TY - JOUR
T1 - Pneumatic dilation for persistent dysphagia after antireflux surgery, a multicentre single-blind randomised sham-controlled clinical trial
AU - Schuitenmaker, Jeroen M.
AU - van Hoeij, Froukje B.
AU - Schijven, Marlies P.
AU - Tack, Jan
AU - Conchillo, José M.
AU - Hazebroek, Eric J.
AU - Smout, André J. P. M.
AU - Bredenoord, Albert J.
N1 - Funding Information: 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. Publisher Copyright: ©
PY - 2022/1/1
Y1 - 2022/1/1
N2 - 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.
AB - 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.
KW - anti-reflux surgery
KW - dysphagia
KW - gastro-esophageal reflux disease
KW - lower oesophageal sphincter
UR - http://www.scopus.com/inward/record.url?scp=85099542451&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/gutjnl-2020-322355
DO - https://doi.org/10.1136/gutjnl-2020-322355
M3 - Article
C2 - 33452179
VL - 71
SP - 10
EP - 15
JO - Gut
JF - Gut
SN - 0017-5749
IS - 1
ER -