomy with cautery hemostasis in “cold steel” knife dissection tonsillectomy and coblation tonsillectomy in a pediatric population. All children under the age of 18 without previous documented coagulopathy scheduled to undergo tonsillectomy will be offered enrollment in the study. Informed consent will be obtained from the patient’s legal guardian. The goal of this study is to determine if Floseal reduces intraoperative blood loss, time to hemostasis, and postoperative morbidity in patients undergoing tonsillectomy compared with two other commonly used methods. Also, we wish to evaluate the complication rates following Floseal administration compared to those of electrocautery and coblation.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients less than 18 years old scheduled for a routine adenotonsillectomy

Exclusion Criteria:

  • Down syndrome
  • Craniofacial abnormality
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459927

Contacts
Contact: Siri Sunderi Cheng, M.D. 510 395 2827 siri.cheng@kp.org

Locations
United States, California
Kaiser Permanente Medical Center
Oakland, California, United States, 94612
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Joshua A Gottschall, M.D. Kaiser Permanente
  More Information

Study ID Numbers: CN-06JGott-01-b
Study First Received: April 11, 2007
Last Updated: July 2, 2007
ClinicalTrials.gov Identifier: NCT00459927  
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Adenotonsillectomy
Coblation tonsillectomy
Floseal

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Sleep Apnea Syndromes
Otorhinolaryngologic Diseases
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Sleep Disorders
Dyssomnias
Pharyngeal Diseases
Sleep Disorders, Intrinsic
Hypertrophy
Respiratory Tract Infections
Respiratory Tract Diseases
Tonsillitis
Stomatognathic Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009