Bariatric Surgery CandidateRoux-en-WHY?NCT04852198
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
A study testing OAGB and RYGB in people with Bariatric Surgery Candidate and Obesity, run by Flevoziekenhuis at 2 sites in Netherlands.
Trial summary
The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity, Obesity, Morbid
- What is being tested?
- OAGB and RYGB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 2 sitesNetherlands
- Study dates
- 13 Dec 2021to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of H. Pylori, resistant to eradication therapy
- chronic diarrhoea
- history of previous bariatric or extensive abdominal surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Flevoziekenhuis
Almere Stad, 1315RA
Floris Bruinsma, MD, florisbruinsma@live.nl
Christel Boons, PhD, wetenschapsbureau@flevoziekenhuis.nl
- Not yet recruiting
OLVG
Amsterdam, 1061AE
Phillip Dijkhorst, MD, p.j.dijkhorst@olvg.nl
Robin Debi, r.a.debi@olvg.nl
About this study
Official title: A Study on Safety and Efficacy Comparing 150cm One Anastomosis Gastric Bypass With 150cm Biliopancreatic Limb Roux-en-Y Gastric Bypass (Roux-en-WHY?): An Open Label, Multicentre Non-inferiority Randomized Controlled Trial
The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB
Read the detailed 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)
- Conditions
- Bariatric Surgery Candidate, Obesity, Obesity, Morbid
- Being tested
- OAGB, RYGB
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OAGBProcedure or surgery
Also called Mini gastric bypass, Omega loop gastric bypass
Simplified gastric bypass procedure
RYGBProcedure or surgery
Roux-en-Y gastric bypass. Standard procedure in the Netherlands
| Study group | Role | What they receive |
|---|---|---|
| OAGB | Active comparator | 149 patients receiving one anastomosis gastric bypass (OAGB) with a Biliopancreatic-limb of 150cm Receives: Procedure: OAGB |
| RYGB | Active comparator | 149 patients receiving Roux-en-Y gastric bypass (RYGB) with a Biliopancreatic-limb of 150cm Receives: Procedure: RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage excess BMI loss at 2 years (%EBMIL)
Percentage excess BMI loss after 2 years of follow-up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start13 Dec 2021
- Primary completion13 Jun 2027 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with 2 groups
- Masking
- None (open label)
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flevoziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stef JM Smeets, MD PhD, Principal investigator, Flevoziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852198
- Sponsor's protocol ID
- FZ 20/22
- Other IDs
- NL74137.018.20
- Acronym
- Roux-en-WHY?
- Status last verified
- Apr 2024
- First submitted
- 6 Oct 2020
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Safety and Efficacy Comparing 150cm One Anastomosis Gastric Bypass With 150cm Biliopancreatic Limb Roux-en-Y Gastric Bypass (Roux-en-WHY?): An Open Label, Multicentre Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04852198
- Acronym / sponsor ID
- Roux-en-WHY? / FZ 20/22
- Conditions
- Bariatric Surgery Candidate, Obesity, Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- FlevoziekenhuisUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 13 Jun 2027 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB
Detailed 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with 2 groups
| Arm | Type | Receives |
|---|---|---|
| OAGB | Active comparator | Procedure: OAGB149 patients receiving one anastomosis gastric bypass (OAGB) with a Biliopancreatic-limb of 150cm |
| RYGB | Active comparator | Procedure: RYGB149 patients receiving Roux-en-Y gastric bypass (RYGB) with a Biliopancreatic-limb of 150cm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of H. Pylori, resistant to eradication therapy
- chronic diarrhoea
- history of previous bariatric or extensive abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OAGBAlso: Mini gastric bypass, Omega loop gastric bypassSimplified gastric bypass procedure | Procedure or surgery | OAGB |
| RYGBRoux-en-Y gastric bypass. Standard procedure in the Netherlands | Procedure or surgery | RYGB |
Primary outcome
Percentage excess BMI loss at 2 years (%EBMIL)
Time frame: 2 years
Percentage excess BMI loss after 2 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stef JM Smeets, MD PhD principal investigator
Flevoziekenhuis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OAGB and RYGB in people with Bariatric Surgery Candidate and Obesity, run by Flevoziekenhuis at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stef JM Smeets, MD PhD (0031368688888, ssmeets@flevoziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage excess BMI loss at 2 years (%EBMIL) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.