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Completed

NCT Number: NCT00730340

Closure Method Study Following Tonsillectomy in Children

This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae closure compared to without closure of the operative wound.

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Key information

Conditions

Tonsillectomy Children

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

This is a children's study. Patients experience significant postoperative pain, activity limitation and sometimes other significant postoperative complications. We are going to compare the effects of closing the tonsil wound versus non-closure. A daily journal will be kept (by the patient's parent or legal guardian)to log in measures of morbidity. Postoperative telephone calls will be made and scripted questions will be asked regarding any tonsillar hemorrhage requiring medical re-evaluation, and dehydration requiring medical re-evaluation. The patients will also be examined in the clinic at 10-14 days postoperatively to determine if the fossa remained closed or dehisced.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Normal children between that ages of five to ten requiring a tonsillectomy

Exclusion criteria

  • Children older than ten years of age.
  • Those children with identified syndromes, cleft palates and velopharyngeal insufficiency will not be eligible.

Treatment and study plan

Closure of the Tonsillar Fossa

Procedure

We hypothesize that closure of the tonsillar fossa decreases the morbidity of pain by decreasing exposure of the raw operative bed to oral secretions, mediation, and oral intake, and decreases the morbidity of post-operative hemorrhage by having the operative wound closed.

Tonsillectomy with open fossa

Procedure

SOP for a tonsillectomy.

Primary outcomes

  1. Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure

    Time frame: 6 months

Secondary outcomes

  1. The patients will also be examined in the clinic postoperatively to determine if the fossae remained closed or dehisced.

    Time frame: 10-14 days postoperatively

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Decreased Morbidity With Closure of the Tonsillar Fossae

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 8, 2008
Registry last updated
Jun 15, 2010

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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