Anal fistula
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Recurrence rate;Time of wound epithelialization; | — |
Secondary
| Measure | Time 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
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine