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

Not Applicable

Completed

• Conditions: Hemorrhage; Pain
• Interventions: Procedure: suture one tonsillar fossa

• Registration Number: NCT00394849
• Lead Sponsor: Indiana University School of Medicine

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 Timeline

• Study Start: 2000-07
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2006-10-30
• Study First Submitted QC: 2006-10-30
• Study First Posted: 2006-11-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 763

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
suture one tonsillar fossa	suture one tonsillar fossa	Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Riley Childrens' Hospital; 🇺🇸 Indianapolis, Indiana, United States