Natural History of Infants With Patent Processus Vaginalis (HxPPV)

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia; Patent Processus Vaginalis
• Intervention / Treatment: Other: Infants with PPV; Other: Infants without PPV

Detailed Description

Patients will be identified at the time the need for laparoscopic pyloromyotomy is determined by the consulting surgeon. After informed permission is obtained, demographic information will be collected on all subjects. Subjects who do not have PPV at the time of surgery will have no further data collected and their study participation will be complete. Subjects who have PPV will receive annual phone calls, emails, or other contact methods selected by the family, for up to before their 18th birthday or until they report having surgical inguinal hernia repair. Data will be recorded as noted on the master list and datasheet and entered into a REDCap database. All participating institutions will upload data into REDCap along with subject contact information so all follow up contact can be made by the coordinating center. All identifiable information in REDCap will be accessible by the coordinating center. Each enrolling center will have access to identifiers for their subjects only. Enrolling centers will be contacted and asked to update the contact information in REDCap if the coordinating center is not able to make contact with a subject. Subjects will also be given contact information for the coordinating center so they can provide updated information directly. Parents will be the main study contact for the duration of the study since no study interventions other than the phone call/email are required.

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. Many surgeons routinely perform this maneuver; it takes no more than 10 seconds to perform and adds no risk to the operation. The study will include a quick estimate of width and depth of the PPV as outlined in the datasheet to characterize the size of the opening. The first characterization will be the presence of CO2 in the scrotum/labia upon insufflation, which clarifies that the PPV provides wide continuity from the abdomen to beyond the inguinal canal. The second characterization will be an estimate of the width of the opening in millimeters. The next step will be to note whether the bottom of the defect is seen. This is, by definition, no if the answer to the first question is yes and this no longer applies. Therefore the no answer to this question will identify those with an open tunnel but no external insufflation. Finally, if the bottom is seen then an estimate will be made in millimeters.

If there is no PPV, meaning the patient presents normal anatomy, the patient demographic data will be recorded and this will terminate their participation.

If a PPV is present, the investigators will conduct annual phone calls, or other contact method of the family's choice, to ask questions about whether the child has been diagnosed with hernia, underwent hernia repair or currently has symptoms consistent with a hernia (questionnaire attached). Subjects will be followed until hernia repair or as long as possible, up to their 18th birthday.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Shawn D St. Peter, MD; Phone Number: 816-234-3575; Email: sspeter@cmh.edu
• Study Contact Backup: Name: Emina Dizdarevic, MA; Phone Number: 816-983-6852; Email: edizdarevic@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Children's Mercy Hospital
      • Contact: Shawn D St. Peter, MD; Phone Number: 816-983-6479; Email: sspeter@cmh.edu
      • Principal Investigator: Shawn D St. Peter, MD
      • Contact: Emina Dizdarevic, MA; Phone Number: 816 983 7852; Email: edizdarevic@cmh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants undergoing laparoscopic pyloromyotomy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Data will be collected for up to 18 years to monitor for inguinal hernia.
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; Basic data will be collected regarding the surgery and the subject's study participation will be complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to development of inguinal hernia	Timeframe to develop a symptomatic inguinal hernia in infants who are found to have an opening in their inguinal canal during laparoscopy for pyloric stenosis.	18 years

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: University of Chicago; Ann & Robert H Lurie Children's Hospital of Chicago; Nationwide Children's Hospital; Children's Hospital and Health System Foundation, Wisconsin; C.S. Mott Children's Hospital; James Whitcomb Riley Hospital for Children; American Family Children's Hospital; Norton Children's Hospital
• Investigators: Principal Investigator: Shawn D St. Peter, MD, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimated): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: inguinal hernia; PPV; patent processus vaginalis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hernia; Hernia, Inguinal; Testicular Hydrocele
• Other Study ID Numbers: 16020156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data coordination site will have contact information for all subjects so that long-term follow-up can be done. Each contributing site will only have access to their own subjects' information.
• IPD Sharing Time Frame: duration of study
• IPD Sharing Access Criteria: REDCap
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE