GASTROESOPAHGEAL REFLUX DISEASE AFTER N-SLEEVE VERSUS ROUX-EN-Y GASTRIC BYPASS (GINSBY): A RANDOMISED CONTROLLED TRIA

Recruiting

Conditions: GERD
heartburn
10003018
10017998
reflux
10017969

Registration Number: NL-OMON50924

Lead Sponsor: Franciscus Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 88

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to compare GERD improvement after N-Sleeve versus<br /><br>LRYGB, for morbidly obese patients with GERD undergoing primary metabolic<br /><br>surgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- GERD improvement after 5 years;<br /><br>- Technical failure rate of the procedure;<br /><br>- To compare HrQoL between the groups;<br /><br>- To compare weight loss between the groups;<br /><br>- To compare the cumulative PPI use between the groups;<br /><br>- To compare complications rates in the first 30 days between the groups;<br /><br>- To compare long-term complications rates between the groups;<br /><br>- To compare the length of hospital stay between the groups;<br /><br>- To compare the duration of primary surgery between the groups;<br /><br>- To assess the effects of the operations on comorbidity (hypertension,<br /><br>diabetes mellitus, and dyslipidaemia);<br /><br>- To compare presence and grade of oesophagitis (grade A-D) and/ or Barrett*s<br /><br>oesophagus 1 year postoperatively between the groups;<br /><br>- To analyse cost-effectiveness of N-Sleeve treatment vs. conventional LRYGB.</p><br>