Effect of pneumodilatation in patients with prolonged dysphagia after antireflux surgery

The most effective treatment for refractory gastro-esophageal reflux disease
(GERD) is laparoscopic fundoplication, in which the fundus of the stomach is
totally (Nissen fundoplication) or partially (Toupet fundoplication) placed
around the distal part of the esophagus. Postoperative dysphagia, a common
side-effect after these operations, is usually self-limiting and generally
disappears after 2-6 weeks. In 5-10% of patients however, prolonged dysphagia
is seen, defined as lasting more than three months postoperatively. There is no
evidence-based treatment for prolonged dysphagia after antireflux surgery, but
the options are an expectative approach or dilation of the lower esophageal
sphincter (LES) and surgically constructed wrap around it with a balloon
(pneumodilatation) or bougie (Savary dilatation). Pneumodilation is generally
believed to be the most effective dilatation technique, but it has never been
shown that dilation of the LES and wrap is actually more effective than the
expectative approach.

To evaluate the effect of pneumodilatation (PD) on prolonged dysphagia after
Toupet or Nissen fundoplication compared to sham dilatation.

A prospective, multicentre, single-blind, randomized, sham-controlled
intervention study.

One group receives a pneumatic dilation (once), and one group receives a
sham-dilation (endoscopy without intervention).

In this study, we evaluate the hypothesis that treatment of patients with
prolonged dysphagia after fundoplication by balloon dilatation is more
effective than sham dilatation. Benefits of treatment are potential dysphagia
relief by a minimally invasive procedure in an outpatient setting, with minimal
pain and only a minimal chance to develop GERD. It has been described that
pneumatic dilation has a positive effect on postoperative dysphagia. However,
it has never been compared to sham dilatation. As it is currently not known
whether balloon dilatation is indeed beneficial, the benefit of the study
participation is uncertain. Risks of participation could be bleeding or
perforation, if pneumodilatation is performed. These risks however, also occur
when it is decided to perform pneumatic dilatation as regular treatment. In
case of complications, the gastroenterologist will decide to re-intervene
endoscopically. The risk of sham dilatation is continuing dysphagia and
concomitant weight loss and pain. The burden of participating patients will be
one extra phone call and filling out questionnaires three times. Moreover, for
the patients of the sham-group, an endoscopy will be performed, while normally
no intervention would be performed in this group of patients given that they
receive no treatment. No extra visits or investigations are necessary, for all
other investigations (HRM, barium esophagogram) are part of the normal work-up
for these patients.