Impact of Surgical Timing on Anal Fistula Outcomes (NCT07482241) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Surgical Timing on Anal Fistula Outcomes
90 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 years or older diagnosed with primary cryptoglandular anal fistula confirmed by clinical examination and preoperative imaging (MRI).
* Patients who will be undergoing definitive surgical intervention for anal fistula at Assiut University Hospital between 2026 and 2028.
* Complete medical records available, including documented symptom onset date (defined as first reported perianal pain, swelling, or discharge) and surgery date.
* Minimum postoperative follow-up of 12 months, with clinical assessment data on healing and recurrence.
Exclusion Criteria:
* Fistulas due to Crohn's disease, tuberculosis, malignancy, trauma, radiation, or obstetrical injury.
* Pregnant women.
* Recurrent anal fistulas or those with prior surgical intervention for the same fistula.
* Incomplete records or loss to follow-up before 6 months postoperatively.
* Patients with comorbidities precluding surgery (e.g., uncontrolled coagulopathy or active systemic infection).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.