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Clinical study on the treatment of pediatric defecation disorder based on biomechatronics

Clinical study on the treatment of pediatric defecation disorder based on biomechatronics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062752
Enrollment
Unknown
Registered
2022-08-18
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

pediatric defecation disorder

Interventions

1:biofeedback
2:Electrical stimulation
3:Biofeedback electric stimulation therapy

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Age 6-18 years old (female or male); 2. Screening patients with functional constipation according to Rome IV standard (1). It must include the following 2 or more items, and the symptoms shall be at least once a week for at least 1 month. 1) Defecate twice a week or less; 2) Fecal incontinence at least once a week; 3) Have a history of passive posture or excessive tolerance of fecal retention; 4) Have a history of pain in defecation or draining hard feces; 5) There is a large mass of feces in the rectum; 6) Have a history of discharging coarse feces, and even cause toilet blockage; 7) After moderate evaluation, the symptoms cannot be completely explained by other disease conditions. (2) Laxatives are rarely used. (3) It does not meet the diagnostic criteria of irritable bowel syndrome. 3. STC, DD, mixed constipation were confirmed by colon transit test (CTT) and defecography; 4. Agree to abide by all conditions of the study in good faith and participate in all necessary learning, training and evaluation; 5. Informed consent must be provided and signed prior to any study related procedures.

Exclusion criteria

Exclusion criteria: 1. Those who do not meet any of the above inclusion conditions; 2. Patients with colorectal organic diseases, such as colorectal space occupying and inflammation, were excluded by barium enema, defecography, electronic colonoscopy and other imaging methods; 3. Other serious systemic chronic diseases, such as cardiopulmonary, liver and kidney insufficiency, hematological diseases, hypothyroidism or hyperthyroidism, and systemic connective tissue diseases, were excluded by asking medical history, physical examination and routine blood physiological examination; 4. People with abnormal mental functions such as depression, anxiety and irritability, as well as patients with hemiplegia, spinal cord injury, mental retardation and other uncooperative patients; 5. Previous abdominal and pelvic surgery; 6. Pregnant or lactating; 7. Patients with other anorectal diseases or symptoms, such as hemorrhoids, severe pain around the anus and other diseases.

Design outcomes

Primary

MeasureTime frame
colon transit time;Anorectal manometry;Defecography;

Secondary

MeasureTime frame
Pelvic floor electromyography;

Countries

China

Contacts

Public ContactDaqing Sun

Tianjin Medical University General Hospital

sundaqingchris@126.com+86 18222889141

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026