Closure Method Study Following Tonsillectomy in Children

Decreased Morbidity With Closure of the Tonsillar Fossae

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00730340

Enrollment

Registered

2008-08-08

Start date

2008-08-31

Completion date

2010-06-30

Last updated

2010-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Tonsillectomy

Keywords

Tonsillectomy, tonsillar fossa, wound closure

Brief summary

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

Detailed description

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.

Interventions

PROCEDUREClosure of the Tonsillar Fossa

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.

PROCEDURETonsillectomy with open fossa

SOP for a tonsillectomy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 10 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure	6 months

Secondary

Measure	Time frame
The patients will also be examined in the clinic postoperatively to determine if the fossae remained closed or dehisced.	10-14 days postoperatively

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026