Anorectal Malformations Clinical Trial
Official title:
Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation: a Case-control Study on External Neuromodulatory Treatment
Verified date | December 2022 |
Source | Friedrich-Alexander-Universität Erlangen-Nürnberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the efficacy of additional neuromodulation for treatment of chronic constipation in pediatric patients
Status | Completed |
Enrollment | 59 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility | Inclusion Criteria: - 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 - refractory to conventional treatment in a sufficient application (training for bowel movements, lifestyle changes, pelvic floor training) - exclusion of metabolic, inflammatory and hormonal causes for chronic constipation (such as e.g., celiac disease, cystic fibrosis, hypothyroidism) - in cases of underlying Hirschsprung's disease: confirmation of diagnosis via rectal biopsies - in cases of anorectal malformation: post-surgical status Exclusion Criteria: - metabolic, inflammatory and hormonal causes for chronic constipation with further therapeutic options - toxic megacolon or further emergencies, which must be treated surgically - fractures or substantial differences in the sacral anatomy - inflammatory bowel disorders - rectal prolapse - neuronal malignancies under medical and radiation therapy - seizures |
Country | Name | City | State |
---|---|---|---|
Germany | Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery | Erlangen | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Friedrich-Alexander-Universität Erlangen-Nürnberg |
Germany,
Besendorfer M, Kohl M, Schellerer V, Carbon R, Diez S. A Pilot Study of Non-invasive Sacral Nerve Stimulation in Treatment of Constipation in Childhood and Adolescence. Front Pediatr. 2020 Apr 16;8:169. doi: 10.3389/fped.2020.00169. eCollection 2020. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptoms: Change in defecation frequency | Defecation frequency is measured by bowel movements per week. | Baseline and 12 weeks after start of therapy | |
Primary | Symptoms: Change in defecation consistency | Defecation consistency is measured by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency). | Baseline and 12 weeks after start of therapy | |
Primary | Symptoms: Change of encopresis/soiling | Episodes of encopresis/soiling are evaluated per day. | Baseline and 12 weeks after start of therapy | |
Primary | Change in Quality of Life | The quality of life is classified via the 'Revised Children's Quality of Life Questionnaire' (KINDLR). It consists of 24 5-point Likert-scale items, covering 6 quality of life dimensions: physical well-being, emotional well-being, self-esteem, family, friends and daily functioning (school or nursery school/kindergarten). Items are partially reverse scored and linearly transformed to a 0 to 100 scale according to the manual. Higher scores indicate a better quality of life. | Baseline and 12 weeks after start of therapy | |
Secondary | Symptoms: Change of abdominal pain | Abdominal pain is recorded in episodes per week and its intensity is evaluated via the numeric rating scale (0=no pain, 10=worst imaginable pain) | Baseline and 12 weeks after start of therapy |
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