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

NCT ID: NCT00394849

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

763 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2004-03-31

Brief Summary

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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

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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.

Conditions

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Hemorrhage Pain

Keywords

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Tonsillectomy Suturing of tonsillar pillars pain postoperative hemorrhage, bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

sutured one tonsillar fossa. pain was compared side to side. which side was sutured was randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
did not tell participant which side was sutured.

Study Groups

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suture one tonsillar fossa

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

Group Type EXPERIMENTAL

suture one tonsillar fossa

Intervention Type PROCEDURE

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

One side not sutured

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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suture one tonsillar fossa

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Bruce Matt

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce H. Matt, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Riley Childrens' Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23021465 (View on PubMed)

Other Identifiers

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0006-26

Identifier Type: -

Identifier Source: org_study_id