Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 763
- Locations
- 2
- Primary Endpoint
- which side was more painful on or about postoperative day 14
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
did not tell participant which side was sutured.
Eligibility Criteria
- Sex
- All
- Accepts 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
Arms & Interventions
suture one tonsillar fossa
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Intervention: suture one tonsillar fossa (Procedure)
One side not sutured
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Outcomes
Primary Outcomes
which side was more painful on or about postoperative day 14
Time Frame: 14 days
determined which side was more painful on or about postoperative day 14 by asking patient and/or care giver
Secondary Outcomes
- overall assessment at the postoperative clinic visit (on or about day 28)(28 days)
- 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)
Investigators
Bruce Matt
Associate Professor
Indiana University School of Medicine