Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy - Full Text View

Sponsored by:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00394849

Purpose

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
Hemorrhage Pain	Procedure: suturing of tonsillar pillars after tonsillectomy

MedlinePlus related topics: Tonsils and Adenoids

U.S. FDA Resources

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

Further study details as provided by Indiana University:

Primary Outcome Measures:

date of surgery
experience of surgeon
method of tonsillectomy
method of hemostasis
side closed
known clotting abnormalities
which side was more painful on or about postoperative day 1 (the first 72 hours)
which side was more painful on or about postoperative day 7
which side was more painful on or about postoperative day 14
which side was more painful on or about postoperative day 21
overall assessment at the postoperative clinic visit (on or about day 28)

Secondary Outcome Measures:

Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event
any other adverse events (complications)
comments.

Estimated Enrollment:	763
Study Start Date:	July 2000
Estimated Study Completion Date:	March 2004

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Any patient for whom tonsillectomy is recommended for recurrent pharyngitis, obstructive sleep disorder, snoring, halitosis, feeding difficulty associated with adenotonsillar hypertrophy, and who in the investigator's opinion, is capable of providing reliable responses to post-operative follow-up questions as defined in this protocol.

Exclusion Criteria:

Any patient for whom tonsillectomy is recommended for suspected malignancy or active peritonsillar abscess

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394849

Locations

United States, Indiana
Riley Childrens' Hospital
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University School of Medicine

Investigators

Principal Investigator:

Bruce H. Matt, MD, MS

Indiana University School of Medicine

More Information

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

Keywords provided by Indiana University:

Tonsillectomy
Suturing of tonsillar pillars
pain
postoperative hemorrhage, bleeding

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Postoperative Hemorrhage

Pain
Hemorrhage
Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009