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N/A Completed N=47 Treatment

Navigation of the Pelvic Floor in Bladder Exstrophy Using Pre-operative MRI

Bladder Exstrophy
Source: ClinicalTrials.gov NCT01878500 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Success or Failure of Exstrophy Closure — 44; 0 exstrophy closures

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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