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

Indiana University School of Medicine763 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

763

Conditions

Hemorrhage Pain

Interventions

suture one tonsillar fossaPROCEDURE

one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Riley Childrens' Hospital

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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

Time frame: 14 days

Secondary Outcomes

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

Time frame: 40 days

any other adverse events (complications)

determined if other complications occurred

Time frame: 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

Time frame: 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

Time frame: 28 days

Data from ClinicalTrials.gov

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