Optimal treatment duration of glyceryl trinitrate for chronic anal fissure: results of a prospective randomized multicenter trial
| Autor: | F. Arcanà, Donato F. Altomare, Vincenzo J. Greco, Antonio Amato, Luigi Basso, P. De Nardi, I. De Stefano, A. Pulvirenti D’Urso, Leoluca Vasapollo, G. Gagliardi, F. La Torre, A. Bove, Domenico Aiello, A. Pascariello, Danilo Cafaro |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Anal pain Time Factors Administration Topical Chronic anal fissure anal fissure nitroglycerin anal pain nitric oxide Risk Assessment Severity of Illness Index Drug Administration Schedule law.invention Nitroglycerin Randomized controlled trial law Reference Values Multicenter trial Severity of illness medicine Humans Prospective Studies Prospective cohort study Pain Measurement Anal fissure Analysis of Variance Wound Healing Dose-Response Relationship Drug business.industry Gastroenterology Nitric oxide Middle Aged medicine.disease Colorectal surgery Surgery Treatment Outcome Anesthesia Chronic Disease cardiovascular system Female Original Article Fissure in Ano business circulatory and respiratory physiology Abdominal surgery Follow-Up Studies |
| Zdroj: | Techniques in Coloproctology |
| ISSN: | 1128-045X |
| Popis: | Background Chronic anal fissure (CAF) is a painful condition that is unlikely to resolve with conventional conservative management. Previous studies have reported that topical treatment of CAF with glyceryl trinitrate (GTN) reduces pain and promotes healing, but optimal treatment duration is unknown. Methods To assess the effect of different treatment durations on CAF, we designed a prospective randomized trial comparing 40 versus 80 days with twice daily topical 0.4% GTN treatment (Rectogesic®, Prostrakan Group). Chronicity was defined by the presence of both morphological (fibrosis, skin tag, exposed sphincter, hypertrophied anal papilla) and time criteria (symptoms present for more than 2 months or pain of less duration but similar episodes in the past). A gravity score (1 = no visible sphincter; 2 = visible sphincter; 3 = visible sphincter and fibrosis) was used at baseline. Fissure healing, the primary endpoint of the study, maximum pain at defecation measured with VAS and maximum anal resting pressure were assessed at baseline and at 14, 28, 40 and 80 days. Data was gathered at the end of the assigned treatment. Results Of 188 patients with chronic fissure, 96 were randomized to the 40-day group and 92 to the 80-day group. Patients were well matched for sex, age, VAS and fissure score. There were 34 (19%) patients who did not complete treatment, 18 (10%) because of side effects. Of 154 patients who completed treatment, 90 (58%) had their fissures healed and 105 (68%) were pain free. There was no difference in healing or symptoms between the 40- and the 80-day group. There was no predictor of fissure healing. A low fissure gravity score correlated with increased resolution of pain (P |
| Databáze: | OpenAIRE |
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