Observational study of patients with oesophageal atresia after surgery
Observational Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia: Comparison Between Posterolateral Thoracotomy and Axillary Muscle-sparing Minithoracotomy
This study looks at patients who had surgery for oesophageal atresia to see how their bones and muscles change over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 1 Day to 13 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 3 sites (Brescia and 2 other locations) |
| Trial ID | NCT06286826 on ClinicalTrials.gov |
What this trial studies
This observational cohort study focuses on patients who underwent surgical treatment for oesophageal atresia (EA) between 2011 and 2021. It aims to assess the incidence of musculoskeletal abnormalities in these patients over time. The study is multicentre and longitudinal, involving follow-up at various clinical centres. By analyzing the outcomes of surgical interventions, the study seeks to enhance understanding of the long-term effects of EA treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have been diagnosed with type III oesophageal atresia and underwent their first surgical operation between 2011 and 2021.
Not a fit: Patients who do not provide informed consent or who have not undergone surgery for oesophageal atresia during the specified period will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term health outcomes of patients with oesophageal atresia, potentially improving future treatment approaches.
How similar studies have performed: While there have been studies on oesophageal atresia, this specific observational approach focusing on long-term musculoskeletal outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with oesophageal atresia (type III according to Ladd's classification); * Patients who underwent their first operation for oesophageal atresia in the period 2011-2021 * Signature of written informed consent and consent to the study and privacy. Exclusion Criteria: * Not signature of written informed consent and consent to the study and privacy.
Where this trial is running
Brescia and 2 other locations
- Spedali Civili di Brescia — Brescia, Italy (Recruiting)
- Meyer Children's Hospital IRCCS — Florence, Italy (Recruiting)
- Ospedale Bambino Gesù di Roma — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Elisa Severi — Meyer Children's Hospital IRCCS
- Study coordinator: Elisa Sieri
- Email: elisa.sieri@meyer.it
- Phone: 055 5662900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.