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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suture one tonsillar fossa | Experimental | Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side. |
|
| One side not sutured | No Intervention | Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suture one tonsillar fossa | Procedure | one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce H. Matt, MD, MS | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Childrens' Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23021465 | Result | 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. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010146 | Pain |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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sutured one tonsillar fossa. pain was compared side to side. which side was sutured was randomized
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did not tell participant which side was sutured.
| 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 |
| D011183 | Postoperative Complications |