Outcome Of Classic Bladder Exstrophy Repair, Assiut University Experience

April 26, 2021 updated by: Mohamed Emad Eldin Anwar, Assiut University
  1. To review surgical and medical outcomes of the previous repaired bladder exstrophy cases.
  2. To present recent developments in surgical techniques and care of these patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

: patients with bladder exstrophy attending assiut university urology hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 15, 2021

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (ACTUAL)

October 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bladder extrophy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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