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Treatment of High Complex Anal Fistulas by Modified External Sphincter-preserving Surgery or Ligation of Intersphincteric Fistula Tract (LIFT): A Prospective Randomized Controlled Study

Modified External Sphincter-preserving Surgery for the Treatment of High Complex Anal Fistulas: A Prospective Randomized Controlled Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076874
Enrollment
Unknown
Registered
2023-10-23
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Anal fistula

Interventions

Experimental group:Modified External Sphincter-preserving Surgery
Control group:Ligation of Intersphincteric Fistula Tract

Sponsors

The Sixth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years old; 2. High trans-sphincter anal fistula (the track involved >1/3 of the external sphincter), confirmed by contrast enhanced MRI of anus; 3. Patients and their families understand and are willing to participate in the study, sign informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, etc; 2. Previous history of malignant colorectal tumors within 5 years; 3. Patients with severe impairment of liver function, kidney function and cardiopulmonary function, coagulation dysfunction, or other underlying diseases that might not tolerate surgery; 4. History of serious mental illness 5. Pregnant or lactating women 6. Patients with history of diabetes, tuberculosis and other diseases;

Design outcomes

Primary

MeasureTime frame
Initial healing rate within 6 months after surgery;

Secondary

MeasureTime frame
Fecal incontinence score 1 year after surgery;Postoperative quality-of-life score;Postoperative wound healing time;Postoperative complication rate;Overall healing rate within 6 months after surgery;

Countries

China

Contacts

Public ContactLiu Zhimin

The Sixth Affiliated Hospital of Sun Yat-sen University

liuzhm3@sysu.edu.cn+86 138 0244 1221

Outcome results

None listed

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