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The optimal biologics for seton-draining perianal fistulas in Crohn's disease (TOPIC)

A prospective observational study in optimizing biologics for seton-draining perianal fistulas Crohn's disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200061986
Enrollment
Unknown
Registered
2022-07-15
Start date
2022-07-01
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Crohn's disease

Interventions

None listed

Sponsors

Renji Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

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

MeasureTime frame
fistula healing;

Secondary

MeasureTime frame
rate of radiological healing;rate of clinical response;rate of successful seton removal;rate of surgical re-interventions;

Countries

China

Contacts

Public ContactYu Minhao

Renji Hospital, Shanghai Jiaotong University School of Medicine

fishmeangood@163.com+86 13661594237

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026