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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50924

Enrollment

Registered

2021-09-15

Start date

2023-03-28

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD heartburn reflux

Interventions

Patients will be randomised between N-Sleeve and LRYGB.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The primary objective is to compare GERD improvement after N-Sleeve versus LRYGB, for morbidly obese patients with GERD undergoing primary metabolic surgery.	—

Secondary

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)