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New treatment option for Chronic Anal Fissure
Official title Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure
ClinicalTrials.gov ID: NCT07520552
What this study is testing
- What it's testing
- This prospective randomized controlled trial compares three lateral internal sphincterotomy (LIS) techniques in patients with chronic anal fissure refractory to medical treatment: (1) Spasm-Controlled LIS (serial small sphincterotomies using an anal calibrator until 30 mm anal caliber is achieved, under local anesthesia plus sedation), (2) LIS up to the Fissure Apex (spinal or general anesthesia), and (3) LIS up to the Dentate Line (spinal or general anesthesia). The primary outcomes are fissure healing rate and fecal incontinence incidence at 12 months, assessed using the Wexner Incontinence Score.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- Diagnosis of chronic anal fissure (duration ≥8 weeks)
- Failure to heal after at least 6 weeks of appropriate medical treatment (topical agents, fiber supplementation, sitz baths)
- Complete preoperative fecal continence (Wexner Incontinence Score = 0)
- Primary anal fissure (posterior or anterior midline location)
You likely can't join if
- Any degree of preoperative fecal incontinence
- Secondary anal fissure (associated with Crohn's disease, tuberculosis, HIV, syphilis, or other systemic conditions)
- Previous anal sphincter surgery
- History of obstetric sphincter injury
- Active anorectal infection (abscess or fistula)
- Pregnancy or breastfeeding
See the full eligibility criteria
- Age 18 years or older
- Diagnosis of chronic anal fissure (duration ≥8 weeks)
- Failure to heal after at least 6 weeks of appropriate medical treatment (topical agents, fiber supplementation, sitz baths)
- Complete preoperative fecal continence (Wexner Incontinence Score = 0)
- Primary anal fissure (posterior or anterior midline location)
- Written informed consent
- Any degree of preoperative fecal incontinence
- Secondary anal fissure (associated with Crohn's disease, tuberculosis, HIV, syphilis, or other systemic conditions)
- Previous anal sphincter surgery
- History of obstetric sphincter injury
- Active anorectal infection (abscess or fistula)
- Pregnancy or breastfeeding
- Uncorrectable coagulopathy or current anticoagulant use
- Inability to cooperate with study procedures or attend follow-up visits
The study team makes the final eligibility decision.
Where it's taking place
- Çanakkale, Çanakkale, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Çanakkale, Çanakkale, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.