Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03042858 |
| Other study ID # |
16020156 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2017 |
| Est. completion date |
December 2036 |
Study information
| Verified date |
April 2024 |
| Source |
Children's Mercy Hospital Kansas City |
| Contact |
Shawn D St. Peter, MD |
| Phone |
816-234-3575 |
| Email |
sspeter[@]cmh.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
