Hemorrhage, Pain
Conditions
Keywords
Tonsillectomy, Suturing of tonsillar pillars, pain, postoperative hemorrhage, bleeding
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.
Interventions
PROCEDUREsuture one tonsillar fossa
one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Sponsors
Indiana University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
did not tell participant which side was sutured.
Intervention model description
sutured one tonsillar fossa. pain was compared side to side. which side was sutured was randomized
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| which side was more painful on or about postoperative day 14 | 14 days | determined which side was more painful on or about postoperative day 14 by asking patient and/or care giver |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event | 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) | 40 days | determined if other complications occurred |
| which side was more painful on or about postoperative day 21 | 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) | 28 days | determined overall assessment at the postoperative clinic visit (on or about day 28) by asking patient and/or care giver |
Countries
United States
Outcome results
None listed