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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01878500
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arm: 1
• Duration (Months): 100
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Exstrophy	Device: Intraoperative stereotactic imaging with VectorVision	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Navigation of the Pelvic Floor in Bladder Exstrophy Using Pre-operative MRI
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Intraoperative stereotactic imaging 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; 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.; Other Names: VectorVision® Cranial Guided Image System by Brainlab Inc.

Outcome Measures

Primary Outcome Measures

1. Success or Failure of Exstrophy Closure [2 years]

   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

1. Urinary Continence [2 years]

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

2. Operative Time [Intraoperatively]

   Time (measured in minutes) of operation.

3. Length of Hospital Stay [Up to 2 months]

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

4. Peri-operative Complications as Assessed by the Total Number of Transfusions [Intraoperatively]

   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.

5. Subjective Improved Identification of the Pelvic Floor Anatomy During Bladder Exstrophy Closure as Reported by the Surgeon [Intraoperatively]

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

6. Total Number of Post-operative Complications [2 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brady Urological Institute. Johns Hopkins University	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: John P Gearhart, MD, Brady Urological Institute, Department of Pediatric Urology

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 2, 2012

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01878500
• Other Study ID Numbers: NA_00069579
• First Posted: Jun 17, 2013
• Last Update Posted: Dec 21, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Johns Hopkins University: Bladder exstrophy epispadias complex; Pelvic floor musculature; Intraoperative stereotactic imaging
• Additional relevant MeSH terms: Bladder Exstrophy

Study Results

Participant Flow

Pre-assignment Detail	All patients with bladder exstrophy were recruited. Those who were undergoing exstrophy closure with pelvic osteotomy were included. Those who did not have planned pelvic osteotomy prior to closure were excluded (1).

Arm/Group Title	Intraoperative Stereotactic Imaging
Arm/Group Description	Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: 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.
Period Title: Overall Study
STARTED	47
COMPLETED	47
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Intraoperative Stereotactic Imaging
Arm/Group Description	Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: 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.
Overall Participants	47
Age (Count of Participants)
<=18 years	47 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (weeks) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [weeks]	28.6
Sex: Female, Male (Count of Participants)
Female	20 42.6%
Male	27 57.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	47 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Arm/Group Title	Intraoperative Stereotactic Imaging
Arm/Group Description	Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: 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.
Measure Participants	44
Successful	44
Failed	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data was not collected.

Arm/Group Title	Intraoperative Stereotactic Imaging
Arm/Group Description	Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: 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.
Measure Participants	0

3. Secondary Outcome

Title	Operative Time
Description	Time (measured in minutes) of operation.
Time Frame	Intraoperatively

Outcome Measure Data

Analysis Population Description

3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Arm/Group Title	Intraoperative Stereotactic Imaging
Arm/Group Description	Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: 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.
Measure Participants	44
Median (Inter-Quartile Range) [minutes]	619

4. Secondary Outcome

Title	Length of Hospital Stay
Description	Length of hospital stay (in days) for each participant.
Time Frame	Up to 2 months

Outcome Measure Data

Analysis Population Description

3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Arm/Group Title	Intraoperative Stereotactic Imaging
Arm/Group Description	Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: 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.
Measure Participants	44
Median (Inter-Quartile Range) [days]	50

5. Secondary Outcome

Title	Peri-operative Complications as Assessed by the Total Number of Transfusions
Description	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.
Time Frame	Intraoperatively

Outcome Measure Data

Analysis Population Description

3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Arm/Group Title	Intraoperative Stereotactic Imaging
Arm/Group Description	Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: 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.
Measure Participants	44
Number [transfusions]	26

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Arm/Group Title	Intraoperative Stereotactic Imaging
Arm/Group Description	Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: 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.
Measure Participants	44
Yes	44 93.6%
No	0 0%

7. Secondary Outcome

Title	Total Number of Post-operative Complications
Description	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.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Arm/Group Title	Intraoperative Stereotactic Imaging
Arm/Group Description	Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: 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.
Measure Participants	44
Overall complications	10
Grade I	3
Grade II	3
Grade IIIb	4

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	Complications were graded on the Clavien-Dindo Classification Scheme to stratify minor from major complications. 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.
Arm/Group Title	Intraoperative Stereotactic Imaging
Arm/Group Description	Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: 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.
All Cause Mortality
	Intraoperative Stereotactic Imaging
	Affected / at Risk (%)	# Events
Total	0/44 (0%)
Serious Adverse Events
	Intraoperative Stereotactic Imaging
	Affected / at Risk (%)	# Events
Total	0/44 (0%)
Other (Not Including Serious) Adverse Events
	Intraoperative Stereotactic Imaging
	Affected / at Risk (%)	# Events
Total	10/44 (22.7%)
Infections and infestations
Wound infection	4/44 (9.1%)	4
Pin site infection	1/44 (2.3%)	1
Renal and urinary disorders
Acute Kidney Injury	2/44 (4.5%)	2
Urine leak	1/44 (2.3%)	1
Ureteral obstruction	1/44 (2.3%)	1
Skin and subcutaneous tissue disorders
Wound Dehiscence	1/44 (2.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.