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

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00394849
First received: October 30, 2006
Last updated: August 6, 2009
Last verified: August 2009
  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

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:
  • 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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Bruce H. Matt, MD, MS, Indiana University
ClinicalTrials.gov Identifier: NCT00394849     History of Changes
Other Study ID Numbers: 0006-26
Study First Received: October 30, 2006
Last Updated: August 6, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hemorrhage
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014