CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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A randomized controlled trial of rubber band ligation versus infra-red coagulation in the treatment of internal haemorrhoids.

OBJECTIVE: Despite the presence of numerous non-surgical therapies for the treatment of haemorrhoids, none of these therapies has clearly been proven to be superior. The effectiveness and patient tolerance of rubber band ligation (RBL) and infra-red coagulation (IRC) in the treatment of haemorrhoids was assessed.

DESIGN: Prospective randomized trial.

SETTING: Academic hospital (tertiary care).

PARTICIPANTS: A total of 133 consecutive patients (73 males, 60 females, mean age 48 years (range 19-82)) with internal haemorrhoids, and without concomitant anorectal disease, were randomized to rubber band ligation (RBL, n = 65) or infra-red coagulation (IRC, n = 68).

INTERVENTIONS: Rubber band ligation or infra-red coagulation was performed in one or more sessions with four-week intervals until symptoms had resolved. Treatment outcome and side-effects were assessed after each treatment session and one month after the last treatment by proctological examination and a questionnaire, including a pain score (visual analogue scale from 0 to 10). Recurrence of complaints was assessed by telephone questionnaire [mean follow-up of 19.2 months (SD 7.8)].

RESULTS: Treatment outcome was assessed in 124 patients (60 RBL, 64 IRC). The mean number of treatment sessions was 1.6 (SD 0.9) for both therapies. For RBL, 58 patients (97%), and for IRC, 59 patients (92%) were symptom-free or had satisfactorily improved. Only third-degree haemorrhoids seemed to respond better to RBL (five of five patients symptom-free) than to IRC (two of four patients symptom-free). Pain following treatment was more common and more severe after RBL (VAS 5.5 +/- 3.7) than after IRC (VAS 3.3 +/- 3.3, P= 0.018). The telephone questionnaire was answered by 105 patients. Nine of 50 patients (18%) treated with RBL and 11 of 55 patients (20%, P= 0.81) treated with IRC had experienced symptomatic relapse to pre-treatment levels.

CONCLUSIONS: Infra-red coagulation and rubber band ligation are equally effective in the treatment of haemorrhoids. The rate and severity of pain is higher after rubber band ligation. Infra-red coagulation should be the first-line treatment for haemorrhoids.

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