Crohn's disease
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-60 years old; 2. ASA I-II level; 3. Moderately to severely active intestinal Crohn's disease (CD) patients, that is, CDAI score > 220 points, combined with anal fistula, with or without local infection; 4. Have not received biological agent treatment before; 5. Sufficient organ function.
Exclusion criteria
Exclusion criteria: 1. Uncontrollable perianal infection; 2. Concomitant contraindications to the use of biological agents, including but not limited to: severe heart disease, acute infection, demyelinating lesions of the nervous system, tuberculosis, hepatitis B, cytomegalovirus infection and other infectious diseases; 3. Patients with severe emphysema, bullae, interstitial pneumonia or ischemic heart disease who cannot tolerate surgery; 4. Pregnant or lactating women; 5. Severe mental illness; 6. Received systemic steroid therapy within 1 month; 7. Combined with malignant tumors; 8. Patients or family members cannot understand the conditions and objectives of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fistula healing; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of radiological healing;rate of clinical response;rate of successful seton removal;rate of surgical re-interventions; | — |
Countries
China
Contacts
Renji Hospital, Shanghai Jiaotong University School of Medicine