ong term functional outcome, quality of life, and genetic factors in patients with a cloacal malformatio

• Conditions: congenital fusion of rectum; urogenital sinus with a rectovaginal fistula; vagina and urethra; 10018018; 10018188; 10017998

• Registration Number: NL-OMON39349
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Patiënt is born with a cloacal malformation
Patiënt is born after 1984 and before 2006

Exclusion Criteria

Patient is lost in follow-up

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome of the study are the scores from the completed questionnaires,<br /><br>the results from the urologic tests, the results from the gynecological consult<br /><br>and the MRI-study, laboratory results from urine and blood samples, and the<br /><br>results from the genetic tests.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The results from the questionnaires indicate colorectal function, urological<br /><br>function, gynecological function and sexual functioning. The two days voiding<br /><br>chart diary and the results from the urological tests both indicate bladder<br /><br>function. Laboratory results show the presence of any (chronic) inflammation of<br /><br>the urinary tract. Gynecological consult outcome as well as results from the<br /><br>MRI study will indicate gynecological and sexual function and will give<br /><br>information about fertility status. Laboratory results from the blood sample<br /><br>tests will indicate renal function. Genetic test results will show any genetic<br /><br>mutations that may play a role in the origination as well as the inheritability<br /><br>of cloacal malformations.</p><br>