Estudio comparativo entre la esfinterotomía lateral interna y el gel de diltiazem 2% en el tratamiento de la fisura anal crónicaresultados a corto y largo plazo

Laburpena

Introduction. There is sufficient evidence on the treatment of chronic anal fissure with diltiazem 2% gel (sphincterotomy chemistry), however there are few studies that compare this treatment with surgical sphincterotomy (lateral internal sphincterotomy), short and long-term outcomes. Objective. The purpose of this study is to compare short and long-term results in terms of efficacy, recurrence, adverse effects, complications and costs, between sphincterotomy and diltiazem 2% gel in the treatment of chronic anal fissure, in two homogeneous populations. Patients and Method. We studied patients diagnosed of chronic anal fissure in our hospital which met the criteria for inclusion and exclusion, during the period January 2008 to December 2013 (6 years). Two groups, the first with farmacological treatment and the second group with surgical treatment were established. Patients in the first group we used a formulation of Diltiazem gel 2%, in three daily applications for eight weeks. In case of inefficiency, recurrence or abandonment of treatment due to adverse effect a sphincterotomy was indicated. The second group consisted of patients treated with surgical sphincterotomy. Controls at 4 and 8 weeks of treatment were established. Subsequently an annually telephone survey was conducted or face control if considered necessary. Groups were compared using the X2 test for qualitative variables and the Student test for quantitative variables. Results. We analyzed 265 patients (137 women) in the Diltiazem group with a mean age of 46.7 (18-65) years, with 184.2 variance and standard deviation 13.6. Location of the fissure: posterior 96%, anterior 3% and lateral 1%. All patients had pain, 231 bleeding and 198 stinging and itching. Average duration of symptoms 17.5 (5-60) months. Of the 265 patients, 174 (65.7%) patients were cured after 8 weeks of treatment. Thirty-one (11.7%) patients experienced adverse effects related to treatment, of which 7 (2.6%) discontinued therapy because of this. 46 patients were excluded, because they couldn ́t be contacted for follow-up (lost patients). After a mean follow up of 31 (8-72) months, 43 recurrences were detected (16.2%). No cases of incontinence were detected. The median time to recurrence after treatment was 5.7 (2.5 to 32) months. Most recurrences (81.4%) occurred in the first 12 months following treatment. The 174 cured patients required an average of 1.4 (1- 5) dispensations of Diltiazem 2 % gel, with an average cost per patient of 40.2 (28.7 to 143.5) euros. In the surgical group, we analized 176 patients (81mujeres), mean age 46 (19-65) years. Location of the fissure: posterior 95%, anterior 4.5% and lateral 0.5%. All patients had pain, 80,6% bleeding and 74,7% stinging and itching. Average duration of symptoms 19.7 (1-72) months. Average hospital stay one day and range 0-6 days. Of the 176 patients, 152 (96.2%) patients were cured, most of them after 3 (2-6) weeks of treatment. Fifteen (9.9%) patients experienced complications related to sphincterotomy, among which, 6 (3.9%) cases of reversible incontinence we observed . 18 patients were excluded, because they couldn ́t be contacted for follow-up (lost patients). After a mean follow up of 34.3 (10-72) months, 12 (8.3%) recurrences were detected. The median time of recurrence after treatment was 18.2 (2-60) months. Most (75%) recurrences occurred in the first two years. The average cost per process was 1838.5 (1711-1966) euros. There were no significant differences (p> 0.05) between groups related to age, sex, location of the fissure, symptoms, mean duration of symptoms and associated disease. Statistically significant difference (p <0.05) was found between the groups in fairy effectiveness of treatment, response time, recurrence, time to recurrence, incontinence and cost. Conclusion. The treatment of chronic anal fissure with diltiazem 2% gel is an effective, safe, easy to administer, reversible, economic and with slight adverse effects, however effectiveness is lower and recurrence rate is higher, with respect to the surgical sphincterotomy, but this is burdened by the possibility of alterations in continence and a higher cost.