Back to resultsEffect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
Primary Purpose
Hemorrhage, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
suture one tonsillar fossa
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhage focused on measuring Tonsillectomy, Suturing of tonsillar pillars, pain, postoperative hemorrhage, bleeding
Eligibility 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
Sites / Locations
- Riley Childrens' Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
suture one tonsillar fossa
One side not sutured
Arm Description
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Outcomes
Primary Outcome Measures
which side was more painful on or about postoperative day 14
determined which side was more painful on or about postoperative day 14 by asking patient and/or care giver
Secondary Outcome Measures
Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event
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)
determined if other complications occurred
which side was more painful on or about postoperative day 21
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)
determined overall assessment at the postoperative clinic visit (on or about day 28) by asking patient and/or care giver
Full Information
NCT ID
NCT00394849
First Posted
October 30, 2006
Last Updated
November 3, 2017
Sponsor
Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00394849
Brief Title
Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
Official Title
Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Pain
Keywords
Tonsillectomy, Suturing of tonsillar pillars, pain, postoperative hemorrhage, bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
sutured one tonsillar fossa. pain was compared side to side. which side was sutured was randomized
Masking
Participant
Masking Description
did not tell participant which side was sutured.
Allocation
Randomized
Enrollment
763 (Actual)
8. Arms, Groups, and Interventions
Arm Title
suture one tonsillar fossa
Arm Type
Experimental
Arm Description
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Arm Title
One side not sutured
Arm Type
No Intervention
Arm Description
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Intervention Type
Procedure
Intervention Name(s)
suture one tonsillar fossa
Intervention Description
one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Primary Outcome Measure Information:
Title
which side was more painful on or about postoperative day 14
Description
determined which side was more painful on or about postoperative day 14 by asking patient and/or care giver
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event
Description
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
Time Frame
40 days
Title
any other adverse events (complications)
Description
determined if other complications occurred
Time Frame
40 days
Title
which side was more painful on or about postoperative day 21
Description
determined which side was more painful on or about postoperative day 21 by asking patient and/or care giver
Time Frame
21 days
Title
overall assessment at the postoperative clinic visit (on or about day 28)
Description
determined overall assessment at the postoperative clinic visit (on or about day 28) by asking patient and/or care giver
Time Frame
28 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce H. Matt, MD, MS
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riley Childrens' Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23021465
Citation
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.
Results Reference
result
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Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
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