fecal incontinence after pull-through surgery for Hirschsprung's disease, defecation disorders
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Complication and adverse effect;episodes of fecal incontinence per week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal Incontinence Quality of Life Scale;days of fecal incontinence per week;Wexner Fecal incontinence Scoring Scale;Anorectal manometry; | — |
Countries
China
Contacts
Beijing Childrens Hospital,Capital Medical University