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Completed

NCT Number: NCT04204681

Tonsillar Retractor-induced Subacute Submassive Tongue Edema

This study aimed to detect tongue edema induced by the pressure exerted by tonsillar retractor; edema detection was made through tongue area measurement using ultrasonography (USG) in pediatric patients who underwent tonsillectomy surgeries.

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Key information

Conditions

Side Effects Children, Only Tonsil Hypertrophy

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

About this study

The tongue is an ideal organ for ultrasonography (USG) evaluation. This study aimed to detect the occurrence of tongue edema through USG examination and to educate clinicians about the association between subacute tongue edema and tonsillar retractor in pediatric patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

for study group:

  • Patients aged 16 years or younger
  • Undergo tonsillectomy surgery
  • Patients informed consent obtained from the parents

Exclusion criteria

for study group:

  • Patients aged older than 16 years
  • Patients with a history of syndromal craniofacial abnormalities
  • Patients with systemic disorders and other otolaryngologic problems

Inclusion criteria

for control group:

  • Patients aged 16 years or younger
  • Patients who did not need tonsillectomy surgery and any head and neck procedures
  • Patients who underwent endotracheal intubation under general anesthesia except tonsillectomy and head and neck surgery.

Treatment and study plan

Ultrasonography imaging

Diagnostic Test

This study aimed to measure the tongue areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue areas.

Primary outcomes

  1. Change from preoperative measurement to postoperative measurement in tongue area on the ultrasonography imaging.

    Time frame: 2018-2019 (6 months)

    This study aimed to evaluate the change from baseline in tongue area on the ultrasonography imaging due to the tonsillar retractor.

Secondary outcomes

  1. Detection of edema formation in tongue by using ultrasonography imaging.

    Time frame: 2018-2019 (6 months)

    This study aimed to measure and detect the tongue edema by using ultrasonography imaging due to the tonsillar retractor.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

Tonsillar Retractor-induced Subacute Submassive Tongue Edema: A New Cause of Late Respiratory Complications in Pediatric Patients Undergoing Tonsillectomy and a Condition Detected by Ultrasonography

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2019
Registry last updated
Dec 20, 2019

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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