Anal fistula
Conditions
Interventions
Experimental group:anal fistula plug, produced by Beijing Biosis Healing Biological Technology Co.,Ltd
Control group:anal fistula plug, market product
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) low anal fistula, and sinus (outer mouth) = 2 need to be repaired; (2) Aged 18 to 75 years old male and female; (3) Can follow the doctor's advice and return to the clinic regularly; (4) The subject agreed to participate in the clinical trial and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with = 3 sacral (external); (2) Patients with malignant diseases; (3) accompanied by cancer, intestinal tuberculosis, Crohn's disease, etc.; (4) Infection surgery or severely contaminated surgery; (5) Patients with severe cardiopulmonary disease; (6) Those with chronic kidney disease and renal insufficiency; (7) have a clear liver disease, liver dysfunction; (8) Specific allergic constitution, especially those sensitive to collagen or porcine-derived materials; (9) Those who have a history of allergies to a variety of drugs or who have recently had allergic diseases; (10) Pregnancy, lactation, and pregnancy planning; (11) Those who have participated in other clinical research within three months; (12) Patients with mental illness; (13) Subjects considered by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate;Anal incontinence rate;Healing time;pain;Doctor satisfaction;Patient satisfaction;Convenient evaluation of anal congestion; | — |
Countries
China
Contacts
Public ContactDavid
Beijing Chaoyang Hospital
Outcome results
None listed