Complex anal fistulas
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years; 2. Anal fistula classified as inter-sphincteric according to the Parks classification, with an external opening spanning multiple perianal quadrants; 3. No prior history of anal surgery (i.e., undergoing their first anal surgical procedure); 4. Voluntary participation in this clinical trial, provision of written informed consent, and willingness and ability to comply with clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Presence of any condition that precludes receipt of the study treatment, including religious or ethnic contraindications, diabetes, malignancy, intestinal tuberculosis, Crohn's disease, or acquired immunodeficiency syndrome (AIDS); 2. Presence of acute infection or poorly controlled local infectious foci; 3. Presence of severe comorbid conditions involving the heart, lungs, brain, liver, or kidneys; 4. Pregnancy, planned pregnancy, or current lactation; 5. Cognitive impairment that precludes the ability to complete questionnaire-based assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anorectal manometry parameters ;Fecal Incontinence Quality of Life Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| The Multidimensional Satisfaction Questionnaire;Decision Regret Scale;Clinical Outcomes: Record healing rates, healing times;Wound Response and Safety Evaluation ;Evaluation of postoperative dressing change burden; | — |
Countries
China
Contacts
Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital