Crohn's disease anal fistula
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18–60 years old; 2. Patients with moderate-to-severe active Crohn's disease (CD), defined as a CDAI score > 220 points; 3. Patients clinically diagnosed with Crohn's disease anal fistula based on medical history, physical examination, and ancillary tests, requiring surgical intervention; 4. No prior treatment with biologic agents; 5. ASA I-II status with adequate organ function; 6. Voluntary participation in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrollable severe infections in the rectum and perianal area; 2. Patients with contraindications to biologic agents, including but not limited to: severe cardiac disease, acute infections, demyelinating neurological disorders, tuberculosis, hepatitis B, cytomegalovirus infection, and other infectious diseases; 3. Patients who have received systemic steroid therapy within the past month; 4. Patients with concomitant autoimmune diseases or malignancies; 5. Patients unable to tolerate surgery due to severe emphysema, pulmonary bullae, interstitial pneumonia, ischemic heart disease, or coagulation disorders; 6. Vulnerable populations, including critically ill patients, individuals with psychiatric disorders, those with cognitive impairment, pregnant or lactating women, minors, and illiterate individuals; 7. Patients or family members unable to comprehend the conditions and objectives of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anal fistula healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging-based fistula healing rate;PDAI Score;CDAI Score;Wexner Score; | — |
Countries
China
Contacts
Renji Hospital, Shanghai Jiao Tong University School of Medicine