Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure

Condition(s) studied

Investigational drug(s) / intervention(s)

Spasm-Controlled Lateral Internal Sphincterotomy: Serial small open sphincterotomies under local anesthesia plus IV sedation using an anal calibrator until anal caliber of 30 mm is achieved.

Lateral Internal Sphincterotomy up to Fissure Apex: Open LIS extended to the proximal end of the fissure under spinal or general anesthesia.

Lateral Internal Sphincterotomy up to Dentate Line: Open LIS extended to the level of the dentate line under spinal or general anesthesia.

Study summary

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. Secondary outcomes include postoperative pain (VAS), recurrence rate, patient satisfaction, and complications. A total of 150 patients (50 per group) will be enrolled and followed for 12 months.

Eligibility

Primary outcome measure(s)

• Fissure Healing Rate — 12 months
  Complete epithelialization of the anal fissure with no symptoms at 12 months postoperatively, assessed by clinical examination.
• Fecal Incontinence Incidence — 12 months
  Incidence of de novo fecal incontinence assessed using the Wexner (Cleveland Clinic) Incontinence Score. A score increase of ≥1 point from preoperative baseline is defined as de novo incontinence.

Trial sites (1)

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