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

Primary Purpose

Bladder Exstrophy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intraoperative stereotactic imaging with VectorVision

About this trial

This is an interventional treatment trial for Bladder Exstrophy focused on measuring Bladder exstrophy epispadias complex, Pelvic floor musculature, Intraoperative stereotactic imaging

Eligibility Criteria

undefined - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brady Urological Institute. Johns Hopkins University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative stereotactic imaging

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Urinary Continence

Continence rates as determined by total dry time during the day, number of incontinent episodes, and need for dry pads.

Operative Time

Time (measured in minutes) of operation.

Length of Hospital Stay

Length of hospital stay (in days) for each participant.

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

Peri-operative complications were those encountered immediately before, during, or immediately following the case, primarily regarding need for blood transfusions. Though these are not complications (and deemed necessary/inherent to the operation), they are tracked closely as an outcome measure.

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

Surgeon's were surveyed post-operatively on whether the intervention improved identification of pelvic floor anatomy. Measure: Binary, 'Yes' and 'No'

Total Number of Post-operative Complications

Post-operative complications were graded on the Clavien-Dindo Classification System. The Clavien-Dindo System is a standardized classification for reporting and registering complications. It grades the severity of a complication based on the therapy required to treat the complication. It is a tiered system with subdivided categories as follows: Grade I and II are considered minor, Grade III is considered moderate and Grades IV and V are severe complications.

Full Information

NCT ID

NCT01878500

First Posted

June 7, 2013

Last Updated

November 22, 2021

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT01878500

Brief Title

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

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Exstrophy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intraoperative stereotactic imaging

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Intraoperative stereotactic imaging with VectorVision

Other Intervention Name(s)

VectorVision® Cranial Guided Image System by Brainlab Inc.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Success or Failure of Exstrophy Closure

Description

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.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Urinary Continence

Description

Continence rates as determined by total dry time during the day, number of incontinent episodes, and need for dry pads.

Time Frame

2 years

Title

Operative Time

Description

Time (measured in minutes) of operation.

Time Frame

Intraoperatively

Title

Length of Hospital Stay

Description

Length of hospital stay (in days) for each participant.

Time Frame

Up to 2 months

Title

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

Description

Time Frame

Intraoperatively

Title

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

Description

Surgeon's were surveyed post-operatively on whether the intervention improved identification of pelvic floor anatomy. Measure: Binary, 'Yes' and 'No'

Time Frame

Intraoperatively

Title

Total Number of Post-operative Complications

Description

Time Frame

2 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John P Gearhart, MD

Organizational Affiliation

Brady Urological Institute, Department of Pediatric Urology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brady Urological Institute. Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

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

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