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Clinical study on the treatment of Crohn's disease anal fistula with biologics combined with anal fistula closure clip

Clinical study on the treatment of Crohn's disease anal fistula with biologics combined with anal fistula closure clip

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087786
Enrollment
Unknown
Registered
2024-08-05
Start date
2024-08-15
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

perianal fistulizing Crohn's disease

Interventions

Experimental group:Biologics combined with anal fistula closure clip

Sponsors

Nanjing University of Traditional Chinese Medicine Affiliated Hospital (Jiangsu Provincial Hospital of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as a pfCD patient who meets the above diagnostic criteria and has no severe infection in the anal fistula area. 2. Aged 18 to 65 years old, gender not limited. 3. Those who agree to participate in clinical research are willing to cooperate with clinical physicians to observe and sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Individuals with severe infections in the rectum and anal canal; 3. Individuals with severe heart, liver, kidney diseases and coagulation dysfunction (including those undergoing anticoagulant therapy), a history of pelvic radiation therapy, severe immune dysfunction, and a recent (within 3 months) history of sclerosing agent injection therapy at the anal fistula site; 4. Individuals with mental abnormalities, cognitive and communication disorders, or high levels of mental stress that do not conform to the author's requirements; 5. Individuals with incomplete case information; 6. Medical staff determine that other users are not suitable;

Design outcomes

Primary

MeasureTime frame
Clinical healing rate of fistula;Healing rate of fistula imaging;Clinical remission rate of CD;Endoscopic remission rate;

Secondary

MeasureTime frame
Fistula response rate;CD clinical response rate;Endoscopic response rate;The state of anal sphincter function;

Countries

China

Contacts

Public ContactHao Wang

Nanjing University of Traditional Chinese Medicine Affiliated Hospital (Jiangsu Provincial Hospital of Traditional Chinese Medicine)

cnzhwh@126.com+86 138 5165 6633

Outcome results

None listed

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