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Clinical study on the treatment of transsphincter type anal fistula by fistula ligation and intersphincter incision

Clinical study on the treatment of transsphincter type anal fistula by fistula ligation and intersphincter incision

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122897
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

anal fistula

Interventions

Observation Group:fistula ligation and intersphincter incision
Control Group:Ligation of the Intersphincteric Fistula Tract

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients who have not undergone previous surgical treatment, or those who initially only received incision and drainage during the perianal abscess stage. 2. Aged 18 to 60 years. 3. Diagnosed with transsphincteric anal fistula by endoanal ultrasound and/or pelvic MRI. 4. Normal anal sphincter function assessed both subjectively and objectively using the Wexner incontinence score and anorectal manometry. 5. Able to read and understand Chinese, and willing to provide consent to participate in this study. 6. Agree not to use any other treatments for anal fistula during the trial period.

Exclusion criteria

Exclusion criteria: 1. Patients with inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), radiation enteritis, tuberculous anal fistula, etc. 2. Pregnant or lactating women, and patients with cardiac, pulmonary, hepatic, or renal insufficiency who cannot tolerate surgery. 3. Patients with intellectual or mental disorders. 4. Patients currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
healing status;

Secondary

MeasureTime frame
anal function;complications;operation time;length of hospital stay;return-to-work time;hospitalization cost;wound healing time;postoperative pain;patient satisfaction;

Countries

China

Contacts

Public ContactHou Yi

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

wangtianzuxiaowu@163.com+86 132 6076 5789

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026