Ultrasound Assessment After Surgery for Chronic Anal Fissure
ConditionAnal Fissure Chronic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Clínico Universitario de Valencia
About this trial
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 (LIS) 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Fissure Healing Without Persistence or Recurrence
Fissure status will be assessed clinically and classified as healed without recurrence or as persistent or recurrent. Healing is defined as complete epithelialisation with no visible residual fissure and resolution of fissure-related pain and bleeding. Persistence is defined as failure to achieve healing by 3 months. Recurrence is defined as the reappearance of a symptomatic fissure after documented healing and an intervening symptom-free period.
Time frame
From surgery to 12 months after surgery2
Change in Anal Continence Assessed Using the Jorge-Wexner Score
Change from baseline to 12 months in the Jorge-Wexner score. The score ranges from 0 to 20, with higher scores indicating worse anal incontinence. The analysis will assess postoperative deterioration in continence. The threshold used to define clinically relevant deterioration will be prespecified in the statistical analysis plan before database lock.
Time frame
12 monthsSecondary outcomes
1
Health-Related Quality of Life Assessed Using the SF-36
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36) before surgery and during the first postoperative year. The questionnaire provides scores for eight health domains, transformed to a scale from 0 to 100, with higher scores indicating better health-related quality of life. Baseline scores will describe the burden associated with chronic anal fissure, and changes from baseline will be evaluated at each follow-up visit.
Time frame
Baseline and 3, 6, and 12 months after surgery2
Fissure Recurrence After Lateral Internal Sphincterotomy
Number and percentage of participants who develop fissure recurrence during the first postoperative year. Recurrence is defined as the reappearance of a symptomatic anal fissure after previously documented healing and an intervening symptom-free period.
Time frame
From documented healing to 12 months after surgery3
Early Change in Anal Continence Assessed Using the Jorge-Wexner Score
Change from baseline in the Jorge-Wexner score at 3 and 6 months after surgery. The score ranges from 0 to 20, with higher scores indicating worse anal incontinence. These assessments will describe the early postoperative course of anal continence before the primary 12-month assessment.
Time frame
Baseline to 3, 6 and 12 months after surgery4
Extent of Anal Sphincter Injury Assessed Using Three-Dimensional Endoanal Ultrasonography
Postoperative sphincter anatomy will be evaluated using three-dimensional endoanal ultrasonography. Measurements will include total internal anal sphincter length, sphincterotomy defect length, proportion of the internal sphincter divided, completeness of division, angle of separation between the divided sphincter ends, and the presence and location of any external anal sphincter defect. The proportion divided will be calculated as defect length divided by total internal sphincter length and expressed as a percentage.
Time frame
3 months after surgerySponsors and contacts
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Source ClinicalTrials.gov