Clinical trial NCT06592157: Factors Influencing Wound Healing After Anal Fistula Surgery
Official title: Factors Influencing Wound Healing After Anal Fistula Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anal Fistula Surgery
Keywords: Ep ithelial Growth Factor New Epi
Anal Fistula Surgery
Wound Care
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing fistula surgery at Taichung Veterans General Hospital.

Brief summary: 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:

1. 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?
2. 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?


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Wound Healing Speed
timeFrame: Day 7 and Day 21 after surgery
measure: Postoperative Pain Assessment
timeFrame: 21 days (approximately three weeks of treatment)
measure: Daily Painkiller Usage
timeFrame: 21 days (approximately three weeks of treatment)
measure: Complication Rate
timeFrame: 21 days (approximately three weeks of treatment)
Secondary outcomes:
measure: Number of Participants Who Smoke
timeFrame: At baseline (pre-surgery)
measure: Number of Participants with Alcohol Consumption
timeFrame: At baseline (pre-surgery)
measure: Dietary Habits
timeFrame: At baseline (pre-surgery)
measure: Sleep Patterns
timeFrame: 21 days (approximately three weeks of treatment)
measure: Nutritional Status
timeFrame: 21 days (approximately three weeks of treatment)
measure: HbA1C Levels to Assess Diabetes Control
timeFrame: 21 days (approximately three weeks of treatment)
measure: BUN levels
timeFrame: At baseline and Day 21 after surgery
measure: eGFR values
timeFrame: At baseline and Day 21 after surgery
measure: creatinine levels
timeFrame: At baseline and Day 21 after surgery
measure: AST (SGOT) levels
timeFrame: At baseline and Day 21 after surgery
measure: ALT (SGPT) levels
timeFrame: At baseline and Day 21 after surgery
measure: Total Bilirubin levels
timeFrame: At baseline and Day 21 after surgery
measure: Direct Bilirubin levels
timeFrame: At baseline and Day 21 after surgery
Other outcomes:
Locations:
Study officials:
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