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| ID | Type | Description | Link |
|---|---|---|---|
| NL74137.018.20 | Other Identifier | CCMO |
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The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OAGB | Active Comparator | 149 patients receiving one anastomosis gastric bypass (OAGB) with a Biliopancreatic-limb of 150cm |
|
| RYGB | Active Comparator | 149 patients receiving Roux-en-Y gastric bypass (RYGB) with a Biliopancreatic-limb of 150cm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OAGB | Procedure | Simplified gastric bypass procedure |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage excess BMI loss at 2 years (%EBMIL) | Percentage excess BMI loss after 2 years of follow-up | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stef JM Smeets, MD PhD | Contact | 0031368688888 | ssmeets@flevoziekenhuis.nl | |
| Floris Bruinsma, Student | Contact | 0031368688888 | fbruinsma@flevoziekenhuis.nl |
| Name | Affiliation | Role |
|---|---|---|
| Stef JM Smeets, MD PhD | Flevoziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flevoziekenhuis | Recruiting | Almere Stad | 1315RA | Netherlands |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized controlled trial with 2 groups
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| RYGB | Procedure | Roux-en-Y gastric bypass. Standard procedure in the Netherlands |
|
| OLVG | Not yet recruiting | Amsterdam | 1061AE | Netherlands |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |