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A multi-center clinical study on the treatment of high complex anal fistulas based on the

A multi-center clinical study on the treatment of high complex anal fistulas based on the

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037426
Enrollment
Unknown
Registered
2020-08-28
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-10-13

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 (High complex anal fistula contralateral incision and loose-tight seton):High complex anal fistula contralateral incision and loose-tight seton
Control group (Traditional incision and seton):Traditional incision and seton

Sponsors

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) met the above diagnostic criteria of high complex anal fistula and received surgical treatment; (2) patients aged between 18 and 65 years old, male or female; (3) digital rectal examination, intraluminal rectal ultrasound and MRI indicated the formation of anal fistula; (4) normal appearance and function of anus before operation; (5) those who had signed informed consent form.

Exclusion criteria

Exclusion criteria: (1) pregnant or lactating women; (2) patients with infectious diseases of digestive tract; (3) patients with severe diseases or mental illness of circulatory system, hematopoietic system, digestive system and important organs; (4) patients with severe allergy and coagulation dysfunction. (5) patients with anal fistula caused by specific infection (such as tuberculosis, Crohn's disease, ulcerative colitis, etc.) or rupture of rectoanal malignant tumor; (6) patients who have participated in other clinical trials in the past four weeks; (7) patients who are unable to cooperate with the completion of the research plan, including language difficulties, infectious diseases and other medical history.

Design outcomes

Primary

MeasureTime frame
Healing time;

Secondary

MeasureTime frame
Quality of life of patients with anal fistula;anal incontinence;Persistent state of anal fistula;Recurrence rate of anal fistula;Incidence of postoperative complications;pain;

Countries

China

Contacts

Public ContactWei Yang

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

yangweiyishi@163.com+86 13917198396

Outcome results

None listed

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