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CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
The natural history of symptomatic haemorrhoids.
In order to calculate the prognosis for a person who has developed a first episode of second degree haemorrhoids, 186 patients were randomly assigned to either no active treatment (expectant management) (n = 91) or rubber band ligation (n = 98) and reviewed every 6 months. The median follow-up period was 48 months in both groups with a range from 6-48 months in the banding group and from 18-48 months in the expectant management group. Rubber band ligation was performed at most three times with three weekly intervals. There were 6 treatment failures in the banding group in contrast to 31 in the expectant management group (p less than 0.01). The calculated recurrence rate by actuarial analysis among patients initially cured by rubber band ligation was 33% (95% confidence limits: 23-45) at four years and 61% (95% confidence limits: 48-74) in the expectant management group (p less than 0.05). It is concluded that rubber band ligation of symptomatic second degree haemorrhoids in up to three single treatments at three weekly intervals at the time of diagnosis significantly altered the prognosis without causing significant morbidity. However, 25% of the patients treated by expectant management never developed another episode during the four years observation time.
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