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Standardized treatment for Parks type II - III of anal fistula

Multicenter study for standardized treatment for Parks type II - III of anal fistula

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022810
Enrollment
Unknown
Registered
2019-04-26
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-04-30

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

Conditions

anal fistula

Interventions

1-1:video-assisted anal fistula treatment
1-2:ligation of the intersphincteric fistula tract
1-3:control group
2-1:video-assisted anal fistula treatment plus plug
2-2:control

Sponsors

Beijing Erlonglu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for anal fistula in accordance with the 2006 edition of Clinical Guidelines for Diagnosis and Treatment of Anal Fistula; 2. Anal fistula with adenogenic infection; 3. Meet the diagnostic criteria of Parks II and III anal fistula; 4. Anal function is good, with no anal relaxation, stenosis, infection and deformity; 5. Subjects agree to participate in the clinical trial and sign informed consent; 6. Between the ages of 18-65 years old; 7. Systemic diseases such as cardiovascular and cerebrovascular diseases and metabolic diseases are in a stable phase; 8. Physical assessment is good, cardiopulmonary function can withstand surgery; 9. Subjects can follow the doctor's advice and visit regularly.

Exclusion criteria

Exclusion criteria: 1. Parks?, ? type fistula 2. Those who with cancer, intestinal tuberculosis, ulcerative colitis, Crohn's disease, etc. 3. Those with poorly controlled diabetes, blood sugar is still greater than 8.0 after drug control, 4. Patients with severe cardiopulmonary disease 5. Patients with chronic kidney disease, renal dysfunction, with serum Cr greater than the upper limit of normal 6. Patients with clear liver disease, liver dysfunction, ALT or AST exceeded the upper limit of normal value by 2.5 times 7. Patients with specific allergic constitution, especially those sensitive to collagen or porcine materials 8. Patients with a history of allergies to multiple classes of drugs or those with recent allergies 9. Patients who is in the stage of pregnancy, lactation, or planing to be pregnant 10. Patients who has been participated in other clinical researchers within six months 11. Patients with mental illness 12. Subjects considered by the investigator not suitable for this clinical trial

Design outcomes

Primary

MeasureTime frame
Wexner Score;the Traditional Chinese version of the faecal incontinence quality of life scale, FIQL;The cure rate;Recurrence of anal fistula;

Secondary

MeasureTime frame
Wound healing time;Length of hospital stay;pain;Hospitalization expenses;Intraoperative blood loss;

Countries

China

Contacts

Public ContactZhang Yuru

Beijing Erlonglu Hospital

zhyr_11@163.com+86 13611156369

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026