K Becker1, S Biesenbach, J F Erckenbrecht, T Frieling. 1. Department of Internal Medicine, Hospital "Florence Nightingale", Kaiserswerther Diakonie, Düsseldorf, Germany. becker@kaiserswerther-diakonie.de
Abstract
BACKGROUND:Pneumatic dilation is the standard non-surgical treatment of achalasia. The dilation devices in use differ in their physical properties, particularly with regard to balloon compliance. PATIENTS AND METHODS: 35 achalasia patients (18male, 20-82 years, median 45 years) diagnosed by accepted criteria were prospectively and randomly assigned to 39 dilation procedures by either a low compliance dilation device (LCDD, polyethylene balloon, Rigiflex(trade mark), Microvasive Boston Scientific, USA, n = 18) or a high compliance dilation device (HCDD, latex balloon, Rüsch Inc., Germany, n = 17). Individual complaints were graded by a standardized questionnaire before treatment and prospectively after a median of 3 and 13 months. Furthermore, the patients' readiness to retrospectively re-consent (treatment satisfaction) and treatment complications were recorded. RESULTS: Patient groups did not differ with regard to age, sex, number of previous dilations, and duration of follow-up (Mann-Whitney U-test, p > 0.05). 2 patients were excluded from follow-up, with one individual (HCDD) having suffered a dilation-related perforation (2.6 %) and another subject (LCDD) having not been able to re-contact. Initial and post-treatment symptom scores as well as treatment complications were similar in both treatment groups (p > 0.05). Treatment satisfaction was 90 % for the LCDD and 82 % for the HCDD group at first control, and 89 % and 87 % at second control, respectively (p > 0.05). In both patient groups, dilation therapy best improved the symptom "dysphagia" (Wilcoxon rank sum test, p < 0.05). CONCLUSIONS:Achalasia patients' satisfaction of dilation treatment is high, with their dysphagia benefiting most from therapy. Low and high compliance balloon devices did not differ from each other with regard to symptomatic efficacy and safety in forceful dilation of these individuals.
RCT Entities:
BACKGROUND: Pneumatic dilation is the standard non-surgical treatment of achalasia. The dilation devices in use differ in their physical properties, particularly with regard to balloon compliance. PATIENTS AND METHODS: 35 achalasiapatients (18male, 20-82 years, median 45 years) diagnosed by accepted criteria were prospectively and randomly assigned to 39 dilation procedures by either a low compliance dilation device (LCDD, polyethylene balloon, Rigiflex(trade mark), Microvasive Boston Scientific, USA, n = 18) or a high compliance dilation device (HCDD, latex balloon, Rüsch Inc., Germany, n = 17). Individual complaints were graded by a standardized questionnaire before treatment and prospectively after a median of 3 and 13 months. Furthermore, the patients' readiness to retrospectively re-consent (treatment satisfaction) and treatment complications were recorded. RESULTS:Patient groups did not differ with regard to age, sex, number of previous dilations, and duration of follow-up (Mann-Whitney U-test, p > 0.05). 2 patients were excluded from follow-up, with one individual (HCDD) having suffered a dilation-related perforation (2.6 %) and another subject (LCDD) having not been able to re-contact. Initial and post-treatment symptom scores as well as treatment complications were similar in both treatment groups (p > 0.05). Treatment satisfaction was 90 % for the LCDD and 82 % for the HCDD group at first control, and 89 % and 87 % at second control, respectively (p > 0.05). In both patient groups, dilation therapy best improved the symptom "dysphagia" (Wilcoxon rank sum test, p < 0.05). CONCLUSIONS:Achalasiapatients' satisfaction of dilation treatment is high, with their dysphagia benefiting most from therapy. Low and high compliance balloon devices did not differ from each other with regard to symptomatic efficacy and safety in forceful dilation of these individuals.