The aim of this study is to determine the effectiveness of N-sleeve in terms of a reduction of GERD in morbidly obese patients, compared to LRYGB.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to compare GERD improvement after N-Sleeve versus
LRYGB, for morbidly obese patients with GERD undergoing primary metabolic
surgery.
Secondary outcome
- GERD improvement after 5 years;
- Technical failure rate of the procedure;
- To compare HrQoL between the groups;
- To compare weight loss between the groups;
- To compare the cumulative PPI use between the groups;
- To compare complications rates in the first 30 days between the groups;
- To compare long-term complications rates between the groups;
- To compare the length of hospital stay between the groups;
- To compare the duration of primary surgery between the groups;
- To assess the effects of the operations on comorbidity (hypertension,
diabetes mellitus, and dyslipidaemia);
- To compare presence and grade of oesophagitis (grade A-D) and/ or Barrett*s
oesophagus 1 year postoperatively between the groups;
- To analyse cost-effectiveness of N-Sleeve treatment vs. conventional LRYGB.
Background summary
Bariatric surgery is the most effective treatment for long-term weight loss and
reducing comorbidities in morbidly obese patients. Since 2014 laparoscopic
sleeve gastrectomy (LSG) is the most frequently performed procedure in
bariatric surgery worldwide, followed by laparoscopic Roux-en-Y gastric bypass
(LRYGB). Unfortunately, 10-32% of patients develops gastroesophageal reflux
disease (GERD) after a LSG, which negatively impacts the Health-related Quality
of Life (HrQoL). Moreover, GERD can cause Barrett*s oesophagus, which is a risk
factor for the development of oesophageal adenocarcinoma.
Currently, the golden standard surgical technique for morbidly obese patients
with GERD is LRYGB. No alternative treatment is available, even though GERD can
also develop after LRYGB. Moreover, after a LRYGB patients can develop diarrhea
and in a few cases they develop a internial herniation which makes this
procedure less attractive to some patients. For patients with contraindications
or an explicit wish for another operation, an alternative technique has become
available. This technique is a combination of the Nissen fundoplication, and
LSG, the Nissen-Sleeve (N-Sleeve). It seems to be an effective and save
treatment with 70-88% asymptomatic patients and one (4-10%) complication after
one year. Reported complication rates are comparable to standard bariatric
procedures (8% - 17% after one year). However, N-Sleeve has only been studied
in pilot studies and high-quality data comparing N-sleeve with LRYGB are
lacking.
Study objective
The aim of this study is to determine the effectiveness of N-sleeve in terms of
a reduction of GERD in morbidly obese patients, compared to LRYGB.
Study design
A phase-III randomised controlled trial.
Intervention
Patients will be randomised between N-Sleeve and LRYGB.
Study burden and risks
The investigational treatment is the N-Sleeve. One year after surgery, all
patients will undergo a gastroscopy. Potential burden and risk: The procedures
take about 15 minutes, with low risk of complications. We will try to combine
the gastroscopy with the standard out-patient clinic visits, implying that no
extra hospital visit will be required if possible.
Complications of N-sleeve, are comparable to standard bariatric surgery (4-10%
vs. 8-17%, respectively). Moreover, in long-term N-Sleeve seems to improve
GERD. In addition this alternative technique may reduce length of hospital
stay, readmissions, and re-interventions. Therefore we conclude that the risk
and burden for the patients are in proportion to the expected benefits of the
intervention.
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
Morbidly obese, suitable for bariatric surgery according to the international
guidelines (i.e. BMI >40 without coexisting medical problems or BMI > 35 with
one or more severe obesity-related comorbidities, e.g. metabolic disorders,
cardio-respiratory disease, severe joint disease, obesity-related severe
psychological problems, etc.);
GERD symptoms, according to the Montreal definition such as heartburn,
regurgitation and/or chest pain or PPI treatment because of one or more of
these symptoms (20);
Age >=18 year;
Good command of the Dutch or English language to complete the questionnaires;
Written informed consent.
Exclusion criteria
Patients with altered mental status prohibiting the understanding and giving of
informed consent;
Patients with achalasia;
Patients with malignancy or other abnormalities at gastroscopy making bariatric
surgery unsafe;
Patients with a medical history of abdominal surgery;
Super obese (BMI >= 50kg/m2) ;
Crohn*s disease;
Contraindications to receiving general anaesthesia.
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 | NL77783.100.21 |