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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemorrhage, Pain

Intervention / Treatment
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* Procedure: suture one tonsillar fossa


Participation Criteria
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Eligibility Criteria
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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
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: sutured one tonsillar fossa. pain was compared side to side. which side was sutured was randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: suture one tonsillar fossa<br>Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side. | Procedure: suture one tonsillar fossa<br>* one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.<br>|
| No Intervention: One side not sutured<br>Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 40 days | 
| any other adverse events (complications) | determined if other complications occurred | 40 days | 
| 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 | 21 days | 
| 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 | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, Tonsillectomy, Suturing of tonsillar pillars, postoperative hemorrhage, bleeding