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Clinical study on the treatment of high complex anal fistula with the combination of anal fistula clip closure, internal sphincter reconstruction, and fistula biological plug filling

Clinical study on the treatment of high complex anal fistula with the combination of anal fistula clip closure, internal sphincter reconstruction, and fistula biological plug filling

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098371
Enrollment
Unknown
Registered
2025-03-06
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

High complex anal fistula

Interventions

Experimental group:Process: After successful anesthesia, the patient is routinely disinfected. Methylene blue developer is injected into the external opening of the anal fistula to visualize the inter
Cut the incision between the internal and external anal sphincters to 1-2cm above the level of the fistula tract (confirm the distance based on the specific area of the fistula tract and anal sphincte
Fill the decellularized bladder matrix anal fistula plug from the external opening

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Volunteers willingly participate in the study and sign an informed consent form. 2. (1)Meet the diagnostic criteria for high-grade complex anal fistula according to the 2022 American Society of Colorectal and Fecal Incontinence Surgeons (ASCFIS) guidelines: Diagnosed as high-grade complex anal fistula(2) The preoperative anal incontinence score is 0 points; (3) Age between 18 and 70 years old

Exclusion criteria

Exclusion criteria: 1. Combined anal diseases such as anal antrum inflammation, anorectal tumors, and moderate to severe colitis; 2. Those who have combined cardiovascular and cerebrovascular diseases, hematological diseases, and surgical contraindications; 3. Individuals with mental disorders or a history of mental illness; 4. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Healing status of fistula tract;Anus function;Rehabilitation time;

Secondary

MeasureTime frame
Intraoperative bleeding;Postoperative bleeding;Infection rate;Pain;Urinary retention;Urgency of defecation;Treatment satisfaction;Treatment costs;Anal prolapse and swelling;Exclusion reaction;Allergic reactions;

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