Observing infants with a specific type of hernia
Natural History of Infants With Patent Processus Vaginalis
This study is following infants with a specific type of hernia to see how often they develop more hernias as they grow up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 1 Day to 4 Months |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT03042858 on ClinicalTrials.gov |
What this trial studies
This observational study will follow infants undergoing laparoscopic pyloromyotomy to assess the natural history of those with patent processus vaginalis (PPV). Participants will be monitored through annual communications until they are 18 years old to track the incidence and timing of any subsequent inguinal hernias. Data will be collected and managed through a centralized REDCap database, ensuring secure handling of participant information. The study aims to provide insights into the long-term outcomes of infants with PPV.
Who should consider this trial
Good fit: Ideal candidates are infants under four months old who are undergoing laparoscopic surgery for pyloric stenosis.
Not a fit: Patients with known hernias, undescended testes, or those undergoing open pyloromyotomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of the risks associated with PPV and inform better management strategies for affected infants.
How similar studies have performed: While this study focuses on a specific cohort, similar observational studies have provided valuable insights into pediatric hernia outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients having laparoscopic surgery for pyloric stenosis. Subjects are anticipated to be less than four months of age at the time of enrollment. * Enrollment inclusion dates: 08/2016 (upon IRB approval) to 7/31/2025 Exclusion Criteria: * Patients who are anticipated to have a hostile abdomen for visualizing the inguinal rings (e.g. gastroschisis, necrotizing enterocolitis) * Patients who have unilateral or bilateral undescended testes * Patients undergoing open pyloromyotomy * Patients who have a known hernia
Where this trial is running
Kansas City, Missouri
- Children's Mercy Hospital — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Shawn D St. Peter, MD — Children's Mercy Hospital Kansas City
- Study coordinator: Shawn D St. Peter, MD
- Email: sspeter@cmh.edu
- Phone: 816-234-3575
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.