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The aim of this study is to investigate the use of intraoperative stereotactic imaging of the pelvic floor musculature during closure of bladder exstrophy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Continence | Continence rates as determined by total dry time during the day, number of incontinent episodes, and need for dry pads. | 2 years |
| Operative Time | Time (measured in minutes) of operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Gearhart, MD | Brady Urological Institute, Department of Pediatric Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brady Urological Institute. Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis. | Posted | Number | exstrophy closures | 2 years |
|
2 years
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Dehiscence | Skin and subcutaneous tissue disorders | Clavien-Dindo Classi | Systematic Assessment | Wound Dehiscence, breakdown |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John P Gearhart | Johns Hopkins University | 410-955-5358 | jgearha2@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2012 | Nov 22, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001746 | Bladder Exstrophy |
| C564009 | Bladder Exstrophy and Epispadias Complex |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
|
| Intraoperatively |
| Length of Hospital Stay | Length of hospital stay (in days) for each participant. | Up to 2 months |
| 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. | Intraoperatively |
| 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' | Intraoperatively |
| 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. | 2 years |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | All patients referred to Johns Hopkins for bladder exstrophy were enrolled at Johns Hopkins in Baltimore, MD. | Count of Participants | Participants |
|
|
|
| Secondary | Urinary Continence | Continence rates as determined by total dry time during the day, number of incontinent episodes, and need for dry pads. | Data was not collected. | Posted | 2 years |
|
|
| Secondary | Operative Time | Time (measured in minutes) of operation. | 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis. | Posted | Median | Inter-Quartile Range | minutes | Intraoperatively |
|
|
|
| Secondary | Length of Hospital Stay | Length of hospital stay (in days) for each participant. | 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis. | Posted | Median | Inter-Quartile Range | days | Up to 2 months |
|
|
|
| Secondary | 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. | 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis. | Posted | Number | transfusions | Intraoperatively |
|
|
|
| Secondary | 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' | 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis. | Posted | Count of Participants | Participants | Intraoperatively |
|
|
|
| Secondary | 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. | 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis. | Posted | Number | Post-operative complications | 2 years |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 10 |
| 44 |
|
| Acute Kidney Injury | Renal and urinary disorders | Clavien-Dindo Classi | Systematic Assessment | Acute renal injury as determined by rise in Cr, drop-off in urine output |
|
| Wound infection | Infections and infestations | Clavien-Dindo Classi | Systematic Assessment | Infected surgical site |
|
| Pin site infection | Infections and infestations | Clavien-Dindo Classi | Systematic Assessment |
|
| Urine leak | Renal and urinary disorders | Clavien-Dindo Classi | Systematic Assessment |
|
| Ureteral obstruction | Renal and urinary disorders | Clavien-Dindo Classi | Systematic Assessment |
|
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| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Title | Measurements |
|---|---|
|
| Grade IIIb |
|