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The Effectiveness and Safty of Sacral Nerve Stimulation in Hirschsprung's Children with Postoperative Fecal Incontinence

The Effectiveness and Safty of Sacral Nerve Stimulation in Hirschsprung's Children with Postoperative Fecal Incontinence

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121578
Enrollment
Unknown
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

fecal incontinence after pull-through surgery for Hirschsprung's disease, defecation disorders

Interventions

Test group:Sacral nerve stimulation

Sponsors

Beijing Childrens Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. At least 6 months since the last colorectal surgery; 2. Average of >=2 days per week with soiling, or >=2 episodes of fecal incontinence per week; 3. Wexner score >4; 4. Failure of conservative treatment for 6 months; 5. Able to accurately maintain a bowel diary and complete relevant questionnaires; 6. Imaging findings must meet the following criteria: Pelvic MRI: intact pelvic floor and perianal muscles, or no significant defects; Anorectal manometry: resting anal canal pressure =40 ml/cm H2O (if concomitant voiding dysfunction is present); Lower gastrointestinal contrast study: no significant colorectal outlet obstruction.

Exclusion criteria

Exclusion criteria: 1. anatomical abnormalities at the distal colorectum or anus requiring surgical correction, such as rectal prolapse or colorectal anastomotic stricture; 2. Presence of known conditions affecting bowel function, including but not limited to: inflammatory bowel disease, hypothyroidism, infectious diarrhea, gastrointestinal malformations, etc; 3. Sphincter injury or defect involving >=160 degrees; 4. Concurrent anal diseases, including but not limited to: anal fistula, perianal abscess, anal fissure, etc; 5. Concurrent spinal cord or vertebral developmental abnormalities that preclude implantation based on preoperative CT reconstruction, such as severe sacrococcygeal malformations, spina bifida, etc; 6. Complete paraplegia; 7. Unrealistically high expectations for treatment outcomes; 8. Current use of medications that may affect intestinal motility and inability to discontinue them, such as opioids;

Design outcomes

Primary

MeasureTime frame
Complication and adverse effect;episodes of fecal incontinence per week;

Secondary

MeasureTime frame
Fecal Incontinence Quality of Life Scale;days of fecal incontinence per week;Wexner Fecal incontinence Scoring Scale;Anorectal manometry;

Countries

China

Contacts

Public ContactXinjie Huang

Beijing Childrens Hospital,Capital Medical University

huangxinjie0728@sina.com+86 10 59617689

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026