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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01878500

Enrollment

Registered

2013-06-17

Start date

2012-09-30

Completion date

2020-12-31

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Exstrophy

Keywords

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

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.

Interventions

DEVICEIntraoperative 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Operative Time	Intraoperatively	Time (measured in minutes) of operation.
Length of Hospital Stay	Up to 2 months	Length of hospital stay (in days) for each participant.
Urinary Continence	2 years	Continence rates as determined by total dry time during the day, number of incontinent episodes, and need for dry pads.
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'
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.
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.

Countries

United States

Participant flow

Pre-assignment details

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).

Participants by arm

Arm	Count
Intraoperative Stereotactic Imaging 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.	47
Total	47

Arm

Count

Intraoperative Stereotactic Imaging

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.

Total

Baseline characteristics

Characteristic	Intraoperative Stereotactic Imaging	—
Age, Categorical <=18 years	47 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	0 Participants	—
Age, Continuous	28.6 weeks	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	47 Participants	—
Sex: Female, Male Female	20 Participants	—
Sex: Female, Male Male	27 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 44
other Total, other adverse events	10 / 44
serious Total, serious adverse events	0 / 44

Outcome results

Primary

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.

Time frame: 2 years