Outcome Of Classic Bladder Exstrophy Repair, Assiut University Experience

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04580186
Collaborator
(none)
10
19.5

Study Details

Study Description

Brief Summary

  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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: bladder exstrophy repair

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
10 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Outcome Of Classic Bladder Exstrophy Repair, Assiut University Experience
Anticipated Study Start Date :
May 15, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Evaluate results of the technique used for bladder exstrophy repair [base line]

    complete bladder exstrophy repair

Secondary Outcome Measures

  1. Present recent development in care and repair of these patients [baseline]

    update in surgical technique

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Emad Eldin Anwar, assistant lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT04580186
Other Study ID Numbers:
  • bladder extrophy
First Posted:
Oct 8, 2020
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2021