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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00394849
First Posted: November 1, 2006
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bruce Matt, Indiana University School of Medicine
October 30, 2006
November 1, 2006
November 7, 2017
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 ]
determined which side was more painful on or about postoperative day 14 by asking patient and/or care giver
  • 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)
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 ]
    Additional information was obtained about details if postoperative bleeding occurred. Specifically, if postoperative bleeding occurred, we sought to obtain as many details as possible about the events. Items such as when the postoperative bleeding occurred, what was done about it, where the subject was treated, and what the outcome was ( was the bleeding controlled, did the subject have other complications or concerns, etc. were elicited
  • any other adverse events (complications) [ Time Frame: 40 days ]
    determined if other complications occurred
  • which side was more painful on or about postoperative day 21 [ Time Frame: 21 days ]
    determined which side was more painful on or about postoperative day 21 by asking patient and/or care giver
  • overall assessment at the postoperative clinic visit (on or about day 28) [ Time Frame: 28 days ]
    determined overall assessment at the postoperative clinic visit (on or about day 28) by asking patient and/or care giver
  • 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
Intervention Model: Single Group Assignment
Intervention Model Description:
sutured one tonsillar fossa. pain was compared side to side. which side was sutured was randomized
Masking: Single (Participant)
Masking Description:
did not tell participant which side was sutured.
Primary Purpose: Treatment
  • Hemorrhage
  • Pain
Procedure: suture one tonsillar fossa
one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
  • Experimental: suture one tonsillar fossa
    Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
    Intervention: Procedure: suture one tonsillar fossa
  • No Intervention: One side not sutured
    Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
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
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00394849
0006-26
No
Not Provided
Plan to Share IPD: No
Bruce Matt, Indiana University School of Medicine
Indiana University School of Medicine
Not Provided
Principal Investigator: Bruce H. Matt, MD, MS Indiana University School of Medicine
Indiana University
November 2017

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