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Voiding Disorders in Children After Sacrococcygeal Teratoma Resection

NCT ID: NCT05182853

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-16

Study Completion Date

2021-12-01

Brief Summary

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Sacrococcygeal teratomas are the most common neonatal tumors and require rapid and complete resection. Tumor nerve compression and pelvic surgical sequelae may lead to many and varied voiding disorders. Data concerning long-term vesico-sphincteric disorders are conflicting. Some studies find good functional results \[Cozzi et al., 2008; Draper et al., 2009\]. However other authors reveal neurologic bladder with detrusor sphincter dyssynergia \[Hambraeus et al., 2018\] and rise concerned about long-term renal function \[Khanna et al., 2019; Rehfuss et al., 2020\] even in the absence of clinical voiding disorders. Most of studies include young patients with other malformations such as anorectal malformations or dysraphisms which may impact the results. The main objective is to assess bladder dysfunction in children aged 6 to 18 years after isolated sacrococcygeal teratoma resection.

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Detailed Description

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Conditions

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Sacrococcygeal Teratoma Neurogenic Bladder Voiding Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Children aged 6 to 18
* history of sacrococcygeal teratoma resection

Exclusion Criteria

* Associated anorectal malformation
* Associated neurological pathology
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah GARNIER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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University hospital of Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL21_0377

Identifier Type: -

Identifier Source: org_study_id

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