Endoanal ultrasonographic assessment after lateral internal sphincterotomy for chronic anal fissure: protocol for a prospective longitudinal cohort study.
NCT ID NCT07809711
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
Chronic anal fissure is a painful tear in the lining of the anal canal that may not heal with medication or other non-surgical treatments. Lateral internal sphincterotomy is a commonly used surgical treatment. However, the amount of internal anal sphincter muscle divided during surgery may affect both fissure healing and the risk of impaired bowel control. The purpose of this prospective observational study is to assess whether the extent of internal anal sphincter division, measured using three-dimensional endoanal ultrasound, is associated with fissure healing and changes in anal continence during the first year after surgery. The study will include 66 adults with chronic anal fissure undergoing open or closed lateral internal sphincterotomy as part of their usual clinical care. The surgical technique will be selected by the treating clinical team and will not be assigned by the researchers. Participants will be assessed before surgery and at 3, 6, and 12 months after surgery. At the 3-month visit, they will undergo two-dimensional and three-dimensional endoanal ultrasound. Two independent observers will separately review the stored ultrasound images. Follow-up assessments will evaluate fissure healing or recurrence, bowel control, faecal soiling, pain, bleeding, postoperative complications, and quality of life. The findings may help identify the extent of sphincter division that provides effective fissure healing while limiting the risk of postoperative anal incontinence.
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.
- Participants
-
About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2024
- Expected to finish
-
May 2028
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.
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
-
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 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Anal fissure chronic are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Francisco Castillejos-Ibáñez
RECRUITINGValencia, 46010, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.