Status:
COMPLETED
Sacral Neuromodulation in Children and Adolescents
Lead Sponsor:
Friedrich-Alexander-Universität Erlangen-Nürnberg
Conditions:
Chronic Constipation With Overflow
Encopresis With Constipation and Overflow Incontinence
Eligibility:
All Genders
2-17 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy of neuromodulation for treatment of chronic constipation and fecal incontinence in pediatric patients and to evaluate the differences between the in...
Detailed Description
Patients are selected according to the eligibility requirements. After obtaining informed consent off-label use and potential risks of sacral neuromodulation, all included patients and next of kin giv...
Eligibility Criteria
Inclusion
- age between 2-17 years
- informed consent
- chronic constipation according to the ROME IV criteria for more than 3 months with or without encopresis/soiling despite underlying diseases such as slow-transit constipation, rectal evacuation disorders or Hirschsprung's disease.
- refractory to conventional treatment in an appropriate weight-adapted application (training for bowel movements, lifestyle changes, pelvic floor training, pharmacological options)
- in cases of Hirschsprung's disease: diagnosis confirmed histologically by rectal biopsies and in case of resection of an aganglionic segement: period between surgery and SNM at least 1 year
- in cases of anorectal malformation or mechanical obstruction: post-surgical status: period between surgery and SNM at least 1 year
Exclusion
- metabolic, inflammatory, and hormonal causes for chronic constipation
- toxic megacolon or further emergencies, which must be treated surgically
- sacral fractures or substantial differences in the sacral anatomy
- inflammatory bowel disorders
- rectal prolapse
- neuronal malignancies under medical and radiation therapy
- seizures
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04713085
Start Date
January 1 2019
End Date
December 31 2024
Last Update
September 8 2025
Active Locations (1)
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1
Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
Erlangen, Bavaria, Germany, 91054