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 28, 2015
Last verified: August 2015

October 30, 2006
August 28, 2015
July 2000
March 2004   (final data collection date for primary outcome measure)
  • 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 ]
  • 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)
  • 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
Complete list of historical versions of study NCT00394849 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Hemorrhage
  • Pain
Procedure: suturing of tonsillar pillars after tonsillectomy
Not Provided
Matt BH, Krol BJ, Ding Y, Juliar BE. Effect of tonsillar fossa closure on postoperative pain and bleeding risk after tonsillectomy. Int J Pediatr Otorhinolaryngol. 2012 Dec;76(12):1799-805. doi: 10.1016/j.ijporl.2012.09.004. Epub 2012 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
763
March 2004
March 2004   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00394849
0006-26
No
Bruce H. Matt, MD, MS, Indiana University
Indiana University School of Medicine
Not Provided
Principal Investigator: Bruce H. Matt, MD, MS Indiana University School of Medicine
Indiana University
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP