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Application study of modified transanal opening of intersphincteric space (TROPIS) and thread-hanging therapy in treating high anal fistula

Application study of modified transanal opening of intersphincteric space (TROPIS) and thread-hanging therapy in treating high anal fistula

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052055
Enrollment
Unknown
Registered
2021-10-15
Start date
2021-10-18
Completion date
Unknown
Last updated
2022-06-27

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 transanal opening of intersphincteric space (TROPIS) and thread-hanging therapy

Sponsors

Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of high anal fistula; 2. Patients who have not received surgical treatment, or who have undergone only incision and drainage at the initial stage of perianal abscess; 3. Aged 18-65 years, male or female; 4. Patients with normal anal sphincter function; 5. Patients with Chinese reading ability and informed consent to the study; 6. During the trial period, patients need to agree not to use other treatments for anal fistulas.

Exclusion criteria

Exclusion criteria: 1. Patients with Crohn's disease, inflammatory bowel disease such as ulcerative colitis, radiation enteritis or tuberculous anal fistula, etc.; 2. Pregnant and lactating women, patients with diabetes, connective tissue diseases or related metabolic diseases, patients with heart, lung, liver, kidney disease, hemolytic disease, etc.; 3. Patients with mental retardation or(and) mental disorders; 4. Patients participating in other clinical trial.

Design outcomes

Primary

MeasureTime frame
Operation time;The amount of bleeding during the operation;Hospitalization days;VAS(visual analogue score);Wound area;Wound healing time;Recurrence rate;Postoperative complications;Anal sphincter function;

Countries

China

Contacts

Public ContactZheng Xueping

Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine

zhengxp025@163.com+86 13851436098

Outcome results

None listed

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