NCT06717386

Brief Summary

The study focuses on the surgical treatment of bladder exstrophy, a congenital condition where the bladder is located outside the body. It examines the use of modified diagonal pelvic osteotomy combined with an external fixator as a treatment approach. This method aims to improve pelvic support and facilitate proper bladder reconstruction. The study likely evaluates the outcomes, complications, and overall effectiveness of this surgical technique in enhancing patient quality of life and functional results. Key findings may include insights into recovery times, rates of successful bladder closure, and potential long-term benefits for patients.

Trial Health

43
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 not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

December 2, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2026

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

November 27, 2024

Last Update Submit

December 3, 2024

Conditions

Bladder Exstrophy

Outcome Measures

Primary Outcomes (1)

  • symphyseal diastaisis

    radiological

    1 year

Study Arms (2)

bladder epithpidius complex

OTHER

diagonal pelvic osteotomy in bladder exstrophy

Procedure: diagonal pelvic osteotomy

bladder exstrophy

OTHER

horizontal pelvic osteotomy

Procedure: diagonal pelvic osteotomy

Interventions

diagonal pelvic osteotomyPROCEDURE

supraacetabular pelvic osteotomy in oblique shape

bladder epithpidius complexbladder exstrophy

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age: all cases of delayed exstrophy repaior
  • sex : both gender
  • children who received no operative treatment befor

You may not qualify if:

  • previous pelvic surgery
  • sever comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

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

Ali abdel aal Bakheet, assistant lecturer

CONTACT

02001010505552ali.mohamed@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 5, 2024

Study Start

December 2, 2024

Primary Completion

December 2, 2025

Study Completion

February 2, 2026

Last Updated

December 5, 2024

Record last verified: 2024-12

Locations

EG(1)