Factors Influencing Wound Healing After Anal Fistula Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Wound Healing Speed
研究概览
简要总结
The objective of this observational study is to analyze the factors influencing wound healing after anal fistula surgery and to assess the effectiveness of interventions in improving overall patient outcomes post-surgery. The primary questions this study aims to answer are:
- Does the use of the growth factor (New Epi) contribute to accelerating wound healing, reducing the risk of infection, and enhancing patient recovery speed after surgery?
- Do other factors, such as infection, nutritional status, diabetes, surgical methods, patient age and overall health, immune status, and lifestyle habits, affect the healing of surgical wounds?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old.
- •Have undergone anal fistula surgery with complete surgical records.
- •No significant surgical contraindications, such as:Acute infection or inflammation,Severe cardiopulmonary insufficiency,Coagulation disorders,Immunodeficiency,Local skin lesions.
- •Understand and are willing to participate in the study.Willing to sign the informed consent form.
排除标准
- •Patients under 18 years of age.
- •Pregnant or breastfeeding women.
- •Individuals with pre-existing severe heart, liver, or kidney diseases.
- •Individuals with active infections or systemic diseases.
- •Individuals who have previously undergone similar surgeries.
- •Individuals with immune dysfunction (such as HIV infection).
结局指标
主要结局
Wound Healing Speed
时间窗: Day 7 and Day 21 after surgery
1. Description: Wound healing will be assessed using AI-driven models, such as ResNet and EfficientNet, to track the healing process over time. Healing speed will be reported as the percentage of wound closure per day, based on image analysis. 2. Unit of Measure: Percentage of wound closure per day (%/day)
Postoperative Pain Assessment
时间窗: 21 days (approximately three weeks of treatment)
1. Description: Pain levels will be assessed using the Visual Analog Scale (VAS), where patients rate their pain on a scale of 0 (no pain) to 10 (worst pain). Higher scores indicate worse outcomes. 2. Unit of Measure: VAS score (0-10)
Daily Painkiller Usage
时间窗: 21 days (approximately three weeks of treatment)
1. Description: The number of pain relief medications taken by the patient each day will be recorded. This measure will assess the level of pain management required post-surgery. A higher number of painkillers used indicates more pain or less effective pain control. 2. Unit of Measure: Number of painkillers per day
Complication Rate
时间窗: 21 days (approximately three weeks of treatment)
1. Description: The incidence of complications, such as infection, bleeding, or wound dehiscence, will be tracked. The number of participants experiencing any complications will be reported. 2. Unit of Measure: Number of participants
次要结局
- Number of Participants Who Smoke(At baseline (pre-surgery))
- Number of Participants with Alcohol Consumption(At baseline (pre-surgery))
- Dietary Habits(At baseline (pre-surgery))
- Sleep Patterns(21 days (approximately three weeks of treatment))
- Nutritional Status(21 days (approximately three weeks of treatment))
- HbA1C Levels to Assess Diabetes Control(21 days (approximately three weeks of treatment))
- BUN levels(At baseline and Day 21 after surgery)
- eGFR values(At baseline and Day 21 after surgery)
- creatinine levels(At baseline and Day 21 after surgery)
- AST (SGOT) levels(At baseline and Day 21 after surgery)
- ALT (SGPT) levels(At baseline and Day 21 after surgery)
- Total Bilirubin levels(At baseline and Day 21 after surgery)
- Direct Bilirubin levels(At baseline and Day 21 after surgery)