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NCT05182853: TSC-URO

Voiding Disorders in Children After Sacrococcygeal Teratoma Resection

Completed Last updated 11 January 2022
What this trial tests

trial in Sacrococcygeal Teratoma in 8 participants. Completed in 1 December 2021.

Timeline
16 June 2021
Primary endpoint
30 September 2021
1 December 2021

Quick facts

Lead sponsorUniversity Hospital, Montpellier
StatusCompleted
Study typeOBSERVATIONAL
Enrollment8
Start date16 June 2021
Primary completion30 September 2021
Estimated completion1 December 2021
Sites1 location across France

Conditions studied

Sponsor

University Hospital, Montpellier

Who can join

Adults 6 to 18, any sex, with Sacrococcygeal Teratoma or Neurogenic Bladder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Trials by the same sponsor.

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Data sources for this page

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