Anal Fistula SurgeryNCT07482241
Impact of Surgical Timing on Anal Fistula Outcomes
An observational study of Anal Fistula Surgery and Anal Fistula, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula Surgery, Anal Fistula, Surgery Timing
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: Does the Duration Between Symptom Onset and Surgical Intervention Affect the Outcomes in Patients With Anal Fistula?
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.
Read more
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.
Read the detailed description
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:
- Temporal Measurement: The primary exposure variable is the precise interval in days calculated by subtracting the documented symptom onset date from the surgery date. This onset date is captured from initial outpatient clinic notes, emergency department records, or primary care referrals.
- Preoperative Assessment: Magnetic Resonance Imaging (MRI) will be used to classify the fistula's complexity using Park's classification extended by St. James University Hospital, and the external opening location will be documented using Goodsall's rule.
- Intraoperative Protocol: Following an examination under anesthesia (EUA) with tract probing, the surgical intervention will be performed. Researchers will document the procedure type, operative time, estimated blood loss, extent of sphincterotomy, and any intraoperative findings.
- Postoperative Monitoring: Pain will be assessed using a 10 cm Visual Analog Scale (VAS) at 6 hours, 12 hours, 24 hours, 1 week, 2 weeks, and at clinic visits at 1, 3, 6, and 12 months. Fecal incontinence will be evaluated using the Wexner Cleveland Clinic Fecal Incontinence Score, with a clinically significant deterioration defined as a 2-point or greater increase. Clinical healing will be verified by digital rectal exam and proctoscopy.
- Conditions
- Anal Fistula Surgery, Anal Fistula, Surgery Timing
- Keywords
- Anal Fistula, Cryptoglandular Anal Fistula, Fistula in Ano, Anorectal Fistula
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Healing Rate
The percentage of patients achieving complete epithelialization with no active discharge or drainage, as assessed by digital rectal examination and proctoscopy.
Measured: 12 months post-surgery
Recurrence Rate
The percentage of patients experiencing a reappearance of symptoms with a confirmed fistula on clinical examination or imaging.
Measured: Within 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Fistula SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Othman Anter, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482241
- Sponsor's protocol ID
- Timing of Anal Fistula Surgery
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Duration Between Symptom Onset and Surgical Intervention Affect the Outcomes in Patients With Anal Fistula?
- ClinicalTrials.gov ID
- NCT07482241
- Acronym / sponsor ID
- Timing of Anal Fistula Surgery
- Conditions
- Anal Fistula Surgery, Anal Fistula, Surgery Timing
- Keywords
- Anal Fistula, Cryptoglandular Anal Fistula, Fistula in Ano, Anorectal Fistula
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Temporal Measurement: The primary exposure variable is the precise interval in days calculated by subtracting the documented symptom onset date from the surgery date. This onset date is captured from initial outpatient clinic notes, emergency department records, or primary care referrals.
- Preoperative Assessment: Magnetic Resonance Imaging (MRI) will be used to classify the fistula's complexity using Park's classification extended by St. James University Hospital, and the external opening location will be documented using Goodsall's rule.
- Intraoperative Protocol: Following an examination under anesthesia (EUA) with tract probing, the surgical intervention will be performed. Researchers will document the procedure type, operative time, estimated blood loss, extent of sphincterotomy, and any intraoperative findings.
- Postoperative Monitoring: Pain will be assessed using a 10 cm Visual Analog Scale (VAS) at 6 hours, 12 hours, 24 hours, 1 week, 2 weeks, and at clinic visits at 1, 3, 6, and 12 months. Fecal incontinence will be evaluated using the Wexner Cleveland Clinic Fecal Incontinence Score, with a clinically significant deterioration defined as a 2-point or greater increase. Clinical healing will be verified by digital rectal exam and proctoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Healing Rate
Time frame: 12 months post-surgery
The percentage of patients achieving complete epithelialization with no active discharge or drainage, as assessed by digital rectal examination and proctoscopy.
Recurrence Rate
Time frame: Within 12 months post-surgery
The percentage of patients experiencing a reappearance of symptoms with a confirmed fistula on clinical examination or imaging.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula Surgery and Anal Fistula, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Healing Rate (time frame: 12 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.