Sacrococcygeal TeratomaTSC-URONCT05182853
Voiding Disorders in Children After Sacrococcygeal Teratoma Resection
An observational study of Sacrococcygeal Teratoma and Neurogenic Bladder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Sacrococcygeal Teratoma, Neurogenic Bladder, Voiding Disorders
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who underwent surgical treatment of a sacrococcygeal teratoma, without ano rectal malformation or any other neurological pathology
Who may be able to join
- Children aged 6 to 18
- history of sacrococcygeal teratoma resection
Who cannot join
- Associated anorectal malformation
- Associated neurological pathology
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Keywords
- Teratoma, sacrococcygeal region, urinary incontinence, neurogenic bladder, children
- Medical subject headings
- Urinary Bladder, Neurogenic, Teratoma, Urinary Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of voiding disorders
Presence of voiding disorders will be assessed by the scale: Dysfonctional voiding scoring system
Measured: Day 1
Secondary outcomes (2)
Presence of defecation disorders
The Presence of defecation disorders will be assessed by the scale: Bristol stool scale
Measured: Day 1
Presence of secondary neurological bladder
the Presence of secondary neurological bladder will be assessed by the uroflowmetry
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start16 Jun 2021
- Primary completion30 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacrococcygeal TeratomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah GARNIER, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182853
- Sponsor's protocol ID
- RECHMPL21_0377
- Acronym
- TSC-URO
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voiding Disorders in Children After Sacrococcygeal Teratoma Resection
- ClinicalTrials.gov ID
- NCT05182853
- Acronym / sponsor ID
- TSC-URO / RECHMPL21_0377
- Keywords
- Teratoma, sacrococcygeal region, urinary incontinence, neurogenic bladder, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who underwent surgical treatment of a sacrococcygeal teratoma, without ano rectal malformation or any other neurological pathology
Key inclusion criteria (2 listed)
- Children aged 6 to 18
- history of sacrococcygeal teratoma resection
Key exclusion criteria (2 listed)
- Associated anorectal malformation
- Associated neurological pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of voiding disorders
Time frame: Day 1
Presence of voiding disorders will be assessed by the scale: Dysfonctional voiding scoring system
2 secondary outcomes
Presence of defecation disorders
Time frame: Day 1
Presence of secondary neurological bladder
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Undecided. NC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah GARNIER principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacrococcygeal Teratoma and Neurogenic Bladder, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of voiding disorders (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.