Outcome Of Classic Bladder Exstrophy Repair, Assiut Unive... | NCT04580186

Studies
Outcome Of Classic Bladder Exstrophy Repair, Assiut University Experience

NCT04580186

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 27, 2021Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Bladder Exstrophy

Interventions

bladder exstrophy repair

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2021Estimated

Primary Completion Date

Sep 30, 2022Estimated

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Oct 2, 2020

First Submission Date that Met QC Criteria

Oct 2, 2020

First Posted Date

Oct 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2021

Last Update Posted Date

Apr 27, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Emad Eldin Anwar, assistant lecturer, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To review surgical and medical outcomes of the previous repaired bladder exstrophy cases.
To present recent developments in surgical techniques and care of these patients.

Detailed Description

Exstrophy-epispadias complex (EEC) is a spectrum of genitourinary malformations resulting from abnormal cloacal development .
CBE, the most common form with an incidence of 2.68 in 100,000 live births is characterized by an evaginated bladder plate, epispadias and an anterior defect of the pelvis, pelvic floor and abdominal wall
The single most important predictor of long-term bladder growth and continence is successful primary bladder closure .
The staged reconstruction of bladder exstrophy was proposed by Jeff and led to significant improvements in continence and renal function with excellent cosmetic results.
The initial staged management consisted of newborn bladder and posterior urethral closure followed by bladder neck reconstruction at 2 to 3 years of age and later epispadias repair.
The understanding that appropriately timed epispadias repair may lead to enhancement in bladder capacity led to performance of epispadias repair at 2 to 3 years of age followed by later bladder neck reconstruction. The current modification of the staged repair consists of secure bladder and posterior urethral closure in infancy followed by epispadias repair at 6 to 12 months of age and bladder neck reconstruction when the patient is able to cooperate in a good voiding program.
Complete repair surgery is performed in a single procedure that closes the bladder and the abdomen and repairs the urethra and outer sex organs
A failed classic bladder exstrophy (CBE) closure is defined by wound dehiscence, bladder prolapse, bladder outlet obstruction, or formation of a vesicocutaneous fistula.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bladder exstrophy repair	Procedure	primary complete bladder exstrophy repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate results of the technique used for bladder exstrophy repair	complete bladder exstrophy repair	base line

Secondary Outcomes

Measure	Description	Time Frame
Present recent development in care and repair of these patients	update in surgical technique	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All patient with CBE who underwent repair at Assiut university hospital.

Exclusion Criteria:

Cloacal exstrophy isolated epispadias previous failed repair out Assiut university hospital

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

: patients with bladder exstrophy attending assiut university urology hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mohamed emad eldin, master	Contact	01010685968		mohamed.emad@med.aun.edu.eg

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation
21944104	Background	Jayachandran D, Bythell M, Platt MW, Rankin J. Register based study of bladder exstrophy-epispadias complex: prevalence, associated anomalies, prenatal diagnosis and survival. J Urol. 2011 Nov;186(5):2056-60. doi: 10.1016/j.juro.2011.07.022. Epub 2011 Sep 25.
	Background	Mayo C, Hendricks W. Exstrophy of the bladder. Surg Gynecol Obstet. 1926;43:129-34.
588684

ID	Term
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases