Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial (Roux-en-WHY?)

Flevoziekenhuis

Status: Enrolling

Conditions: Bariatric Surgery Candidate; Obesity; Obesity, Morbid

Treatments: Procedure: RYGB; Procedure: OAGB

Study type: Interventional

Funder types: Other

Identifiers

NCT04852198

NL74137.018.20 (Other Identifier)

FZ 20/22

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB

Full description

Rationale: to compare two different types of gastric bypass operations on surgical outcome.

Objective: to compare two established procedures in order to find the optimal procedure in terms of weight loss and metabolic control that is associated with the fewest side-effects and complications, and decreased invasiveness.

Study design: A multicentre, open label, non-inferiority randomized controlled trial Study population: Patients are eligible for inclusion if their body-mass index (BMI) was 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee) and a positive evaluation by our bariatric multidisciplinary team (BMDT) and are aged 18-65.

Intervention: Group 1: One Anastomosis Gastric Bypass with 150cm biliopancreatic limb. Group 2: Roux-en-Y gastric bypass with biliopancreatic limb of 150cm and 75cm alimentary limb.

Main study parameters/endpoints:

Primary endpoint:

% Excess BMI loss at two years

Secondary endpoints:

Metabolic status Nutritional status Comorbidity remission QOL Complications or serious adverse events (SAE's)

Enrollment: 298 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• body-mass index (BMI) of 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee)
• a positive evaluation by our BMDT

Exclusion criteria

• Presence of H. Pylori, resistant to eradication therapy
• chronic diarrhoea
• history of previous bariatric or extensive abdominal surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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298 participants in 2 patient groups

OAGB

Active Comparator group

Description:

149 patients receiving one anastomosis gastric bypass (OAGB) with a Biliopancreatic-limb of 150cm

Treatment:

Procedure: OAGB

RYGB

Active Comparator group

Description:

149 patients receiving Roux-en-Y gastric bypass (RYGB) with a Biliopancreatic-limb of 150cm

Treatment:

Procedure: RYGB