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Clinical study on the treatment of intersphincteric fistula with anal fistula clip

Clinical study on the treatment of intersphincteric fistula with anal fistula clip

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123117
Enrollment
Unknown
Registered
2026-04-22
Start date
2026-04-27
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Intersphincteric anal fistula

Interventions

Experimental Group:Anal Fistula Clamp (AFC) surgery
Control Group:Incisional Thread-Drawing Therapy for Anal Fistula

Sponsors

Beijing Anorectal Hospital (Beijing Erlong Road Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for intersphincteric anal fistula in the 2025 edition of the "Guidelines for Diagnosis and Treatment of Anal Fistula with Integrated Traditional Chinese and Western Medicine", and confirmed by ultrasound examination of the anal cavity. 2. All patients are aged between 18 and 65 years old, with no history of anal surgery. 3. No severe dysfunction of important organs such as the heart, lungs, liver, and kidneys. 4. Familiar with and understand the specific content of this study and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with intersphincteric anal fistula caused by other diseases, such as inflammatory bowel disease, tumors, etc.; patients with concurrent acute abscess, rectal polyps, and other diseases. 2. Patients with abnormal blood coagulation. 3. Pregnant or lactating women. 4. Patients with limited self-mobility. 5. Patients who do not follow medical advice, have poor compliance, and cannot adhere to completing the entire study due to illness or pain.

Design outcomes

Primary

MeasureTime frame
Incidence of Anal Incontinence;

Secondary

MeasureTime frame
Cure Rate;Intraoperative Blood Loss;Operation Time;Length of Hospital Stay;VAS Score on the 1st, 3rd, and 7th Postoperative Days;Wound Healing Time;Wexner Score at 6 Months Postoperatively;Incidence of Postoperative Complications;

Countries

China

Contacts

Public ContactHan Xu

Beijing Anorectal Hospital (Beijing Erlong Road Hospital)

hanxu198413@126.com+86 10 5776 3195

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026