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

Recruiting

• Conditions: GERD, morbidly obese

• Registration Number: NL-OMON27603
• Lead Sponsor: -

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 88

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GERD improvement at one year

Secondary Outcome Measures

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