Natural History of Infants With Patent Processus Vaginalis
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
This will be a multi-center prospective observational study of all patients who undergo laparoscopic pyloromyotomy. Subjects who have PPV will be followed up to just before their 18th birthday through annual phone calls or emails to determine the incidence and timing of subsequent inguinal hernia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 4 months
Healthy Volunteers: f
View:
• 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
Locations
United States
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
Contact Information
Primary
Shawn D St. Peter, MD
sspeter@cmh.edu
816-234-3575
Backup
Emina Dizdarevic, MA
edizdarevic@cmh.edu
816-983-6852
Time Frame
Start Date: 2017-01
Estimated Completion Date: 2036-12
Participants
Target number of participants: 1000
Treatments
Infants with PPV
During laparoscopy for pyloric stenosis, the surgeon will turn the camera downward to answer the first question, whether the inguinal canal is patent or closed. If a PPV is present, the subject will be followed for up to 18 years of age.
Infants without PPV
During laparoscopy for pyloric stenosis, the surgeon will turn the camera downward to answer the first question, whether the inguinal canal is patent or closed. If there is no PPV, meaning they have normal anatomy, the patient demographic data will be recorded and this will terminate their participation.
Related Therapeutic Areas
Sponsors
Collaborators: C.S. Mott Children's Hospital, Nationwide Children's Hospital, Norton Children's Hospital, American Family Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, Children's Hospital and Health System Foundation, Wisconsin, James Whitcomb Riley Hospital for Children, University of Chicago
Leads: Children's Mercy Hospital Kansas City