Anal Fistula
Conditions
Keywords
Anal fistula
Brief summary
This study adopted a randomized, double-blind, placebo-controlled clinical trial design to evaluate the efficacy and safety of Zuoqing San fumigation and washing on the wound healing after anal fistula surgery.
Detailed description
A total of 60 patients who underwent anal fistula surgery at the Second Affiliated Hospital of Anhui University of Chinese Medicine from September 2024 to March 2025 were included. They were randomly divided into the experimental group (treated with Left Qing San fumigation and washing) and the control group (treated with placebo fumigation and washing) at a ratio of 1:1.
Interventions
DRUGSolution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula
Left Qing San Decoction (25g of Cai Yin + 30g of Eucommia + 25g of Sophora flavescens + 25g of Anemarrhena asphodeloides + 15g of Lithospermum erythrorhizon, prepared in the Pharmacy Department of Anhui University of Traditional Chinese Medicine), add 1000mL of water, boil, then steam and wash the wound surface. The temperature is 40 ± 2℃. Do it once a day, for 15 minutes each time, for 7 consecutive days.
OTHEREqual-volume placebo inhalation rinse
Equal-volume placebo inhalation rinse
Sponsors
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Inclusion criteria\*\* 1\. \*\*Western medical diagnostic criteria\*\* (refer to Surgery for Anorectal Diseases 2018 edition): * History of recurrent swelling and pus discharge around the anus; * Confirmed presence of fistula through preoperative MRI or ultrasound; * Undergone incisional surgery for anal fistula, with postoperative wound diameter ranging from 2 to 4 cm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recurrent swelling and pain, along with pus discharge around the anus; * Preoperative MRI or ultrasound confirmed the presence of the fistula; * Underwent incision of the anal fistula, with the postoperative wound diameter ranging from 2 to 4 cm.
Exclusion criteria
1. Inflammatory bowel disease (such as Crohn's disease) related anal fistula; 2. Complicated with severe dysfunction of heart, liver and kidney (ALT/AST \> 2 times upper limit, Cr \> 1.5 mg/dL); 3. Pregnant or lactating women; 4. Those who are known to be allergic to the components of Zuoqing San;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing time | From postoperative day 1 until wound healing is achieved (assessed daily during hospitalization and weekly after discharge, up to 8 weeks) | The number of days from the day after the operation until the wound surface is completely covered by epithelium (as observed by the naked eye, there is no exudation, and upon palpation, the scar is smooth). |
Countries
China
Outcome results
None listed