Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
1 other identifier
interventional
763
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2000
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 30, 2006
CompletedFirst Posted
Study publicly available on registry
November 1, 2006
CompletedNovember 7, 2017
November 1, 2017
3.7 years
October 30, 2006
November 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
14 days
Secondary Outcomes (4)
Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event
40 days
any other adverse events (complications)
40 days
which side was more painful on or about postoperative day 21
21 days
overall assessment at the postoperative clinic visit (on or about day 28)
28 days
Study Arms (2)
suture one tonsillar fossa
EXPERIMENTALIntervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
One side not sutured
NO INTERVENTIONIntervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Interventions
one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any patient for whom tonsillectomy is recommended for suspected malignancy or active peritonsillar abscess
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riley Childrens' Hospital
Indianapolis, Indiana, 46202, United States
Related Publications (1)
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.
PMID: 23021465RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce H. Matt, MD, MS
Indiana University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- did not tell participant which side was sutured.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 30, 2006
First Posted
November 1, 2006
Study Start
July 1, 2000
Primary Completion
March 1, 2004
Study Completion
March 1, 2004
Last Updated
November 7, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share