Clinical, manometric, and ultrasonographic results of pneumatic balloon dilatation vs. lateral internal sphincterotomy for chronic anal fissure: a prospective, randomized, controlled trial.

PURPOSE: This prospective, randomized, controlled trial was designed to compare the clinical, functional, and morphologic results of pneumatic balloon dilatation with lateral internal sphincterotomy for the treatment of chronic anal fissure. METHODS: All patients with symptomatic chronic anal fissure were randomly assigned to pneumatic balloon dilatation or lateral internal sphincterotomy and invited to complete a standardized questionnaire inquiring about their symptoms. Anal ultrasonography and anal manometry were performed before and six months after surgery. A proctologic examination was performed between the fifth and sixth postoperative weeks. Anal continence, scored by using a validated continence grading scale, was evaluated preoperatively at 1 and 6 weeks and at 12 and 24 months. RESULTS: Fifty-three patients, who satisfied selection criteria, were enrolled in the trial. Four patients (7.5 percent) were lost to follow-up. Twenty-four patients (11 males; mean age, 42 +/- 8.2 years) underwent pneumatic balloon dilatation and 25 patients (10 males; mean age, 44 +/- 7.3 years) underwent lateral internal sphincterotomy. Fissure-healing rates were 83.3 percent in the pneumatic balloon dilatation and 92 percent in the lateral internal sphincterotomy group. Recurrent anal fissure was observed in one patient (4 percent) after lateral internal sphincterotomy. At anal manometry, mean resting pressure decrements obtained after pneumatic balloon dilatation and lateral internal sphincterotomy were 30.5 and 34.3 percent, respectively. After pneumatic balloon dilatation, anal ultrasonography did not show any significant sphincter damage. At 24-month follow-up, the incidence of incontinence, irrespective of severity, was 0 percent in the pneumatic balloon dilatation group and 16 percent in the lateral internal sphincterotomy group (P < 0.0001). CONCLUSIONS: As lateral internal sphincterotomy, pneumatic balloon dilatation grants a high anal fissure-healing rate but with a statistically significant reduction in postoperative anal incontinence.