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The application of novel photocurable medical bio-adhesive in anal fistula minimally invasive surgery

To evaluate the efficacy and safety of the new photocurable medical bioadhesive applied in minimally invasive anal fistula surgery and wound dressing change after anorectal diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053776
Enrollment
Unknown
Registered
2021-11-29
Start date
2021-11-10
Completion date
Unknown
Last updated
2024-01-28

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:Light-curing medical bio-adhesive group
Control Group:Traditional dressing

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with glandular anal fistula whose imaging examination (MRI) conforms to Parks classification; 2. The fistula is in a stable stage, and has not received any specialized instruments or surgical treatment within the past 3 months; 3. No contraindications to surgery; 4. Aged 18 to 65 years; 5. The subjects have no major organ dysfunction, and the blood routine, liver, kidney, and heart functions are normal; 6. Understand and agree to participate in this study, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with other anorectal diseases or surgery (including colorectal cancer, Crohn's disease, ulcerative colitis, intestinal tuberculosis, etc.). 2. Those with hematopoietic and coagulation disorders; 3. Severe heart, liver, kidney, pulmonary insufficiency and other diseases; 4. Pregnant or lactating patients; menstrual patients; 5. People with a history of mental illness that is not easy to control; 6. Fistula accompanied by pain and pus discharge.

Design outcomes

Primary

MeasureTime frame
Wound healing;Anal sphincter function (including FISI score, anorectal pressure);

Countries

China

Contacts

Public ContactHan Changpeng

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

13918314533@163.com+86 139 1831 4533

Outcome results

None listed

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