PURPOSE: Although there is enthusiasm for nonoperative management of anal fissures, most trials have been of short duration (6-8 weeks) and long-term outcome is unknown. The purpose of this study was to assess long-term outcome in two cohorts of patients who had participated in a randomized, controlled trial to compare the effectiveness of topical nitroglycerin with internal sphincterotomy in the treatment of chronic anal fissure. METHODS:Between February 1997 and October 1998, 82 patients with chronic anal fissure were accrued and randomized to 0.25 percent nitroglycerin ointment t.i.d. or lateral internal sphincterotomy. In 2004, a telephone survey of trial participants was conducted to determine symptom recurrence, the need for further medical and/or surgical treatment, and patient satisfaction. Furthermore, patients were assessed for symptoms of fecal incontinence using the Jorge and Wexner Fecal Incontinence Score and the Fecal Incontinence Quality of Life questionnaire. RESULTS: Overall, 51 of the original 82 patients (62 percent, 27 nitroglycerin, 24 lateral internal sphincterotomy) completed our survey. Mean follow-up was 79 (+/-1) months. Sphincterotomy patients were less likely to have experienced fissure symptoms within the past year (0 vs. 41 percent; P = 0.0004) and were less likely to require subsequent surgical treatment (0 vs. 59 percent; P < 0.0001) than patients treated with nitroglycerin. Patients in the lateral internal sphincterotomy group were more likely to say that they were "very" or "moderately" satisfied with their treatment (100 vs. 56 percent; P = 0.04) and that they would choose the same treatment again (92 vs. 63 percent; P = 0.02) than patients in the nitroglycerin group. Finally, the fecal incontinence and fecal incontinence quality of life scores at six-year follow-up were similar in both groups. CONCLUSIONS: After six years of follow-up, it seems that lateral internal sphincterotomy is a more durable treatment for chronic anal fissure compared with topical nitroglycerin therapy and does not compromise long-term fecal continence. Thus, sphincterotomy continues to be a good treatment for patients with chronic anal fissure.
RCT Entities:
PURPOSE: Although there is enthusiasm for nonoperative management of anal fissures, most trials have been of short duration (6-8 weeks) and long-term outcome is unknown. The purpose of this study was to assess long-term outcome in two cohorts of patients who had participated in a randomized, controlled trial to compare the effectiveness of topical nitroglycerin with internal sphincterotomy in the treatment of chronic anal fissure. METHODS: Between February 1997 and October 1998, 82 patients with chronic anal fissure were accrued and randomized to 0.25 percent nitroglycerin ointment t.i.d. or lateral internal sphincterotomy. In 2004, a telephone survey of trial participants was conducted to determine symptom recurrence, the need for further medical and/or surgical treatment, and patient satisfaction. Furthermore, patients were assessed for symptoms of fecal incontinence using the Jorge and Wexner Fecal Incontinence Score and the Fecal Incontinence Quality of Life questionnaire. RESULTS: Overall, 51 of the original 82 patients (62 percent, 27 nitroglycerin, 24 lateral internal sphincterotomy) completed our survey. Mean follow-up was 79 (+/-1) months. Sphincterotomy patients were less likely to have experienced fissure symptoms within the past year (0 vs. 41 percent; P = 0.0004) and were less likely to require subsequent surgical treatment (0 vs. 59 percent; P < 0.0001) than patients treated with nitroglycerin. Patients in the lateral internal sphincterotomy group were more likely to say that they were "very" or "moderately" satisfied with their treatment (100 vs. 56 percent; P = 0.04) and that they would choose the same treatment again (92 vs. 63 percent; P = 0.02) than patients in the nitroglycerin group. Finally, the fecal incontinence and fecal incontinence quality of life scores at six-year follow-up were similar in both groups. CONCLUSIONS: After six years of follow-up, it seems that lateral internal sphincterotomy is a more durable treatment for chronic anal fissure compared with topical nitroglycerin therapy and does not compromise long-term fecal continence. Thus, sphincterotomy continues to be a good treatment for patients with chronic anal fissure.