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Clinical Study on Progressive Threading Therapy Based on Sphincter Protection for Transphenteric Anal Fistula of Damp-heat Downward Type

Clinical Study on Progressive Threading Therapy Based on Sphincter Protection for Transphenteric Anal Fistula of Damp-heat Downward Type

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000761
Enrollment
Unknown
Registered
2025-04-15
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

transsphincteric fistula

Interventions

observation group:Progressive thread-drawing based on sphincter protection
control group:incision and thread-drawing

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) It meets the diagnostic criteria of anal fistula through sphincter and receives surgical treatment; it meets the diagnostic criteria of damp-heat downward type in the Guide for Diagnosis and Treatment of Common Diseases in Anorectal Department of Traditional Chinese Medicine; (2) Patients aged between 18 and 65 years old male and female; (3) digital rectal examination and MRI suggested transsphincteric anal fistula; (4) Anus appearance and function were normal before operation; (5) No previous anal fistula surgery.

Exclusion criteria

Exclusion criteria: (1) Enrolled patients aged>65 years or <18 years; (2) There are heart and cerebrovascular diseases or liver kidney and blood system diseases; (3) anal fistula caused by rectal presacral tumor tuberculosis Crohn's disease and other factors; (4) Pregnancy or lactation; (5) accompanied by perianal eczema diarrhea and other diseases; (6) Mental disorders cannot communicate normally.

Design outcomes

Primary

MeasureTime frame
healing rate;

Secondary

MeasureTime frame
healing days;Anorectal Manometry Parameters (AMP);Cleveland Clinic Incontinence Score;Quality of Life Assessment for Anal Function Questionnaire Score;Visual Analogue Scale;

Countries

China

Contacts

Public ContactWang Qingming

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

davidwqm@163.com+8613816903904

Outcome results

None listed

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