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A randomized, single blind, positive parallel controlled clinical study on the efficacy and safety of disposable titanium nickel alloy anal fistula stapler in Crohn's disease

A randomized, single blind, positive parallel controlled clinical study on the efficacy and safety of disposable titanium nickel alloy anal fistula stapler in Crohn's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063725
Enrollment
Unknown
Registered
2022-09-15
Start date
2022-09-15
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

perianal fistulizing Crohn's disease

Interventions

Group 1 :Internal Orifice Alloy Closure
Group 2:The Endorectal Advancement Flap

Sponsors

The First Affiliated Hospital of Anhui University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Refer to WHO's diagnostic criteria for Crohn's disease, and at the same time, according to the above criteria, combined with finger examination, color three-dimensional intracavitary ultrasound or pelvic magnetic resonance imaging, confirm the patients who meet Crohn's diagnosis of anal fistula; 2. Patients who have no obvious abnormality in routine examination, have not taken anticoagulant drugs, and can be operated as scheduled; 3. Age between 18 and 65 years, regardless of sex; 4. Voluntarily participate in this study and sign the consent form; 5. Good compliance, and can cooperate with the whole clinical researcher.

Exclusion criteria

Exclusion criteria: 1. Serious infection around the rectum and anal canal; 2. Patients with diabetes, severe malnutrition and other metabolic system diseases that can affect wound healing; 3. Female patients who are pregnant or breastfeeding; people who have mental illness and do not have full capacity for civil conduct; 4. Serious systemic diseases, such as malignant tumors, severe insufficiency of heart, lung, liver and kidney, blood system diseases, etc.; 5. Severe bleeding tendency, bleeding and blood coagulation disorder; 6. Patients with malignant tumors; 7. People with mental abnormalities, cognitive and communication disorders, or those who are highly stressed and uncooperative; 8. Those who have participated in clinical research within 1 month.

Design outcomes

Primary

MeasureTime frame
Healing rate of anal fistula;

Secondary

MeasureTime frame
Perianal Crohn's disease index;Inflammatory index;Postoperative pain evaluation;Anal function evaluation;

Countries

China

Contacts

Public ContactMing Li

The First Affiliated Hospital of Anhui University of Chinese Medicine

LMYS154@163.com+86 13305513200

Outcome results

None listed

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