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Clinical study of treating Anal Fistulas with a Novel Extracellular Matrix Derived from Porcine Urinary Bladder

Clinical study of treating Anal Fistulas with a Novel Extracellular Matrix Derived from Porcine Urinary Bladder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071594
Enrollment
Unknown
Registered
2023-05-18
Start date
2023-05-19
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

fistula

Interventions

Experimental group:After the patient was successfully anesthetized, a conventional disinfection cloth was spread, and the fistula external mouth was injected with methylene blue for develop the intern
A 3-0 absorbable thread at the outer mouth is sutured through the biomaterial to secure a stitch to prevent the biomaterial from moving and falling off. The surgical area is bandaged with gauze a

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1. Subject voluntarily joins the study and signs informed consent form 2. (1) Meet the diagnostic criteria for fistula formulated by the Proctology Group of the Surgical Branch of the Chinese Medical Association; (2) preoperative incontinence score of 0; (3) Age 20~70 years olda

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. fissure, stenosis, sinusitis, anorectal tumor, moderate to severe colitis and other diseases; 2. Those with cardiovascular and cerebrovascular diseases, blood diseases and contraindications to surgery; 3. Those with mental disorders or history of mental illness; 4. Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
Surgical cure rate;

Secondary

MeasureTime frame
anus function;rehabilitation time;Intraoperative bleeding;Postoperative bleeding;infection rate;pain;urinary retention;Urgency of defecation;Treatment satisfaction;Treatment costs;

Countries

China

Contacts

Public ContactMa Xiang

Shenzhen Second People's Hospital

drmaxiang2@163.com+86 135 5687 8865

Outcome results

None listed

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