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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Hemorrhage
• Intervention / Treatment: Procedure: suture one tonsillar fossa

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 Type: Interventional
• Enrollment (Actual): 763
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Childrens' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: suture one tonsillar fossa; Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.	Procedure: suture one tonsillar fossa; one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
No Intervention: One side not sutured; Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Indiana University School of Medicine
• Investigators: Principal Investigator: Bruce H. Matt, MD, MS, Indiana University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2000
• Primary Completion (Actual): March 1, 2004
• Study Completion (Actual): March 1, 2004

Study Registration Dates

• First Submitted: October 30, 2006
• First Submitted That Met QC Criteria: October 30, 2006
• First Posted (Estimate): November 1, 2006

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: pain; Tonsillectomy; Suturing of tonsillar pillars; postoperative hemorrhage, bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Hemorrhage
• Other Study ID Numbers: 0006-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No