Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate if the amount of time a person experiences symptoms of an anal fistula before having surgery affects their surgical outcomes and recovery.
An anal fistula is a chronic condition that typically requires surgery to heal properly. In routine clinical practice, many patients experience a significant delay before getting surgery due to a variety of reasons, such as under-reporting symptoms, misdiagnosis, or prolonged conservative treatments. Doctors want to understand if this delay in surgical intervention allows ongoing infection and scarring to complicate the surgery and worsen the patient's recovery.
To investigate this, researchers will observe 90 adult patients who are undergoing definitive surgery for a primary anal fistula. The participants will be divided into three groups based on how long they had symptoms before their operation:
3 months or less Between 3 and 6 months More than 6 months
The main goal of the study is to compare these groups to see how many patients achieve complete clinical healing and how many experience a recurrence (the fistula returning) within 12 months after the surgery. Additionally, the study will track secondary outcomes, including how long it takes the wound to heal completely, any postoperative complications, changes in bowel control (fecal incontinence), pain resolution, and the patient's overall postoperative quality of life. The findings will help inform both doctors and patients on the optimal timing for anal fistula surgery.
This prospective cohort study evaluates whether the duration from symptom onset to surgical intervention influences key clinical outcomes in anal fistula.
The estimated required sample size is 90 patients, distributed evenly with 30 patients in each of the three groups. This sample was calculated using G*power software, assuming an alpha of 0.05, a power of 0.80, and a hypothesized medium effect size difference (0.3) between the groups using a one-way ANOVA test.
Study Procedures and Data Collection:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Symptom Onset ≤ 3 Months | Patients undergoing definitive surgical intervention for primary cryptoglandular anal fistula 3 months or less from their initial symptom onset. The specific surgical procedure is performed according to surgeon preference. | ||
| Group B: Symptom Onset 3-6 Months | Patients undergoing definitive surgical intervention for primary cryptoglandular anal fistula between 3 and 6 months from their initial symptom onset. The specific surgical procedure is performed according to surgeon preference. | ||
| Group C: Symptom Onset > 6 Months | Patients undergoing definitive surgical intervention for primary cryptoglandular anal fistula more than 6 months after their initial symptom onset. The specific surgical procedure is performed according to surgeon preference. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Healing Rate | The percentage of patients achieving complete epithelialization with no active discharge or drainage, as assessed by digital rectal examination and proctoscopy. | 12 months post-surgery |
| Recurrence Rate | The percentage of patients experiencing a reappearance of symptoms with a confirmed fistula on clinical examination or imaging. | Within 12 months post-surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The study population consists of adult patients (aged 18 years or older) who are diagnosed with primary cryptoglandular anal fistula. Diagnosis must be confirmed by clinical examination and preoperative MRI. These patients will be undergoing definitive surgical intervention at the Department of Surgery in Assiut University Hospital between 2026 and 2028. The population excludes pregnant women, individuals with recurrent fistulas or prior surgical intervention for the same fistula, and those whose fistulas are due to specific conditions like Crohn's disease, tuberculosis, malignancy, trauma, radiation, or obstetrical injury.
Not provided
| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |