Status:
COMPLETED
Navigation of the Pelvic Floor in Bladder Exstrophy Using Pre-operative MRI
Lead Sponsor:
Johns Hopkins University
Conditions:
Bladder Exstrophy
Eligibility:
All Genders
Up to 7 years
Phase:
NA
Brief Summary
The aim of this study is to investigate the use of intraoperative stereotactic imaging of the pelvic floor musculature during closure of bladder exstrophy.
Detailed Description
Much of the long-term success of classic bladder exstrophy closures depends on the initial closure. Several studies have demonstrated that a key to successful initial closure involves deep dissection ...
Eligibility Criteria
Inclusion
- Age 0-7 years
- Diagnosis of classic bladder exstrophy
- Scheduled to undergo bladder exstrophy closure by the principal investigator at Johns Hopkins Hospital's Broadway campus.
- All eligible participants will be children whose parents or legally authorized representatives have already agreed and are being scheduled for osteotomy and bladder exstrophy closure as determined by their pediatric urologist.
- Parent or legally authorized representative who is, in the opinion of the investigator, reliable and willing to make themselves and patient available for the duration of the study.
- Parent or legally authorized representative is able to complete and sign the informed consent document.
- Patient judged by the investigator to have bladders of sufficient size and elasticity to be suitable for immediate closure as evidenced by the PI's assessment of the patient's bladder template \[16\].
- Patient with cardiopulmonary function sufficient to tolerate general anesthesia as evidenced by the pediatrician's and anesthesiologists assessment of the patient's overall cardio-pulmonary status.
- Patients requiring ferromagnetic metal objects such as a metal pace maker during the OR procedure.
Exclusion
- Lack or withdrawal of consent for primary operative procedure.
- Parent or legally authorized representative who is, in the opinion of the investigator, not reliable or unwilling to make themselves and patient available for the duration of the study.
- Parent or legally authorized representative who is unable to understand, complete and/or sign the informed consent document. Non-English speaking parents will automatically be excluded if they are unable to read and understand the consent form.
- Patient who will not undergo osteotomy prior to closure for any reason
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01878500
Start Date
September 1 2012
End Date
December 31 2020
Last Update
December 21 2021
Active Locations (1)
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1
Brady Urological Institute. Johns Hopkins University
Baltimore, Maryland, United States, 21287