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Clinical Efficacy Observation of Modified TROPIS Surgery for High Intersphincteric Anal Fistula Based on the Theory of "Opening the Orifice to Expel Pathogens and Let Toxins Discharge Externally"

Clinical Efficacy Observation of Modified TROPIS Surgery for High Intersphincteric Anal Fistula Based on the Theory of "Opening the Orifice to Expel Pathogens and Let Toxins Discharge Externally"

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002358
Enrollment
Unknown
Registered
2025-11-28
Start date
2025-07-31
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

high anal fistula

Interventions

Experimental group:Modified TROPIS procedure
Control Group:Traditional Incision and Thread-Drawing Surgery

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18-75 years old, with no restriction on gender; (2) Patients with high anal fistula (intersphincteric type) confirmed by preoperative pelvic MRI examination. (3) Voluntarily participate in this clinical trial, understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with comorbidities such as diabetes, severe cardiovascular system diseases, hematological system diseases, and abnormal liver or kidney function; (2) Patients with high anal fistula caused by the following diseases: Crohn's anal fistula, rectovaginal fistula, colorectal inflammation, tuberculosis, HIV, tumors, or trauma; (3) Patients with confirmed anal sphincter insufficiency by preoperative anorectal manometry or anorectal ultrasound, or those with recurrent fistula lesions after previous radical surgery for anal fistula; (4) Special populations: pregnant women, lactating women, and patients with severe mental disorders; (5) Patients or their family members who refuse follow-up midway or are lost to follow-up due to incomplete data.

Design outcomes

Primary

MeasureTime frame
Evaluation of Clinical Efficacy and Recurrence;

Secondary

MeasureTime frame
Postoperative Pain and Postoperative Complications;Anal Function: Wexner Score;Anorectal Manometry;

Countries

china

Contacts

Public Contactzhaoweibing

Xiyuan Hospital of China Academy of Chinese Medical Sciences

zwb903@sina.com13647200896

Outcome results

None listed

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