To compare the outcome of endoluminal fundoplication with Esophyx* to laparoscopic Nissen fundoplication for GERD in selected patient population.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of patients with objective normalization of acid exposure, without
suffering form severe dysphagia at 6 months.
Secondary outcome
Percentage of patients free from PPI*s
Quality of Life (QoL) and GERD related QoL (GERD-HRQoL) and esophageal symptoms
(OES18-score)
Percentage of patients with resolved, improved, unchanged and worsened symptoms
(Visick grade)
Prevalence of esophagitis
Pressure of the Lower Esophageal Sphincter
Percentage acidic, weakly acidic and gas reflux
Total costs
Background summary
GERD refractory to acid suppression, with a documented relation between
symptoms and reflux episodes, is a well accepted indication for antireflux
surgery. Laparoscopic Nissen fundoplication is the current golden standard for
the invasive therapy for GERD. Endoluminal fundoplication (EsophyX*) may be is
an endoscopic alternative for this procedure. In selected patients, this
procedure has potential benefits. The technique does not require opening of the
abdominal cavity, minimizing chances of complications like intra-abdominal
damage. The new treatment reduces invasiveness, when compared to laparoscopic
Nissen fundoplication. This results in less post-operative pain, less
morbidity, better cosmesis and shorter hospitalization. Moreover, sick leave
from paid work is shorter after the EsophyX* procedure. These advantages will
reduce total costs compared to the conventional procedure. The outcome of
endoluminal fundoplication has not yet been compared to the outcome of
laparoscopic Nissen fundoplication. This needs to be evaluated to make the
right therapeutic decisions for future GERD patients.
Study objective
To compare the outcome of endoluminal fundoplication with Esophyx* to
laparoscopic Nissen fundoplication for GERD in selected patient population.
Study design
Randomized, blinded clinical multicentre trial
Intervention
After randomization, eighty patients will undergo endoluminal EsophyX*
fundoplication en will be compared to eighty patients who will undergo
laparoscopic Nissen fundoplication
Study burden and risks
Similar to all patients that may have an indication for antireflux surgery, the
patients that participate will undergo a preoperative upper endoscopy, short
manometry and 24-hr pH-impedance study. Patients will be asked to fill out
questionnaires before surgery (15 min), both on acid suppressing drugs and
after stopping acid suppressing drugs in preparation of the preoperative
investigations. These questionnaires will register general quality of life,
GERD related QoL and esophageal symptoms. Patients will register medication use
in a diary up to thirty days after surgery. One month after surgery, patients
will be asked to fill out a short questionnaire (5 min) to register esophageal
symptoms. Three, six and twelve months after the operation, the participants
will be asked to fill out the questionnaires on general quality of life, GERD
related QoL and esophageal symptoms (15 min). These questionnaires are as short
as possible tot reduce the burden for the patients.
Six months after surgery upper endoscopy, short manometry and 24-hr
pH-impedance study will be repeated. 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, objective follow-up is essential to
compare the outcome of the new procedure to the current golden standard. This
will result in better therapy choices for future patients. 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.
Postbus 85500 Huispost G04.228
3508 GA Utrecht
NL
Postbus 85500 Huispost G04.228
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
- Perseverance of reflux related complaints for over 6 months despite of double dose PPI use ( >= 40 mg omeprazole / 24 hours or comparable therapy) and/or refusal of taking lifelong antireflux medication.
- Patients without a diaphragmatic hernia or a sliding hernia of max. 2 cm (endoscopically measured distance from Z-line and impression of the diaphragm).
- Pathological ambulatory 24 hour pH test (upright acid exposure > 8.4%, supine acid exposure > 3.4 % and/or total acid exposure > 5.8% and symptom association probability (SAP) > 95%)
- Age: 18-65 years
- Healthy patients with no disease outside of the surgical process and patients with mild to moderate systemic disease caused by the surgical condition or by other pathological processes, medically well-controlled (American Society of Anaesthesiologists classification of preoperative risk 1 or 2)
Exclusion criteria
- Patients with a diaphragmatic hernia other than of the sliding type and / or larger than 2 cm (endoscopically measured).
- Grade C and D esophagitis (Los Angeles classification).
- Histologically proven long-segment Barrett*s esophagus (>2 cm).
- Patients with severe objectified esophageal or gastric motility disorder.
- Patients with a history of esophageal- or gastric surgery.
- Patients with contraindications for undergoing a laparoscopic Nissen fundoplication or endoluminal fundoplication with Esophyx*, for example esophageal stenosis, esophageal stricture, portal hypertension, esophageal varices or diverticulae, active gastro-duodenal ulcer, previous Enteryx, Gatekeeper or Stretta treatment.
- Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the objective follow up tests.
- Pregnant women.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17954.041.07 |