Impact of Surgical Timing on Anal Fistula Outcomes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 3 trial groupsGroup A: Group A: Symptom Onset ≤ 3 Months
Group B: Group B: Symptom Onset 3-6 Months
Group C: Group C: Symptom Onset > 6 Months
Trial outcomes
Primary outcomes
1
Clinical Healing Rate
The percentage of patients achieving complete epithelialization with no active discharge or drainage, as assessed by digital rectal examination and proctoscopy.
Time frame
12 months post-surgery2
Recurrence Rate
The percentage of patients experiencing a reappearance of symptoms with a confirmed fistula on clinical examination or imaging.
Time frame
Within 12 months post-surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: