Skip to content

Efficacy and safety evaluation of integrated traditional Chinese and western medicine perioperative program of loose combined cutting seton for high horseshoe anal fistula

Efficacy and safety evaluation of integrated traditional Chinese and western medicine perioperative program of loose combined cutting seton for high horseshoe anal fistula

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093477
Enrollment
Unknown
Registered
2024-12-05
Start date
2023-02-09
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

High horseshoe shaped anal fistula

Interventions

Traditional debridement and dressing change:Traditional debridement and dressing change plus traditional Chinese medicine sitz bath
Simple dressing change:Simple dressing change plus Chinese medicine sitz bath
Postoperative antibiotic application:Use clinical antibiotics and traditional Chinese medicine sitz bath
No antibiotics after surgery:Traditional Chinese medicine sitz bath, no antibiotics for one week after surgery

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old and <=65 years old; 2.Patients voluntarily participated in clinical trials, all signed informed consent, and were able to cooperate with clinical follow-up; 3.Patients clinically diagnosed with high horseshoe anal fistula (in line with Parks diagnostic criteria) affect daily life and work, and internal conservative treatment is ineffective; 4. Imaging diagnosis supports the diagnosis of high horseshoe anal fistula, and surgical treatment is proposed. If you meet 1+3 or 4 or 3,4, you can be included

Exclusion criteria

Exclusion criteria: 1. High horseshoe anal fistula caused by trauma; 2. Patients with acute infection or focal infection control is poor, requiring a long course of antibiotics or upgraded antibiotics; 3. doctors determine that other medical history affects anal function; 4. With other diseases: uncontrollable diabetes, uncontrolled malignant tumors, intestinal tuberculosis, Crohn's disease, AIDS; 5. Patients with severe heart, lung, liver, kidney and nervous system diseases; 6.Women who are pregnant or planning to become pregnant and women who are breastfeeding; 7. A variety of antibiotic allergy.

Design outcomes

Primary

MeasureTime frame
Long term follow-up recurrence rate;Postoperative wound healing rate;Postoperative fistula healing rate;

Secondary

MeasureTime frame
Postoperative fever ;The incidence of adverse events;Visual Analogue Scale, VAS;Time for the wound to heal completely;Serum CRP changes;Wound secretion;Wound edema;Granulation morphology;Wound depth;Duration of each dressing change;Serum leukocyte change;Serum neutrophil changes;

Countries

China

Contacts

Public ContactZheng Lihua

China-Japan Friendship Hospital

btv126@126.com+86 133 6656 6578

Outcome results

None listed

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