Crohn's disease
Conditions
Interventions
Experimental Group:The mP-T group, which will undergo the modified pull-through delayed coloanal anastomosis (mP-T) procedure.
Control Group:Control Group: This group will receive conventional medical therapy (drug regimen adjustment) combined with local perineal surgeries, including but not limited to seton drainage, fistulo
Sponsors
Central South Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in the trial: (1) Recurrent complex anorectal fistula involving the perineum; (2) Concurrent anorectal and rectovaginal fistulas; (3) Severe, long-segment rectal fibrotic stenosis; (4) Refractory rectal involvement with inadequate response to medical therapy; (5) Preoperative magnetic resonance imaging (MRI) or endoanal ultrasound confirming an intact sphincter complex; (6) Aged between 18 and 65 years; (7) Provision of written informed consent.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the trial if they meet any of the following criteria: (1) Requiring emergency surgery; (2) Impaired anal function as assessed preoperatively; (3) Current participation in another clinical trial; (4)Concurrent multiple organ dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GIQLI Questionnaire Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Colonoscopy; | — |
Countries
China
Contacts
Public ContactZhao Ding
Central South Hospital of Wuhan University
Outcome results
None listed