Morbid ObesityBandoleraNCT02545647
Banded Versus Non-banded Roux-en-y Gastric Bypass
A study testing BRYGB in people with Morbid Obesity, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- BRYGB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2015to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients who are eligible for a primary RYGB
Who cannot join
- Bariatric surgery in history
- Patients with a language barrier which may affect the compliance with medical advice
- Any kind of genetic disorders which can be of influence on the monitoring of medical advice
- Patients with a disease not related to morbid obesity, such as Cushing or drug related.
- Chronic bowel disease for example Crohn's disease or colitis Colitis.
- Renal impairment (MDRD <30) or hepatic dysfunction (liver function twice the normal values)
- Pregnancy
- Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Banded Versus Non-banded Roux-en-y Gastric Bypass, a Randomised Controlled Trial
A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.
Read the detailed description
A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.
The Study design is a prospective, randomized, single center study.
Study population: patients who qualify for a RYGB are eligible to participate. The primary RYGB patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher.
Intervention: The standard RYGB with a vertical pouch over a 40 french feeding tube with a volume of 30-50 ml, is compared with a banded-RYGB (BRYGB)
- Conditions
- Morbid Obesity
- Being tested
- BRYGB
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRYGBDevice
Also called banded RYGB
65 patients undergo a banded RYGB
| Study group | Role | What they receive |
|---|---|---|
| Standard RYGB | No intervention | 65 patients undergo a standard Roux-en-Y gastric bypass |
| Banded RYGB | Active comparator | 65 patients undergo a banded RYGB (BRYGB) Receives: Device: BRYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage total body weight loss (%TBWL)
weight loss is measured in kilogram.
Measured: 3 years
Secondary outcomes (6)
Percentage excess weight loss (%EWL)
excess weight loss is measured in kilogram.
Measured: 3 years
percentage total body weight regain (%TBWR)
Weight regain is measured in kilogram.
Measured: 3 years
Decrease in type 2 diabetes mellitus
measuring glycated hemoglobin, decrease in diabetic medication
Measured: 3 years
Quality of life
measuring BAROS score
Measured: 3 years
Decrease in dyslipidaemia
decrease in medication for hypercholesterolaemie. Measuring cholesterol spectrum.
Measured: 3 years
Decrease in hypertension
Measuring blood pressure
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2019
- Study completionMay 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545647
- Sponsor's protocol ID
- 2015-0624
- Acronym
- Bandolera
- Status last verified
- Jun 2024
- First submitted
- 3 Sep 2015
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Banded Versus Non-banded Roux-en-y Gastric Bypass, a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02545647
- Acronym / sponsor ID
- Bandolera / 2015-0624
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 10 Sep 2015 (estimated)
- 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.
A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.
Detailed description
A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.
The Study design is a prospective, randomized, single center study.
Study population: patients who qualify for a RYGB are eligible to participate. The primary RYGB patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher.
Intervention: The standard RYGB with a vertical pouch over a 40 french feeding tube with a volume of 30-50 ml, is compared with a banded-RYGB (BRYGB)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard RYGB | No intervention | –65 patients undergo a standard Roux-en-Y gastric bypass |
| Banded RYGB | Active comparator | Device: BRYGB65 patients undergo a banded RYGB (BRYGB) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients who are eligible for a primary RYGB
Key exclusion criteria (8 listed)
- Bariatric surgery in history
- Patients with a language barrier which may affect the compliance with medical advice
- Any kind of genetic disorders which can be of influence on the monitoring of medical advice
- Patients with a disease not related to morbid obesity, such as Cushing or drug related.
- Chronic bowel disease for example Crohn's disease or colitis Colitis.
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 |
|---|---|---|
| BRYGBAlso: banded RYGB65 patients undergo a banded RYGB | Device | Banded RYGB |
Primary outcome
Percentage total body weight loss (%TBWL)
Time frame: 3 years
weight loss is measured in kilogram.
6 secondary outcomes
Percentage excess weight loss (%EWL)
Time frame: 3 years
percentage total body weight regain (%TBWR)
Time frame: 3 years
Decrease in type 2 diabetes mellitus
Time frame: 3 years
Quality of life
Time frame: 3 years
Decrease in dyslipidaemia
Time frame: 3 years
Decrease in hypertension
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRYGB in people with Morbid Obesity, run by Rijnstate Hospital at 1 site 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage total body weight loss (%TBWL) (time frame: 3 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 21 Jun 2024.