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Use of Ankle Electrical Stimulation for the treatment of children and adolescents who were born with diseases of the anus and intestine and after corrective surgery who present with intestinal constipation

Clinical evaluation and applicability of posterior tibial nerve transcutaneous electrical stimulation for the treatment of postoperative constipation in children and adolescents with Anorectal Malformation or Hirschsprung Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-98ymxqj
Enrollment
Unknown
Registered
2022-07-27
Start date
2021-09-18
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Interventions

This is a descriptive clinical cohort intervention study. with data collection scheduled for a period of 12 months, which seeks to evaluate the effectiveness and applicability of transcutaneous electr
E02.331.800

Sponsors

Faculdade de Medicina de Botucatu - Universidade Estadual Paulista
Lead Sponsor
Faculdade de Medicina de Botucatu - Universidade Estadual Paulista
Collaborator

Eligibility

Age
7 Years to 18 Years

Inclusion criteria

Inclusion criteria: Age between 7 and 18 years; Both sex; diagnosis of postoperative constipation according to Rome IV criteria; patient in late postoperative correction of anorectal malformations; patient in the late postoperative period of Hirschsprung's disease; Free and informed consent form and Free and informed consent form (patients between 11 and 18 years old) duly signed

Exclusion criteria

Exclusion criteria: Patients with ostomies; Patients with postoperative strictures; Patients with residual aganglionic follow-up; Neurological and/or cognitive deficits; Skin lesions at the application site; heart diseases; Subjected to medication or food change during the intervention; Patients who drop out of the intervention

Design outcomes

Primary

MeasureTime frame
It is expected to find the increase in the number of evacuations per week verified through the evacuation diary and the Bowel Function Score - BF-S quetinary, which will be completed before and after the intervention period;It is expected to find a reduction in the number of fecal losses, fecal incontinence, evaluated through the evacuation diary and the Bowel Function Score - BF-S quetinary, which will be completed before and after the intervention period;Improvement of stool consistency is expected, verified through the Modified Bristol Scale for Stool Consistency for children - mBSFS-C, which will be completed before and after the intervention period;Improvement of health-related quality of life indicators is expected, verified through the Pediatric Quality of Life Inventory version 4.0 - PedsQL 4.0 adapted for each age group, and the Questionnaire for Assessment of Quality of Life in Children and Adolescents with Fecal Incontinence - AQLCAFI that will be completed before and after the intervention period

Secondary

MeasureTime frame
We will evaluate the practical difficulties for the application of this method and possible adverse events through the questionnaire directed to the evaluation of the daily applicability in the home regime

Countries

Brazil

Contacts

Public ContactAna Luiza De Onofre

Faculdade de Medicina de Botucatu - Universidade Estadual Paulista

analuizardeonofre@gmail.com+55(14)38801703

Outcome results

None listed

Source: REBEC (via WHO ICTRP)