An observational study in Anal Fistula Surgery, sponsored by Taichung Veterans General Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Taichung Veterans General Hospital · Observational
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:
169 studies on the registry are indexed under Rectal Fistula; 45 are open to participants now.
This study's planned enrollment of 600 is above the median of 85 across 46 observational studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →Taichung Veterans General Hospital is the lead sponsor of 175 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing fistula surgery at Taichung Veterans General Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients using New Epi epidermal growth factor who are over 18 years old, confirmed to require fistula surgery, without significant surgical contraindications, able to understand and willing to participate in the study, and willing to sign the informed consent form.
Other: NewEpi Plus Liquid Wound Dressing
Patients receiving standard wound care who are over 18 years old, confirmed to require fistula surgery, without significant surgical contraindications, able to understand and willing to participate in the study, and willing to sign the informed consent form.
Other: standard wound care
1. Hold the spray nozzle 7-10 cm away from the wound. Apply the product evenly over the wound, with a dosage of one spray (0.1 ml) per 10x10 cm² of wound area. 2. Wait for 2 minutes. It is not necessary to wait until the solution is completely dry; you can proceed with applying ointments and various types of dressings as directed by the physician. 3. Use once a day for 21 days. The frequency of use can be adjusted according to the physician\'s instructions.
The standard wound care protocol aims to provide comprehensive and systematic care for patients to ensure smooth healing of surgical wounds. These care measures include regular cleaning, disinfection, dressing changes, and continuous observation and assessment of the wound condition. Through strict aseptic techniques and scientific care procedures, standard wound care effectively reduces the risk of infection and promotes wound healing.
Wound Healing Speed
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)
Time frame: Day 7 and Day 21 after surgery
Postoperative Pain Assessment
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)
Time frame: 21 days (approximately three weeks of treatment)
Daily Painkiller Usage
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
Time frame: 21 days (approximately three weeks of treatment)
Complication Rate
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
Time frame: 21 days (approximately three weeks of treatment)
Number of Participants Who Smoke
1. Description: Smoking status will be recorded for all participants, categorizing them as current smokers, former smokers, or non-smokers. This will help assess whether smoking affects wound healing outcomes. 2. Unit of Measure: Number of participants
Time frame: At baseline (pre-surgery)
Number of Participants with Alcohol Consumption
1. Description: Alcohol consumption will be documented, with participants categorized based on their usage patterns (e.g., none, occasional, or frequent use). This measure will examine any correlation between alcohol use and wound healing. 2. Unit of Measure: Number of participants
Time frame: At baseline (pre-surgery)
Dietary Habits
1. Description:By recording dietary habits (vegetarian or non-vegetarian; dining out or home-cooked meals), we aim to determine whether diet affects the healing of surgical wounds. 2. Unit of Measure: Number of participants
Time frame: At baseline (pre-surgery)
Sleep Patterns
1. Description: By recording sleep times (before 10 PM, 10 PM to midnight, midnight to 2 AM, after 2 AM), we aim to determine whether sleep patterns affect the healing of surgical wounds. 2. Unit of Measure: Number of participants
Time frame: 21 days (approximately three weeks of treatment)
Nutritional Status
1. Description: Nutritional status will be assessed by tracking recent weight loss (more than 5% after surgry 3 weeks). This will evaluate the potential impact of poor nutrition on wound healing. 2. Unit of Measure: Number of participants
Time frame: 21 days (approximately three weeks of treatment)
HbA1C Levels to Assess Diabetes Control
1. Description: HbA1C levels will be measured to evaluate diabetes control and its influence on postoperative wound healing. 2. Unit of Measure: HbA1C (%)
Time frame: 21 days (approximately three weeks of treatment)
BUN levels
1. Description: The study will assess whether blood urea nitrogen (BUN) levels, measured through blood tests, have an impact on wound healing. 2. Unit of Measure: BUN (mg/dL)
Time frame: At baseline and Day 21 after surgery
eGFR values
1. The study will evaluate whether glomerular filtration rate (eGFR) values, assessed through blood tests, influence wound healing. 2. Unit of Measure: eGFR (mL/min/1.73 m²)
Time frame: At baseline and Day 21 after surgery
creatinine levels
1. The study will assess whether creatinine levels, evaluated through blood tests, have an impact on wound healing. 2. Unit of Measure: creatinine (mg/dL)
Time frame: At baseline and Day 21 after surgery
AST (SGOT) levels
1. Description: Liver function will be assessed by measuring AST (SGOT) . This evaluation will help determine whether liver function impacts wound healing. 2. Unit of Measure: U/L
Time frame: At baseline and Day 21 after surgery
ALT (SGPT) levels
1. Description: Liver function will be assessed by measuring ALT (SGPT) . This evaluation will help determine whether liver function impacts wound healing. 2. Unit of Measure: U/L
Time frame: At baseline and Day 21 after surgery
Total Bilirubin levels
1. Description: Liver function will be assessed by measuring Total Bilirubin. This evaluation will help determine whether liver function impacts wound healing. 2. Unit of Measure:mg/dL
Time frame: At baseline and Day 21 after surgery
Direct Bilirubin levels
1.Description: Liver function will be assessed by measuring Direct Bilirubin. This evaluation will help determine whether liver function impacts wound healing. 2. Unit of Measure:mg/dL
Time frame: At baseline and Day 21 after surgery
No study locations are listed for this record.
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 2024/9\~2026/6
Access criteria: Access Personnel: Internal research team members, limited to authorized personnel involved in the research project, such as the principal investigator, data analysts, and clinically relevant physicians. Access Content: Patient data, including age, gender, medical history, treatment details, and follow-up data. Access Method: Data will be accessed through a secure network system or database, requiring individual authorization and password protection. All individuals or teams accessing the data must sign a confidentiality agreement.
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Jun 2026, 21 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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