The TOUCAN trial: a randomised, blind, clinical trial that compares the effects of TOUpet fundopliCAtion and Nissen fundoplication on the mechanics of the gastroesophageal junction.

Gastroesophageal reflux disease (GERD) is a chronic disease with a
high-prevalence. GERD refractory to acid suppression, with a documented
relation between symptoms and reflux episodes, is a well accepted indication
for antireflux surgery. Total, or Nissen, fundoplication is the most frequently
performed surgical therapy for medication refractory GERD. This laparoscopic
procedure creates a wrap of the proximal stomach around the distal esophagus
and ensures superior reflux control. The most important complication of this
therapy is the development of persistent esophageal passage disorders
(dysphagia) in a considerable number of patients. An alternative therapy is
partial Toupet fundoplication, a procedure that creates a partial, 270 degree,
wrap of the stomach around the distal esophagus.
Dysphagia occurs less frequently after Toupet fundoplicatie than after Nissen
fundoplication. Despite this, Nissen fundoplication is the most frequently
performed antireflux procedure worldwide, since it is controversial whether
Toupet fundoplication equals reflux control after Nissen fundoplication. These
differences require further research, since there is currently no consensus
about which procedure is the surgical therapy of choice. Dysphagia severely
impairs quality of life and often requires surgical reintervention. Therefore,
it is important to identify differences in the mechanisms leading to dysphagia
after Toupet and Nissen fundoplication. If the results of the current study
will give sufficient insight into the differences in the mechanisms leading to
dysphagia, this could be the starting point of a subsequent study investigating
which modifications of the Nissen fundoplication reduce the incidence of this
important complication.

To identify differences in the mechanisms leading to dysphagia after
laparoscopic Toupet and Nissen fundoplication.

Randomized, blind, clinical multicenter trial

After randomization, twenty-five patients will undergo laparoscopic Toupet
fundoplication and will be compared to twenty-five patients who will undergo
laparoscopic Nissen fundoplication.

Similar to all patients that may have an indication for antireflux surgery, the
patients that participate will undergo a preoperative upper endoscopy, barium
swallow, short manometry and 24-hr pH-impedance study. In addition, a FLIP
investigation will be performed for the purpose of this study. Patients will be
asked to fill out questionnaires before surgery (25 min). These questionnaires
will register dysphagia, quality of life and reflux symptoms. One, three, six
and twelve months after the operation, the participants will be asked to fill
out the questionnaires on general quality of life, GERD symptoms and dysphagia
(25 min). These questionnaires are as short as possible tot reduce the burden
for the patients.

Six months after surgery routine upper endoscopy, barium swallow, short
manometry and 24-hr pH-impedance study will be repeated to evaluate the effect
of fundoplicaton. In addition, a FLIP investigation will be performed for the
purpose of this study. All these investigations are safe and complications are
rare. The department of surgery of the UMC Utrecht has conducted three large
follow-up studies, investigating the subjective and objective results of Nissen
fundoplication in a similar way. This research has demonstrated that the
postoperative complaints reported by patient do not correlate with reflux
episodes. Therefore, routine objective follow-up is essential. The
postoperative investigations will be similar to the previously mentioned
studies. These investigations are a considerable burden for the patients, but
in our experience, patients are willing to undergo these additional tests.