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Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula

Clinical Study of Decompression and Drainage Seton for the Treatment of High Horseshoe Anal Fistula

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05044182
Acronym
DADS
Enrollment
92
Registered
2021-09-14
Start date
2021-10-08
Completion date
2024-01-31
Last updated
2023-02-16

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

Conditions

Anal Fistula

Brief summary

Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting seton.

Interventions

PROCEDUREDecompression 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
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients suffering from high horseshoe anal fistula

Exclusion criteria

* Specific cause of fistula e.g. Crohn's disease. * Previous anorectal surgery. * Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment. * Patients with serious primary diseases such as tumor, malnutrition, endocrine and hematopoietic system.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate12 months after the procedurerecurrence was defined as the clinical reappearance of the fistula after complete healing.

Countries

China

Contacts

Primary ContactHui Li, bachelor
358219241@qq.com0861084206250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026