Trial record 6 of 76 for:    pillar

Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy

This study has been completed.
Information provided by:
Indiana University Identifier:
First received: October 30, 2006
Last updated: August 28, 2015
Last verified: August 2015
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
Procedure: suturing of tonsillar pillars after tonsillectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy

Resource links provided by NLM:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • which side was more painful on or about postoperative day 14 [ Time Frame: 14 days ]
  • which side was more painful on or about postoperative day 21 [ Time Frame: 21 days ]
  • overall assessment at the postoperative clinic visit (on or about day 28) [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event [ Time Frame: 40 days ]
  • any other adverse events (complications) [ Time Frame: 40 days ]

Enrollment: 763
Study Start Date: July 2000
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
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.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00394849

United States, Indiana
Riley Childrens' Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Principal Investigator: Bruce H. Matt, MD, MS Indiana University School of Medicine
  More Information

Responsible Party: Bruce H. Matt, MD, MS, Indiana University Identifier: NCT00394849     History of Changes
Other Study ID Numbers: 0006-26
Study First Received: October 30, 2006
Last Updated: August 28, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Suturing of tonsillar pillars
postoperative hemorrhage, bleeding

Additional relevant MeSH terms:
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Signs and Symptoms processed this record on November 24, 2015