Jan Persson1, Erik Johnsson, Srdjan Kostic, Lars Lundell, Ulrika Smedh. 1. Department of Surgery, Institute of Clinical Sciences, Sahlgrenska University Hospital, Sahlgrenska Academy at the University of Gothenburg, 41345, Gothenburg, Sweden, jan.persson@vgregion.se.
Abstract
BACKGROUND: This study compares the long-term results of pneumatic dilatations versus laparoscopic myotomy using treatment failure as the primary outcome. The frequency and degree of dysphagia, the effects on quality of life (QoL), and health economy were also examined. METHODS:Fifty-three patients with achalasia were randomized to laparoscopic myotomy with a posterior partial fundoplication [laparoscopic myotomy (LM) n = 25] or repetitive pneumatic dilatation [pneumatic dilatation (PD) n = 28]. The median observation period was 81.5 months (range 12-131). RESULTS: At the minimal follow-up of 5 years, ten patients (36%) in the dilatation group and two patients (8%) in the myotomy group, including two patients lost to follow-up (one in each arm), were classified as failures (p = 0.016). The cumulative incidence of treatment failures was analyzed by survival statistics. Taking the entire follow-up period into account, a significant difference was observed in favor of the LM strategy (p = 0.02). Although both treatments resulted in significant improvements in dysphagia scores, LM was significantly favored over PD after 1 and 3 years, but not after 5 years. Health-related QoL assessed by the personal general well being score was higher in the LM group after 3 years, but the difference was not fully statistically significant at 5 years. Direct medical costs during the entire follow-up period were in median $13,421 for LM as compared to $5,558 for PD (p = 0.001). CONCLUSIONS: This long-term follow-up of a randomized clinical study shows that LM is superior to repetitive PD treatment of newly diagnosed achalasia, albeit that this surgical strategy is burdened by high initial direct medical costs. www.ClinicalTrials.gov NCT 02086669.
RCT Entities:
BACKGROUND: This study compares the long-term results of pneumatic dilatations versus laparoscopic myotomy using treatment failure as the primary outcome. The frequency and degree of dysphagia, the effects on quality of life (QoL), and health economy were also examined. METHODS: Fifty-three patients with achalasia were randomized to laparoscopic myotomy with a posterior partial fundoplication [laparoscopic myotomy (LM) n = 25] or repetitive pneumatic dilatation [pneumatic dilatation (PD) n = 28]. The median observation period was 81.5 months (range 12-131). RESULTS: At the minimal follow-up of 5 years, ten patients (36%) in the dilatation group and two patients (8%) in the myotomy group, including two patients lost to follow-up (one in each arm), were classified as failures (p = 0.016). The cumulative incidence of treatment failures was analyzed by survival statistics. Taking the entire follow-up period into account, a significant difference was observed in favor of the LM strategy (p = 0.02). Although both treatments resulted in significant improvements in dysphagia scores, LM was significantly favored over PD after 1 and 3 years, but not after 5 years. Health-related QoL assessed by the personal general well being score was higher in the LM group after 3 years, but the difference was not fully statistically significant at 5 years. Direct medical costs during the entire follow-up period were in median $13,421 for LM as compared to $5,558 for PD (p = 0.001). CONCLUSIONS: This long-term follow-up of a randomized clinical study shows that LM is superior to repetitive PD treatment of newly diagnosed achalasia, albeit that this surgical strategy is burdened by high initial direct medical costs. www.ClinicalTrials.gov NCT 02086669.
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