Clinical trial NCT01878500: Navigation of the Pelvic Floor in Bladder Exstrophy Using Pre-operative MRI
Official title: Navigation of the Pelvic Floor in Bladder Exstrophy Using Pre-operative MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Exstrophy
Keywords: Bladder exstrophy epispadias complex
Pelvic floor musculature
Intraoperative stereotactic imaging
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 48
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 of the pelvic floor so that the bladder can be placed in the most posterior and inferior position possible. Oftentimes, the need for repeat closure of the abdomen is required if the initial surgeon failed to properly dissect deep enough into the child's pelvic floor. Many surgeons are unfamiliar with the complex anatomy and are unable to verify that they have properly reached the true pelvic floor during this initial surgery. This often leads to failed closures, which result in poor continence rates later in life.

The investigators are attempting to determine the safety and efficacy of the use the Brainlab, Inc. VisionVector® Cranial Image Guided Surgery System during closure of bladder exstrophy. The value of this research is two-fold. Firstly, the project will help us to verify if the investigators are indeed dissecting down to the proper plane required for successful initial closure of bladder exstrophy. Secondly, this project will help others with relatively less experience with bladder exstrophy to properly identify where they are anatomically during closure of exstrophy, thus yielding higher success rates and better patient care at other centers.

Eligibility criteria: Inclusion Criteria:

1. Age 0-7 years
2. Diagnosis of classic bladder exstrophy
3. Scheduled to undergo bladder exstrophy closure by the principal investigator at Johns Hopkins Hospital's Broadway campus.
4. 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.
5. 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.
6. Parent or legally authorized representative is able to complete and sign the informed consent document.
7. 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 \[16\].
8. 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.
9. Patients requiring ferromagnetic metal objects such as a metal pace maker during the OR procedure.

Exclusion Criteria:

1. Lack or withdrawal of consent for primary operative procedure.
2. 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.
3. 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.
4. Patient who will not undergo osteotomy prior to closure for any reason

Primary outcomes:
measure: Success or Failure of Exstrophy Closure
timeFrame: 2 years
Secondary outcomes:
measure: Urinary Continence
timeFrame: 2 years
measure: Operative Time
timeFrame: Intraoperatively
measure: Length of Hospital Stay
timeFrame: Up to 2 months
measure: Peri-operative Complications as Assessed by the Total Number of Transfusions
timeFrame: Intraoperatively
measure: Subjective Improved Identification of the Pelvic Floor Anatomy During Bladder Exstrophy Closure as Reported by the Surgeon
timeFrame: Intraoperatively
measure: Total Number of Post-operative Complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Brady Urological Institute. Johns Hopkins University
state: Maryland
Study officials:
affiliation: Brady Urological Institute, Department of Pediatric Urology
name: John P Gearhart, MD
role: PRINCIPAL_INVESTIGATOR
References: