Outcome Of Classic Bladder Exstrophy Repair, Assiut University Experience

Bladder Exstrophy Clinical Trial

Official title:

Outcome Of Classic Bladder Exstrophy Repair, Assiut University Experience

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04580186
• Other study ID #: bladder extrophy
• Status: Not yet recruiting
• Start date: May 15, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: mohamed emad eldin, master
• Phone: 01010685968
• Email: mohamed.emad[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Exstrophy

Intervention

Procedure:
• bladder exstrophy repair
primary complete bladder exstrophy repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

Chan DY, Jeffs RD, Gearhart JP. Determinants of continence in the bladder exstrophy population: predictors of success? Urology. 2001 Apr;57(4):774-7. — View Citation

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. — View Citation

Jeffs RD. Functional closure of bladder exstrophy. Birth Defects Orig Artic Ser. 1977;13(5):171-3. — View Citation

Mayo C, Hendricks W. Exstrophy of the bladder. Surg Gynecol Obstet. 1926;43:129-34.

Novak TE, Costello JP, Orosco R, Sponseller PD, Mack E, Gearhart JP. Failed exstrophy closure: management and outcome. J Pediatr Urol. 2010 Aug;6(4):381-4. doi: 10.1016/j.jpurol.2009.10.009. Epub 2009 Nov 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate results of the technique used for bladder exstrophy repair	complete bladder exstrophy repair	base line
Secondary	Present recent development in care and repair of these patients	update in surgical technique	baseline