Patent Processus VaginalisHxPPVNCT03042858
Natural History of Infants With Patent Processus Vaginalis
An observational study of Patent Processus Vaginalis and Inguinal Hernia, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 4 months
- Conditions the study is for
- Patent Processus Vaginalis, Inguinal Hernia
- What is being tested?
- Infants with PPV and Infants without PPV
- How many people
- 801 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 4 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants undergoing laparoscopic pyloromyotomy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
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.
Read the 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.
- Conditions
- Patent Processus Vaginalis, Inguinal Hernia
- Being tested
- Infants with PPV, Infants without PPV
- Keywords
- PPV, patent processus vaginalis, inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infants with PPVOther
Data will be collected for up to 18 years to monitor for inguinal hernia.
Infants without PPVOther
Basic data will be collected regarding the surgery and the subject's study participation will be complete.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Infants without PPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 years
Secondary outcomes (1)
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.
Measured: 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2035 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Processus VaginalisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital, C.S. Mott Children's Hospital, University of Chicago, James Whitcomb Riley Hospital for Children, American Family Children's Hospital, Children's Hospital and Health System Foundation, Wisconsin, Norton Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Shawn St. Peter, Children's Mercy Hospital Kansas City
- Investigators
- Shawn D St. Peter, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042858
- Sponsor's protocol ID
- 16020156
- Acronym
- HxPPV
- Status last verified
- Mar 2026
- First submitted
- 1 Feb 2017
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Infants With Patent Processus Vaginalis
- ClinicalTrials.gov ID
- NCT03042858
- Acronym / sponsor ID
- HxPPV / 16020156
- Conditions
- Patent Processus Vaginalis, Inguinal Hernia
- Keywords
- PPV, patent processus vaginalis, inguinal hernia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 801 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital, C.S. Mott Children's Hospital, University of Chicago, James Whitcomb Riley Hospital for Children, American Family Children's Hospital, Children's Hospital and Health System Foundation, Wisconsin, Norton Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- Jan 2017
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants with PPV | – | Other: Infants with PPVDuring 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 | – | Other: Infants without PPVDuring 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. |
Who may qualify
- Ages
- 1 day to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants undergoing laparoscopic pyloromyotomy.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infants with PPVData will be collected for up to 18 years to monitor for inguinal hernia. | Other | Infants with PPV |
| Infants without PPVBasic data will be collected regarding the surgery and the subject's study participation will be complete. | Other | Infants without PPV |
Primary outcome
Incidence of inguinal hernia
Time frame: 18 years
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
1 secondary outcome
Time to development of inguinal hernia
Time frame: 18 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn D St. Peter, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Processus Vaginalis and Inguinal Hernia, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of inguinal hernia (time frame: 18 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.