A Prospective, Observational, Multicenter Study on Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Superior Mesenteric Artery Syndrome
- Sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Enrollment
- 289
- Locations
- 2
- Primary Endpoint
- Define the normal range of values of the SMA angle
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice.
Detailed Description
Demographics data, clinical indications, ultrasound diagnosis, and ultrasound measurements will be recorded and stored on an database. Ultrasound measurements will be analyzed to define the normal range of values of Superior Mesenteric Artery (SMA) angle and Superior Mesenteric Artery - Aorta (SMA-A) distance in the pediatric population according to age, Body Mass Index (BMI), and fat parameters.
Investigators
Marirosa Cristallo Lacalamita
MD Principal investigator
Ente Ospedaliero Cantonale, Bellinzona
Eligibility Criteria
Inclusion Criteria
- •Male and female children
- •Age ranging from10 to 15 years, included
- •Abdominal ultrasound examination to be performed for indications other than gastrointestinal evaluation
- •Signed Informed Consent
Exclusion Criteria
- •Presence of a disease that could distort the anatomy around the SMA (e.g., abdominal mass, lymphadenopathy, severe scoliosis, free abdominal fluid)
- •Oncologic patients at risk of neoplastic cachexia.
Outcomes
Primary Outcomes
Define the normal range of values of the SMA angle
Time Frame: 1 day
Measurement in degree with its 95% confidence interval
Secondary Outcomes
- Define the normal range of values of the SMA-A distance D(1 day)
- Assess the association between the SMA angle and BMI categories(1 day)
- Define the normal range of values of the SMA-A distance LV(1 day)
- Define the normal range of values of the SMA angle (degree), SMA-A distance LV(1 day)