Objective There is no evidence-based treatment for persistent dysphagia after laparoscopic fundoplication. The aim of this study was to evaluate the effect of pneumatic dilation on persistent dysphagia after laparoscopic fundoplication.
Design We performed a multicentre, single-blind, randomised sham-controlled trial of patients with persistent dysphagia (>3 months) after laparoscopic fundoplication. Patients with an Eckardt symptom score ≥4 were randomly assigned to pneumatic dilation (PD) using a 35 mm balloon or sham dilation. Primary outcome was treatment success, defined as an Eckardt score <4 and a minimal reduction of 2 points in the Eckardt score after 30 days. Secondary outcomes included change in stasis on timed barium oesophagogram, change in high-resolution manometry parameters and questionnaires on quality of life, reflux and dysphagia symptoms.
Results Forty-two patients were randomised. In the intention-to-treat analysis, the success rates of PD (7/21 patients (33%)) and sham dilation (8/21 patients (38%)) were similar after 30 days (risk difference −4.7% (95% CI (−33.7% to 24.2%) p=0.747). There was no significant difference in change of stasis on the timed barium oesophagogram after 2 min (PD vs sham: median 0.0 cm, p25–p75 range 0.0–4.3 cm vs median 0.0 cm, p25–p75 range 0.0–0.0; p=0.122) or change in lower oesophageal sphincter relaxation pressure (PD vs sham: 10.54±6.25 vs 14.60±6.17 mm Hg; p=0.052). Quality of life, reflux and dysphagia symptoms were not significantly different between the two groups.
Conclusion Pneumatic dilation with a 35 mm balloon is not superior to sham dilation for the treatment of persistent dysphagia after fundoplication.
- gastro-esophageal reflux disease
- anti-reflux surgery
- lower oesophageal sphincter
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JMS and FBvH contributed equally.
Contributors FBvH, MPS, JT, JMC, EJH, AJPMS and AJB—study concept and design. JMS, FBvH, MPS, AJPMS, JT, JMC and AJB—acquisition of data. JMS, FBvH, AJPMS and AJB—analysis and interpretation of data. JMS, FBvH and AJB—drafting of the manuscript. All authors—critical revision of the manuscript for important intellectual content. JMS, FBvH and AJB—statistical analysis. AJB—supervised the project.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests JT received grant support from Sofar, received consulting fees from Ironwood and received speaker fees from Truvion. AJB received grant support from Bayer, Norgine, Nutricia, SST, and received speaker and/or consulting fees from Reckitt Benckiser, Laborie, Medtronic, Regeneron, Celgene, Arena, Esocap, Calypso, AstraZeneca and DrFalk.
Patient consent for publication Not required.
Ethics approval The local Medical Ethics Committee AMC approved the study—Amsterdam 2014-262#B2014893.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplemental information.
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