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

NCT01878500 | Completed Results DMC

• 1 other identifier: NA_00069579
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Exstrophy

Keywords

Bladder exstrophy epispadias complex; Pelvic floor musculature; Intraoperative stereotactic imaging

Outcome Measures

Primary Outcomes (1)

• Success or Failure of Exstrophy Closure

  A failed bladder closure was defined as bladder prolapse, dehiscence, outlet obstruction, persistent vesicourethral fistula, or a combination of these, or a complication that required repeat closure.

  2 years

Secondary Outcomes (6)

• Urinary Continence

  2 years

• Operative Time

  Intraoperatively

• Length of Hospital Stay

  Up to 2 months

• Peri-operative Complications as Assessed by the Total Number of Transfusions

  Intraoperatively

• Subjective Improved Identification of the Pelvic Floor Anatomy During Bladder Exstrophy Closure as Reported by the Surgeon

  Intraoperatively

Study Arms (1)

Intraoperative stereotactic imaging

EXPERIMENTAL

Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure.

Device: Intraoperative stereotactic imaging with VectorVision

Interventions

Intraoperative stereotactic imaging with VectorVision DEVICE

Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.

Also known as: VectorVision® Cranial Guided Image System by Brainlab Inc.

Intraoperative stereotactic imaging

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Brady Urological Institute. Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Bladder Exstrophy; Bladder Exstrophy and Epispadias Complex

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. John P Gearhart
• Organization: Johns Hopkins University

jgearha2@jhmi.edu

410-955-5358

Study Officials

• John P Gearhart, MD

  Brady Urological Institute, Department of Pediatric Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 17, 2013
• Study Start: September 1, 2012
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 21, 2021
• Results First Posted: December 21, 2021

Record last verified: 2021-11

Locations

US (1)