The Clinical Study of a New Modified Bareness of External Anal Sphincter (BEAS) for High Complex Anal Fistula

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200063484

Enrollment

Unknown

Registered

2022-09-08

Start date

2022-11-01

Completion date

Unknown

Last updated

2023-04-17

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

Conditions

High horseshoe anal fistula

Interventions

Group A:modified bareness of external anal sphincter

Group B:modified ligation of intersphincteric fistula

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Conform to the diagnosis of high complex anal fistula, including one of the following types: high linear transsphincteric fistula (> 1/3 external sphincter involvement) or anterior wall anal fistula of female anal canal; high transsphincteric anal fistula (> 1/3 external sphincter involvement) combined with abscesses, multiple fistulas or horseshoe-shaped anal fistulas; high transsphincteric anal fistulas (> 1/3 external sphincter involvement) and involving the supralevator space, suprasphincteric anal fistulas, and extrasphincteric anal fistulas; 2. Aged 18-65 years; 3. Those who voluntarily accept surgical treatment; 4. Complete informed consent and relevant notification, and be able to cooperate with outpatient follow-up and observers.

Exclusion criteria

Exclusion criteria: 1. Have a history of anal surgery and seriously affect anal function; 2. Anal fistula caused by the rupture of rectal and anal malignant tumor; 3. Anal fistula caused by specific infections such as tuberculosis, Crohn's disease, and ulcerative colitis; 4. Anal fistula caused by trauma; 5. Rectovaginal fistula; 6. Those who are accompanied by serious cardiovascular and cerebrovascular, digestive, respiratory, and mental system diseases and cannot undergo surgery; 7. Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Healing rate;Recurrence rate;Postoperative complications;	—

Secondary

Measure	Time frame
Anal incontinence score;Postoperative pain score;Patient Satisfaction Score;	—

Countries

China

Contacts

Public ContactJin Xu

Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai

572715396@qq.com+86 18715013530

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026