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Sponsored by: |
Indiana University School of Medicine |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00394849 |
The purpose of this study is to determine if closing the tonsil fossa after tonsillectomy leads to less pain and bleeding risk than leaving it open to heal by secondary intention.
Condition | Intervention |
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Hemorrhage Pain |
Procedure: suturing of tonsillar pillars after tonsillectomy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy |
Estimated Enrollment: | 763 |
Study Start Date: | July 2000 |
Estimated Study Completion Date: | March 2004 |
After induction of appropriate general anesthesia, a tonsillectomy was performed and control of bleeding was achieved as is routine for the individual Otolaryngologist performing the procedure. Next the surgeon used 3-0 chromic (absorbable) sutures on tapered needles to close one tonsillar fossa but leave the tonsillar fossa on the other side open. The side chosen was determined by a computer generated schedule. Routine postoperative care was given.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Indiana | |
Riley Childrens' Hospital | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Bruce H. Matt, MD, MS | Indiana University School of Medicine |
Study ID Numbers: | 0006-26 |
Study First Received: | October 30, 2006 |
Last Updated: | November 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00394849 |
Health Authority: | United States: Institutional Review Board |
Tonsillectomy Suturing of tonsillar pillars pain postoperative hemorrhage, bleeding |
Signs and Symptoms Postoperative Complications Postoperative Hemorrhage |
Pain Hemorrhage Pain, Postoperative |
Pathologic Processes |