NCT04580186

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

October 2, 2020

Last Update Submit

April 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate results of the technique used for bladder exstrophy repair

    complete bladder exstrophy repair

    base line

Secondary Outcomes (1)

  • Present recent development in care and repair of these patients

    baseline

Interventions

primary complete bladder exstrophy repair

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

: patients with bladder exstrophy attending assiut university urology hospital

You may qualify if:

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

You may not qualify if:

  • Cloacal exstrophy isolated epispadias previous failed repair out Assiut university hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 21944104BACKGROUND
  • Mayo C, Hendricks W. Exstrophy of the bladder. Surg Gynecol Obstet. 1926;43:129-34.

    BACKGROUND
  • Jeffs RD. Functional closure of bladder exstrophy. Birth Defects Orig Artic Ser. 1977;13(5):171-3. No abstract available.

    PMID: 588684BACKGROUND
  • Chan DY, Jeffs RD, Gearhart JP. Determinants of continence in the bladder exstrophy population: predictors of success? Urology. 2001 Apr;57(4):774-7. doi: 10.1016/s0090-4295(00)01102-x.

    PMID: 11306402BACKGROUND
  • 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.

    PMID: 19906564BACKGROUND

MeSH Terms

Conditions

Bladder Exstrophy

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

mohamed emad eldin, master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 8, 2020

Study Start

May 15, 2021

Primary Completion

September 30, 2022

Study Completion

December 30, 2022

Last Updated

April 27, 2021

Record last verified: 2021-04