Voiding Disorders in Children After Sacrococcygeal Teratoma Resection

NCT05182853 | Completed

• 1 other identifier: RECHMPL21_0377
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sacrococcygeal Teratoma; Neurogenic Bladder; Voiding Disorders

Keywords

Teratoma; sacrococcygeal region; urinary incontinence; neurogenic bladder; children

Outcome Measures

Primary Outcomes (1)

• Presence of voiding disorders

  Presence of voiding disorders will be assessed by the scale: Dysfonctional voiding scoring system

  Day 1

Secondary Outcomes (2)

• Presence of defecation disorders

  Day 1

• Presence of secondary neurological bladder

  Day 1

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent surgical treatment of a sacrococcygeal teratoma, without ano rectal malformation or any other neurological pathology

You may qualify if:

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

You may not qualify if:

• Associated anorectal malformation
• Associated neurological pathology

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Teratoma; Urinary Incontinence

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations

Study Officials

• Sarah GARNIER

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 10, 2022
• Study Start: June 16, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

FR (1)