A recent study has highlighted that Pneumatic dilation with a 35 mm balloon is not superior to sham dilation for the treatment of persistent dysphagia after fundoplication.These findings have been put forth in the British Medical Journal .
Fundoplication surgery is a commonly performed procedure for gastro-esophageal reflux disease or hiatal hernia repair. Up to 10% of patients develop persistent postoperative dysphagia after surgery. Data on the effectiveness of pneumatic dilation for treatment are limited. To date, There is no evidence-based treatment for persistent dysphagia after laparoscopic fundoplication.
So, Researchers undertook a study with the aim to evaluate the effect of pneumatic dilation on persistent dysphagia after laparoscopic fundoplication.
For the study ,Researchers 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.
Data analysis revealed the following facts.
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.
The researchers concluded that Pneumatic dilation with a 35 mm balloon is not superior to sham dilation for the treatment of persistent dysphagia after fundoplication.
For the full article follow the link: http://dx.doi.org/10.1136/gutjnl-2020-322355
Primary source: British Medical Journal