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A Clinical Study on the Combined Application of Multiple Incisions Tract-Draining Tubes and Suspension Suture Technique for the Treatment of High-Level Horsehoe-Shaped Anal Fistulas

A Clinical Study on the Combined Application of Multiple Incisions Tract-Draining Tubes and Suspension Suture Technique for the Treatment of High-Level Horsehoe-Shaped Anal Fistulas

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000688
Enrollment
Unknown
Registered
2025-04-10
Start date
2024-12-20
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

Anal fistula

Interventions

Experimental group:Multiple Incisions Tract-Draining Tubes and Suspension Suture Technique

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)Diagnosis of high horseshoe-type anal fistula (complete horseshoe-type/partial horseshoe-type) according to the Criteria for Diagnosis and Therapeutic Efficacy of TCM Diseases and Syndromes (National Administration of Traditional Chinese Medicine) and the 2006 Clinical Guidelines for Anal Fistula Management (jointly issued by ??the?? Chinese Society of Coloproctology Chinese Association of Traditional Chinese Medicine???? Colorectal and Anal Surgery Group???? Chinese Medical Association???? and Colorectal and Anorectal Diseases Committee???? Chinese Association of Integrative Medicine);2)Confirmation via transrectal ultrasound (TRUS) or contrast-enhanced perianal MRI (EMRI);3)Hospitalized patients aged 18–65 years with no sex-based exclusion criteria;4)Anatomically intact anal canal;5)Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1)Pregnant or lactating women;2)Malignancies or specific infections (e.g. tuberculosis Crohn's disease ulcerative colitis) confirmed by colonoscopy;3)Concurrent severe anorectal disorders including mixed hemorrhoids anal fissures or perianal eczema;4)Severe systemic comorbidities (e.g. circulatory hematopoietic or digestive system dysfunction major organ failure) or psychiatric disorders;5)Severe allergies or coagulation dysfunction;6)Participation in other clinical trials within the preceding 4 weeks.

Design outcomes

Primary

MeasureTime frame
Recurrence rate;Time of wound epithelialization;

Secondary

MeasureTime frame
Treatment response grading;Anorectal manometry;Symptom score evaluation;Quality of life assessment;Symptom score;Anal incontinence score;Fecal Incontinence Quality of Life Assessment ;

Countries

China

Contacts

Public ContactYe Han

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

18017752552@163.com+86 180 1775 2552

Outcome results

None listed

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