A study on safety and efficacy comparing 150cm One Anastomosis Gastric Bypass with 150cm BP limb Roux-en-Y Gastric Bypass (Roux-en-WHY?): An open label, multicentre non-inferiority randomized controlled trial

A study on safety and efficacy comparing 150cm One Anastomosis Gastric Bypass with 150cm BP limb Roux-en-Y Gastric Bypass (Roux-en-WHY?): An open label, multicentre non-inferiority randomized controlled trial - Roux-en-WHY?

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54369

Enrollment

298

Registered

2021-05-06

Start date

2021-12-13

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

obesitas Obestity overweight

Interventions

OAGB (compared with normal RYGB treatment, 1:1)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria are BMI >40kg/m2, or BMI >35kg/m2 with at least one of the following comorbidities: type 2 diabetes, hypertension, dyslipidaemia, obstructive sleep apnoea, or osteoarthritis of the hip or knee; age 18-65 years; positive evaluation by a Bariatric multidisciplinary team (BMDT, consisting of psychologists, dietitians, internists and bariatric surgeons); and written informed consent

Exclusion criteria

Exclusion criteria: Exclusion criteria will be presence of Helicobacter pylori resistant to eradication therapy, the presence of chronic diarrhoea, or previous bariatric or extensive abdominal surgery.

Design outcomes

Primary

Measure	Time frame
% excess BMI loss at 2 years	—

Secondary

Measure	Time frame
% Excess BMI loss at 5 years Operation time (measured in minutes, from incision until closure), Diabetes remission (measured in HbA1c%, fasting plasma glucose and the need for anti-diabetic medication will be recorded) Hypertension remission (need for anti-hypertensive medication will be recorded), Post-operative complications (30 days; e.g. bowel obstruction, internal herniation or revision surgery), Dyslipidaemia control (measured by LDL and total cholesterol and the need for lipid-lowering medication will be recorded), Diarrhea (measured using the Bristol Stool Chart, in combination with the stool frequency), Malnutrition (measured by serum albumin), Mineral and vitamin deficiencies (measured by serum calcium, parathyroid hormone, iron, ferritin, transferrin coefficient, iron saturation, folic acid, vitamin B1, B6, B12, vitamin D), Anaemia (measured by haemoglobuline), Pancreatic activity (measured by fecal elastase in the 24h stools)., Dumping syndrome (measured using the Arts Dumping Scale), Gastro-esophageal reflux (measured using the GERD-Q questionnaire)	—

Measure

Time frame

% Excess BMI loss at 5 years Operation time (measured in minutes, from incision until closure), Diabetes remission (measured in HbA1c%, fasting plasma glucose and the need for anti-diabetic medication will be recorded) Hypertension remission (need for anti-hypertensive medication will be recorded), Post-operative complications (30 days; e.g. bowel obstruction, internal herniation or revision surgery), Dyslipidaemia control (measured by LDL and total cholesterol and the need for lipid-lowering medication will be recorded), Diarrhea (measured using the Bristol Stool Chart, in combination with the stool frequency), Malnutrition (measured by serum albumin), Mineral and vitamin deficiencies (measured by serum calcium, parathyroid hormone, iron, ferritin, transferrin coefficient, iron saturation, folic acid, vitamin B1, B6, B12, vitamin D), Anaemia (measured by haemoglobuline), Pancreatic activity (measured by fecal elastase in the 24h stools)., Dumping syndrome (measured using the Arts Dumping Scale), Gastro-esophageal reflux (measured using the GERD-Q questionnaire)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)