Natural History of Infants With Patent Processus Vaginalis

NCT03042858 | Active Not Recruiting

• 1 other identifier: 16020156
• Study Type: observational
• Target: 801
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patent Processus Vaginalis; Inguinal Hernia

Keywords

PPV; patent processus vaginalis; inguinal hernia

Outcome Measures

Primary Outcomes (1)

• Incidence of inguinal hernia

  frequency of the development of symptomatic inguinal hernia in infants who are found to have an opening in their inguinal canal during laparoscopy for pyloric stenosis

  18 years

Secondary Outcomes (1)

• Time to development of inguinal hernia

  18 years

Study Arms (2)

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.

Other: Infants with PPV

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.

Other: Infants without PPV

Interventions

Infants with PPV OTHER

Data will be collected for up to 18 years to monitor for inguinal hernia.

Infants with PPV

Infants without PPV OTHER

Basic data will be collected regarding the surgery and the subject's study participation will be complete.

Infants without PPV

Eligibility Criteria

• Age: 1 Day - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants undergoing laparoscopic pyloromyotomy.

You may qualify if:

• All patients having laparoscopic surgery for pyloric stenosis. Subjects are anticipated to be less than four months of age at the time of enrollment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Nationwide Children's Hospital: collaborator
• C.S. Mott Children's Hospital: collaborator
• University of Chicago: collaborator
• American Family Children's Hospital: collaborator
• Children's Hospital and Health System Foundation, Wisconsin: collaborator
• Norton Children's Hospital: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• James Whitcomb Riley Hospital for Children: collaborator

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Predictive Value of Tests

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensitivity and Specificity; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Shawn D St. Peter, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 3, 2017
• Study Start: January 1, 2017
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2036
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: duration of study
• Access Criteria: REDCap

Locations

US (1)