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Randomized Controlled Trial
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J Korean Soc Coloproctol. 2000;16(6):360-364.
- Topical Glyceryl Trinitrate (GTN) Versus Conservative Treatment (CT) in Chronic Anal Fissure: Prospective and Randomized Study.
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Lee, Kwang Real , Cho, Kyung Ah , Hwang, Do Yeon , Kim, Kuhn Uk , Park, Weon Kap , Yoon, Seo Gu , Kim, Hyun Shig , Lee, Jong Kyun
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1Department of Surgery, Song Do Colorectal Hospital, Seoul, Korea. kreal@channeli.net
- Abstract
- PURPOSE: This study was designed to compare the effect of treatment using glyceryl trinitrate (GTN) ointment with that of conservative treatment (CT) on chronic anal fissure.
METHODS
As a preliminary study, maximal resting pressures of the anal canal were checked in 13 patients having chronic anal fissure before and 10 minutes after application of 0.2% GTN ointment. As the study groups, 59 patients having chronic anal fissure were randomly allocated to the GTN and the placebo groups. All the patients in both groups were given oral analgesics, sedatives, and bulk-forming agents.
They had applied 0.2% GTN ointment or a placebo ointment three times a day to their perianal skin. Maximal resting pressures of the anal canal were checked at the beginning and at the endpoint of the treatment period which continued for 6 weeks. If there was complete healing of the fissure in the middle of the treatment, the treatment was stopped.
Sixteen patients were lost during the study.
RESULTS
Among the rest, 22 and 21 patients were included in the GTN group and the placebo group, respectively. The maximal resting pressure decreased significantly in all groups (p<0.05). The healing rates, the recurrence rates, and the operation rates were not significantly different between the GTN group and placebo group (p>0.05).
CONCLUSION: The effect of GTN on the symptomatic relief and results of treatment in patients having chronic anal fissure is not superior to that of conservative treatment.
Keywords :Anal fissure;Glyceryl trinitrate;Conservative treatment
