Ultrasound-based look at how much sphincter is cut during LIS for chronic anal fissure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study will enroll 66 adults undergoing open or closed lateral internal sphincterotomy for chronic anal fissure. Three-dimensional endoanal ultrasound will measure the extent of sphincter division, and participants will be followed for 12 months with assessments before surgery and at 3, 6, and 12 months after. The goal is to see if greater or lesser division correlates with fissure healing and changes in continence, including quality of life. The surgical technique is chosen by the treating surgeon and not by the researchers, reflecting real-world practice. No intervention is assigned by the study beyond measurement and follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Francisco Castillejos-Ibáñez
  Valencia, Spain Recruiting

Study contacts

• Study coordinator: Francisco Castillejos-Ibáñez, MD
• Email: casifra19@gmail.com
• Phone: +34671286736

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.