N/A
N=47
Navigation of the Pelvic Floor in Bladder Exstrophy Using Pre-operative MRI
Bladder Exstrophy
Bottom Line
View on ClinicalTrials.gov: NCT01878500 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Success or Failure of Exstrophy Closure — 44; 0 exstrophy closures
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intraoperative stereotactic imaging with VectorVision (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success or Failure of Exstrophy Closure |
44; 0 | — |
| SECONDARY Urinary Continence |
— | — |
| SECONDARY Operative Time |
619 | — |
| SECONDARY Length of Hospital Stay |
50 | — |
| SECONDARY Peri-operative Complications as Assessed by the Total Number of Transfusions |
26 | — |
| SECONDARY Subjective Improved Identification of the Pelvic Floor Anatomy During Bladder Exstrophy Closure as Reported by the Surgeon |
44; 0 | — |
| SECONDARY Total Number of Post-operative Complications |
10; 3; 3; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01878500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.