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

I

Indiana University School of Medicine

Status

Completed

Conditions

Hemorrhage
Pain

Treatments

Procedure: suture one tonsillar fossa

Study type

Interventional

Funder types

Other

Identifiers

NCT00394849
0006-26

Details and patient eligibility

About

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.

Full 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.

Enrollment

763 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

763 participants in 2 patient groups

suture one tonsillar fossa
Experimental group
Description:
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Treatment:
Procedure: suture one tonsillar fossa
One side not sutured
No Intervention group
Description:
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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