This monocenter randomized controlled trial aims to compare postoperative outcomes of a laparoscopic valvuloplasty with a Toupet fundoplication in patients with GERD with a maximum hiatal hernia of 3cm. In addition, an economic evaluation of the new…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal signs and symptoms
- Gastrointestinal therapeutic procedures
Synonym
Health condition
middenrif
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Success rate, objective (defined as % of patients with normal values of
reflux measured by pH and impedance monitoring)
Secondary outcome
- Success rate, subjective (defined as % of patients with Visick score I or II)
- Dysphagia (% of patients with complaints of functional dysphagia following
the Rome III criteria, duration is determined by absence of complaints and
normalisation of diet)
- Cost-effectiveness (determined using quality of life, duration of surgery,
length of hospital stay, sick leave duration, medication usage, and other
direct and indirect costs measured by iMTA MCQ/PCQ)
Safety
- Mortality rate (defined as in-hospital mortality or out of hospital mortality
within 30 days)
- Complication rate (intra-operative complication rate)
- Conversion rate
- Disease related reoperation rate (% patients requiring redo surgery for
persisting complaints or* recurrence)
Background summary
Gastroesophageal reflux disease (GERD) is a common chronic disease in western
countries, associated with frequent general practitioner consultations and high
health-care cost.
In 2010, a total of 2.58 million people (15.5% of the total population) used
acid suppression medication. The number of chronic users, defined as 3 or more
prescriptions a year and/or 180 days a year, is almost 7% of the population.
When attempts are made to reduce the dosage or stop the medication entirely,
these efforts are successful in only 30%. The remainder of patients has an
immediate recurrence of symptoms. This results to 800 000 patients with chronic
PPI use.
An alternative to pharmacological treatment is antireflux surgery. Laparoscopic
Toupet fundoplication is currently the golden standard for antireflux surgery,
resulting in relieve of symptoms in 88%-95% of patients, both in short- and
long-term studies.
When the cost-effectiveness of pharmacological treatment is compared to
laparoscopic antireflux surgery, surgery is more expensive initially, but is
the most cost-effective solution long-term after a break-even point at 8 years.
Also patients that undergo surgery for their acid reflux consistently report a
higher quality of life than those with just pharmacological treatment.
Considering the increasing evidence of superiority of surgical management of
pharmacological treatment, the need arises to determine which surgical
procedure is the most beneficial to patients with regards of acid control,
duration of hospital stay, speed of recovery, quality of life and
cost-effectiveness.
The new gastroesophageal valvuloplasty is a laparoscopic technique with equal
if not better surgical and recovery-related results, with prospected lower
per-procedure and indirect costs.
Study objective
This monocenter randomized controlled trial aims to compare postoperative
outcomes of a laparoscopic valvuloplasty with a Toupet fundoplication in
patients with GERD with a maximum hiatal hernia of 3cm. In addition, an
economic evaluation of the new intervention will be done in order to determine
cost-effectiveness and costs per quality-adjusted life-year (QALY).
Study design
Prospective, interventional, double-blinded (patient and researcher),
monocenter randomized controlled trial comparing a laparoscopic
gastroesophageal valvuloplasty to laparoscopic Toupet fundoplication.
Intervention
Laparoscopic gastroesophageal valvuloplasty: Via laparoscopy, using three
sutures a part of the esophagus is folded (similar to the way parts of a
telescope slide in each other) into the stomach, creating a valve on the inside
to prevent gastric acid to enter the esophagus.
Study burden and risks
The valvuloplasty is a technique that only slightly differs in the way the
stomach is handled compared to regular fundoplication. The main benefit of
valvuloplasty is that there is no longer any need to dissect all the blood
vessels on the left side of the stomach. The ligament connecting to the spleen
also remains in place.
When omitting the dissection of the short gastric vessels, a disposable sealing
device (e.g. Ligasure or Harmonic scalpel) costing ¤500,- is no longer
required. The reduction of dissection also results in fewer complications, less
postoperative dysphagia and shorter hospital stay, possibly daycare.
Follow-up by the surgeon will proceed as needed, unchanged by trial
participation. Further trial follow-up will take place by using questionnaires
which take a maximum of 30 minutes to fill in. No additional physical and
physiological discomfort is expected to be associated with trial participation.
Maatweg 3
Amersfoort 3813 TZ
NL
Maatweg 3
Amersfoort 3813 TZ
NL
Listed location countries
Age
Inclusion criteria
Adults with objectively proven gastroesophageal reflux disease and a maximum hiatal hernia of 3cm who are eligible for antireflux surgery.
Exclusion criteria
High BMI (>=30), large hiatal hernia (>=3cm), achalasia, previous upper-GI surgery or inability to understand the Dutch language or fill in the questionnaires.
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 | NL52398.100.15 |