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OpenTrials
Completed

NCT Number: NCT00394849

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.

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Key information

Conditions

Hemorrhage Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riley Childrens' Hospital

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

suture one tonsillar fossa

Procedure

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

Primary outcomes

  1. which side was more painful on or about postoperative day 14

    Time frame: 14 days

    determined which side was more painful on or about postoperative day 14 by asking patient and/or care giver

Secondary outcomes

  1. Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event

    Time frame: 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

  2. any other adverse events (complications)

    Time frame: 40 days

    determined if other complications occurred

  3. which side was more painful on or about postoperative day 21

    Time frame: 21 days

    determined which side was more painful on or about postoperative day 21 by asking patient and/or care giver

  4. overall assessment at the postoperative clinic visit (on or about day 28)

    Time frame: 28 days

    determined overall assessment at the postoperative clinic visit (on or about day 28) by asking patient and/or care giver

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Nov 1, 2006
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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