Study protocol: gastroesopahgeal reflux disease after N-sleeve versus Roux-en-Y gastric bypass (GINSBY): a randomised controlled trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27603

Enrollment

Registered

2021-10-05

Start date

2022-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

GERD, morbidly obese

Interventions

N-Sleeve or Roux-en-Y gastric bypass

Eligibility

Inclusion criteria

Inclusion criteria: Morbidly obese patients older than 18 years with GERD according to the Montreal definition, eligible for bariatric surgery. Good command of the Dutch or English language to complete the questionnaires;

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 (such as low- and high-grade dysplasia) 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
GERD improvement at one year	—

Secondary

Measure	Time frame
- GERD improvement after 5 years between both groups; - 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 between both groups; - 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.

—

Contacts

Public ContactJudith 't Hart

Franciscus Gasthuis & Vlietland

j.hart@franciscus.nl0031104616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)