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Can a laser seal fistulas without major surgery?

NCT ID NCT07797842

Disease control Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether a minimally invasive laser procedure can close low perianal fistulas as effectively as traditional open surgery. Adults with a primary low perianal fistula are randomly assigned to receive either laser closure or open fistulectomy. Researchers track healing rates, pain, recovery time, and quality of life over six months to see which approach offers better outcomes with fewer risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fistula-tract laser closure (FiLaC) using a 1470 nm diode laser, compared with open fistulectomy surgery
What this could lead to
If laser closure works as well as open surgery, it could offer a less painful, faster-recovering option for people with low perianal fistula, with a lower risk of sphincter injury.
What could go wrong
This is a small, early-stage trial, and laser closure may not heal fistulas as reliably as the standard open surgery. There is also a risk of recurrence or complications with either procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients aged 18 years and above. * Diagnosis of primary (non-recurrent) low perianal fistula (intersphincteric or low transsphincteric involving less than one-third of the external sphincter) confirmed by clinical examination. * Fistula tract anatomy confirmed by preoperative endoanal ultrasound (EAUS) and/or pelvic MRI. * Fit for surgery under spinal or general anesthesia. * Willing and able to provide written informed consent. Exclusion Criteria: * Complex or high perianal fistulae (suprasphincteric, extrasphincteric, or involving more than one-third of the external sphincter). * Recurrent or previously operated perianal fistulae. * Crohn's disease or other inflammatory bowel disease-associated fistulae. * Active anorectal sepsis or undrained abscess at the time of enrollment. * Immunocompromised patients (e.g., HIV/AIDS, long-term systemic corticosteroid therapy, post-organ transplantation). * Pre-existing fecal incontinence (baseline Wexner Continence Score \> 5). * Pregnant or breastfeeding females. * Known bleeding disorders or therapeutic anticoagulation that cannot be temporarily safely discontinued. * History of prior pelvic irradiation. * Inability or unwillingness to comply with the postoperative follow-up protocol.

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Conditions

The condition(s) this trial relates to.

anal fistula Encopresis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fistula in ano Low perianal fistula Perianal fistula

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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