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A randomized, single-blind, positive parallel controlled clinical trial for disposable titanium-nickel memory alloy anal fistula internal stapler for clinical efficacy and safety of anal fistula closure

A randomized, single-blind, positive parallel controlled clinical trial for disposable titanium-nickel memory alloy anal fistula internal stapler for clinical efficacy and safety of anal fistula closure

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029287
Enrollment
Unknown
Registered
2020-01-20
Start date
2018-11-01
Completion date
Unknown
Last updated
2020-02-03

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:Disposable titanium-nickel memory alloy anal fistula
Control group:Conventional Fistulotomy

Sponsors

Nanjing Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed as anal fistula patients, the anal fistula needs to be closed for treatment; 2. Aged 18 to 65 years; 3. Those who voluntarily participate in the trial and sign the informed consent form; 4. Compliance is good, can cooperate with the completion of the entire clinical trial.

Exclusion criteria

Exclusion criteria: 1. The rectum has obvious inflammation; 2. Anal fistula acute phase abscess formation; 3. Those who are using anticoagulant and blood circulation agent within one week before enrollment; 4. Severe bleeding tendency, bleeding, coagulation disorders; 5. Patients with allergies; 6. In general, patients with severe heart or lung disease, or other serious illness patients; 7. Patients with malignant tumors; 8. People with mental disorders, cognitive and communication disabilities, or those who are highly nervous and uncooperative; 9. Pregnant or lactating women; 10. Those who have participated in clinical trials within 1 month; 11. Other investigators believe that it is not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Anal fistula internal mouth healing rate;

Secondary

MeasureTime frame
Anal fistula cure rate;Anal function evaluation;Postoperative pain assessment;Product performance;

Countries

China

Contacts

Public ContactYang Zhang

Nanjing Chinese Medicine Hospital

843340839@qq.com+86 18724133209

Outcome results

None listed

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