Morbid ObesityUPGRADENCT05357807
Extending and Banding the Roux-en-Y Gastric Bypass
A study testing Standard RYGB, Extended Pouch RYGB and Banded extended pouch RYGB in people with Morbid Obesity, run by Rijnstate Hospital at 3 sites in Netherlands.
Trial summary
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Standard RYGB, Extended Pouch RYGB and Banded extended pouch RYGB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Mar 2021to 1 Mar 2028
- 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
- All patients who are eligible for a primary RYGB
Who cannot join
- Bariatric surgery in medical history
- Patients with a language barrier which may affect the compliance with 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)
- Hepatic dysfunction (liver function twice the normal values)
- Pregnancy during follow-up
- Patients with treatment-resistant reflux symptoms.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Rijnstate Hospital
Arnhem, Gelderland, 6815AD
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435CM
NOK West
The Hague
About this study
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.
Read the detailed description
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.
A prospective randomize controlled trial.
Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI > 40 kg/m2 without any comorbidities.
Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.
- Conditions
- Morbid Obesity
- Being tested
- Standard RYGB, Extended Pouch RYGB, Banded extended pouch RYGB
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard RYGBProcedure or surgery
Also called S-RYGB
Roux-en-Y Gastric bypass
Extended Pouch RYGBProcedure or surgery
Also called EP-RYGB
Roux-en-Y gastric bypass with an extended pouch
Banded extended pouch RYGBProcedure or surgery
Also called BEP-RYGB
Roux-en-Y gastric bypass with a banded extended pouch
| Study group | Role | What they receive |
|---|---|---|
| Standard RYGB | Active comparator | 127 patients undergo a standard Roux-en-Y gastric bypass Receives: Procedure: Standard RYGB |
| Extended Pouch RYGB | Experimental | 127 patients undergo a Roux-en-Y gastric bypass with an extended pouch. Receives: Procedure: Extended Pouch RYGB |
| Banded Extended RYGB | Experimental | 127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch. Receives: Procedure: Banded extended pouch RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Total Body Weight Loss (%TBWL)
((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
Measured: 3 years
Secondary outcomes (6)
Percentage Excess Weight Loss (%EWL)
((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%. Weight loss measured in kilograms
Measured: 3 years
BODY-Q: Quality of life after bariatric surgery
BODY-Q: Patient reporterd outcome measurement, The questionnaire measures three domains; health related quality of life, appearance and experience of healthcare. Each domain is composed of independently functioning scales. Each scale contains different statements, which can be scored on four levels ranging from totally disagree to totally agree or from never to always. The sum of levels ranging from 1 to 4 is the raw score of the different scales. This score can be converted into a Rasch Transformed score ranging from 0, worst score, to 100, best score.
Measured: 3 years
BAROS: Quality of life after bariatric surgery
BAROS; evaluates the results of obesity treatments by analyzing 3 domains: weight loss, changes in co-morbidities, and quality of life. Up to 3 points are allowed for each, and points are deducted for complications and reoperations. The final score classifies the results in 5 outcome groups, providing an objective definition of success or failure.
Measured: 3 years
SF-36: Quality of life after bariatric surgery
SF-36; consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Measured: 3 years
Gastroesophageal reflux disease
GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.
Measured: 3 years
Change in comorbidities in patients pre- and postoperative
Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA
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 posted3 May 2022
- Study start1 Mar 2021
- Primary completion1 Jun 2023
- Study completion1 Mar 2028 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 375 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
- NCT05357807
- Sponsor's protocol ID
- NL62168.091.17
- Acronym
- UPGRADE
- Status last verified
- Jun 2024
- First submitted
- 25 May 2021
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Extending and Banding the Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT05357807
- Acronym / sponsor ID
- UPGRADE / NL62168.091.17
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 3 May 2022 (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 Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.
Detailed description
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.
A prospective randomize controlled trial.
Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI > 40 kg/m2 without any comorbidities.
Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard RYGB | Active comparator | Procedure: Standard RYGB127 patients undergo a standard Roux-en-Y gastric bypass |
| Extended Pouch RYGB | Experimental | Procedure: Extended Pouch RYGB127 patients undergo a Roux-en-Y gastric bypass with an extended pouch. |
| Banded Extended RYGB | Experimental | Procedure: Banded extended pouch RYGB127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are eligible for a primary RYGB
Key exclusion criteria (8 listed)
- Bariatric surgery in medical history
- Patients with a language barrier which may affect the compliance with 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)
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 |
|---|---|---|
| Standard RYGBAlso: S-RYGBRoux-en-Y Gastric bypass | Procedure or surgery | Standard RYGB |
| Extended Pouch RYGBAlso: EP-RYGBRoux-en-Y gastric bypass with an extended pouch | Procedure or surgery | Extended Pouch RYGB |
| Banded extended pouch RYGBAlso: BEP-RYGBRoux-en-Y gastric bypass with a banded extended pouch | Procedure or surgery | Banded Extended RYGB |
Primary outcome
Percentage Total Body Weight Loss (%TBWL)
Time frame: 3 years
((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
6 secondary outcomes
Percentage Excess Weight Loss (%EWL)
Time frame: 3 years
BODY-Q: Quality of life after bariatric surgery
Time frame: 3 years
BAROS: Quality of life after bariatric surgery
Time frame: 3 years
SF-36: Quality of life after bariatric surgery
Time frame: 3 years
Gastroesophageal reflux disease
Time frame: 3 years
Change in comorbidities in patients pre- and postoperative
Time frame: 3 years
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 21 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard RYGB, Extended Pouch RYGB and Banded extended pouch RYGB in people with Morbid Obesity, run by Rijnstate Hospital at 3 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 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: under way, not looking for participants, 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 3 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?
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.