How much muscle should surgeons cut? ultrasound maps anal fissure surgery
NCT ID NCT07809711
First seen Sep 09, 2026 · Last updated Sep 18, 2026 · Updated 3 times
Summary
Chronic anal fissure is a painful tear in the anal canal that often needs surgery when creams and other treatments fail. Surgeons perform lateral internal sphincterotomy by cutting part of the internal anal sphincter muscle, but how much muscle to divide is debated. This observational study follows 66 adults before surgery and at 3, 6, and 12 months after. Researchers use 3D endoanal ultrasound to measure the amount of muscle divided and check whether that measurement relates to fissure healing and changes in bowel control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If the study links a specific amount of muscle division to good healing and fewer continence problems, surgeons could tailor the operation to each patient.
- What could go wrong
- This is an observational study of 66 people at one hospital, so it can show patterns but not prove cause and effect. Ultrasound measurements may not capture every factor that affects healing or bowel control.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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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.
Who is studied
Adults evaluated in the colorectal outpatient clinics of Hospital Clínico Universitario de Valencia with primary chronic anal fissure that has not responded to 6-8 weeks of conservative treatment and who are scheduled to undergo open or closed lateral internal sphincterotomy as part of routine clinical care. Consecutive potentially eligible patients will be assessed by a colorectal surgeon and invited to participate. Only participants who meet the eligibility criteria and provide written informed consent will be enrolled. Healthy volunteers will not be included.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age 18 years or older. * Primary chronic anal fissure, defined as symptoms lasting more than 6-8 weeks and failure of complete conservative treatment, irrespective of the presence of anatomical signs of chronicity. * Clinical indication for open or closed LIS. * Capacity to understand the study, complete the questionnaires and provide written informed consent. Exclusion Criteria: * Acute anal fissure of less than 6-8 weeks' duration. * Secondary anal fissure associated with Crohn's disease, ulcerative colitis, tuberculosis, HIV infection, anal malignancy or another identified secondary cause. * Neurological or neuromuscular disease that may affect continence. * Moderate or severe anal incontinence at baseline. * Concomitant anorectal disease requiring another procedure, including symptomatic haemorrhoids or anal fistula. * Previous or current circumstances that prevent reliable completion of patient-reported measures. * Anticipated inability to attend postoperative follow-up. * Incomplete conservative treatment before the decision for surgery. * Participants may withdraw consent at any time without affecting their care. Investigators may discontinue study follow-up if eligibility was incorrectly assigned or if a clinical event prevents completion of study procedures. Data collected before withdrawal will be handled in accordance with the consent form and applicable legislation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Francisco Castillejos-Ibáñez
RECRUITINGValencia, 46010, Spain
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