Constipation - Functional, Gastrointestinal Motility Disorders in Children, Hirschsprung Disease
Conditions
Keywords
pediatric gastrointestinal motility disorders, chronic constipation, Hirschsprung disease, sacral neuromodulation
Brief summary
The goal of this study is to learn about the effects of sacral neuromodulation in pediatric patients with gastrointestinal motility disorders. By combining advanced neuroimaging, patient-specific biophysical modeling, electrophysiological characterization, and clinical translation, the SMART-GUT project establishes a comprehensive framework to systematically investigate neuromodulation in this pediatric population. This integrative approach enables a direct link between mechanism, targeting, and clinical outcome.
Detailed description
Patients enrolled in the study will be receiving sacral neuromodulation (via surgical implantation) and MRIs prior to neuromodulation treatment and after 12 weeks. In cases of surgical implantation, the intraoperative testing is accompanied by a broad neuronal evaluation (The goal is to establish with these informations * improved understanding of interindividual sacral nerval anatomy * improved guidelines for implantation of sacral neuromodulation via 3D reconstructions (digital twins) * prediction of neural activation by sacral neuromodulation and improvement of response rates * mechanism guided implantation based on clinical symptoms (fecal incontinence vs. leading constipative symptoms) * improvement of therapeutic efficacy in comparison to non-guided implantation
Interventions
PROCEDURESNM/MRI/EMG
Participants are receiving clinical baseline evaluation, preoperative sacral and functional MRI, reconstruction of digital twin, surgical implantation of sacral neuromodulation including intraoperative testing, postoperative sacral and functional MRI, and clinical follow-up
Sponsors
Friedrich-Alexander-Universität Erlangen-Nürnberg
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* informed consent of patient and care taker * gastrointestinal motility disorder, disregarding underlying diseases * exclusion of mechanical obstructions in the gastrointestinal passage * age between 3 and 18
Exclusion criteria
* pregnancy/breast feeding * decreased renal or thyroidal function * drug intake of Beta-blockers, antispasmodics, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin * contradictions for MRI * indication for analgosedation for MRI * inflammatory bowel diseases * fractures/different anatomy in sacral region * epilepsy * presence of cardiac pacemakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal incontinence | Within 12 weeks of sacral neuromodulation | Changes in the frequency and intensity of fecal incontinence, assessed by specialized questionnaires for patients and parents and analyzed per day (scale \>1x/d; 1x/d; 2-3x/week; 1x/week; \<1x/week and classified as soiling/encopresis) |
| Abdominal pain | Within 12 weeks of sacral neuromodulation | Changes in the frequency and intensity of abdominal pain, , assessed by specialized questionnaires for patients and parents (NRS scale, 0 no pain - 10 maximum pain) and analyzed as episodes per day |
| Defecation frequency | Within 12 weeks of sacral neuromodulation | Changes in defecation frequency per week, assessed by specialized questionnaires for patients and parents (scale \>1x/d; 1x/d; 2-3x/week; 1x/week; \<1x/week and classified regarding consistency based on Bristol Stool Scale (1 hard stool - 7 fluid stool)) |
| Urinary incontinence | Within 12 weeks of sacral neuromodulation | Changes in frequency and intensity of urinary incontinence, assessed by specialized questionnaires for patients and parents and analyzed per day (scale \>1x/d; 1x/d; 2-3x/week; 1x/week; \<1x/week) |
| Proprioception | Within 12 weeks of sacral neuromodulation | Changes in the proprioception of urge to defecate, assessed by specialized questionnaires for patients and parents and analyzed per day (scale normal urge to defecate without soiling/encopresis; rare urge to defecate with soiling/encopresis; no urge to defecate with soiling/encopresis) |
Countries
Germany
Contacts
CONTACTSonja Diez, PD Dr. med.
Outcome results
None listed