High Complex Anal Fistula
Conditions
Brief summary
This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula.
Interventions
PROCEDUREDecomprssion and drainage seton
Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.
PROCEDURECutting seton
Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* high trans-sphincteric cryptoglandular anal fistulas (involving \>30% of the EAS muscles evaluated through magnetic resonance imaging (MRI) scan, endoanal ultrasonography) * suprasphincteric fistulas were enrolled
Exclusion criteria
* Low anal fistula; -Non-glandular anal fistulas, such as tuberculous anal fistula and Crohn's anal fistula; - * Patients with symptoms of fecal incontinence; * A previous history of anal fistula surgical treatment; * Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of healing | 6 months post-operation. | complete healing was defined as complete epithelialization of the wound, with no evidence of external fistula opening or perianal discharge under physical examination. |
| Recurrence rate | within 12 months after the procedure | recurrence was defined as the clinical reappearance of the fistula after complete healing, removal or fall-off of seton |
| The healing time of the anal wound (days) | 6 months post-operation. | the time needed to achieve complete healing of anal fistula. |
Countries
China
Outcome results
None listed