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The efficacy of the technique of shaped skin harvesting and grafting at the surgical wound in one-stage for healing the low simple inter-sphincter anal fistula: a muti-center randomized controlled trial

The efficacy of the technique of shaped skin harvesting and grafting at the surgical wound in one-stage for healing the low simple inter-sphincter anal fistula: a muti-center randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039174
Enrollment
Unknown
Registered
2020-10-21
Start date
2020-10-25
Completion date
Unknown
Last updated
2021-01-18

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:Anal fistulotomy with shaped skin harvesting and grafting at the surgical wound in one-stage
control group:Anal fistulotomy

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Anal fistula patients meet the diagnostic criteria listed in the attached files; 2. Aged from 18-60 years; 3. Normal anal morphology and function; 4. the internal and external openings and the fistula locate in the area of 5-7 oclock in lithotomy position; 5. BMI < 30; 6. understanding,agreeing to join the study and completing the follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with traumaIBDmalignant tumourHIVtuberculosisactinomycotic infection; 2. Special patientspregnant and lactating womenwith respiratorydigestivecirculationblood system disordersliver and kidney defunction; 3. Abnormal blood sugar leveland/or other special factors (radiation damageburn) that affect the wound healing; 4. Patients with abnormal anal morphology and function; 5. Patients who underwent anal fistula operation before; 6. The internal opening and fistula are above the dental line over 1cm; 7. The number of the internal and external opening and the fistula are more than 1.

Design outcomes

Primary

MeasureTime frame
14 days cure rate;wound exudation;total cure rate;

Secondary

MeasureTime frame
scar score;operation time;hospital stay;back to work;

Countries

China

Contacts

Public ContactLi Yuying

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

lyy3855@163.com+86 13711431166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026