Morbid ObesityNCT02218957
Extended Pouch Roux-en-Y Gastric Bypass Study
A study testing Extended Pouch RYGB and Standard RYGB in people with Morbid Obesity, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. 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?
- Extended Pouch RYGB and Standard RYGB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2014to Jul 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient eligible for bariatric surgery according Fried guidelines
- Primary Gastric bypass
- BMI 35 - 40 with a comorbidity
- or BMI > 40
Who cannot join
- Exclusion criteria for bariatric surgery (Fried Guidelines)
- Patients with language problems that interveins to follow medical advises
- Genetic diseases that intervens to follow medical advises
- Chronic bowel diseases
- Nephrologic (MDRD <30) of liver diseases (AST/ALT more than twice the norm)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial
Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.
The objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch results in more weight reduction.
The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.
- Conditions
- Morbid Obesity
- Being tested
- Extended Pouch RYGB, Standard RYGB
- Keywords
- Bariatric surgery, Roux-en-Y Gastric Bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Pouch RYGBProcedure or surgery
Standard RYGBProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard RYGB | Active comparator | Standard RYGB Receives: Procedure: Standard RYGB |
| Extended Pouch RYGB | Experimental | Restrictive/extended pouch RYGB Receives: Procedure: Extended Pouch RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight reduction
Excess weight loss (%EWL)
Measured: 2 years
Secondary outcomes (2)
Change in comorbidities
Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:
- comorbidity resolved
- comorbidity improved
- comorbidity unchanged
- comorbidity worsened
This will be done for diabetes mellitus, hypertension, dyslipidemia and OSAS.
Measured: 2 years
Change in comorbidities
Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:
- comorbidity resolved
- comorbidity improved
- comorbidity unchanged
- comorbidity worsened
This will be done for diabetes mellitus, hypertension, dislipidemia and OSAS.
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 posted18 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2018
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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Homan, MD, Principal investigator, Rijnstate Hospital Arnhem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218957
- Sponsor's protocol ID
- ExtPouch
- Status last verified
- Jun 2024
- First submitted
- 13 Aug 2014
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02218957
- Acronym / sponsor ID
- ExtPouch
- Conditions
- Morbid Obesity
- Keywords
- Bariatric surgery, Roux-en-Y Gastric Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 18 Aug 2014 (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.
Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.
The objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch results in more weight reduction.
The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard RYGB | Active comparator | Procedure: Standard RYGBStandard RYGB |
| Extended Pouch RYGB | Experimental | Procedure: Extended Pouch RYGBRestrictive/extended pouch RYGB |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient eligible for bariatric surgery according Fried guidelines
- Primary Gastric bypass
- BMI 35 - 40 with a comorbidity
- or BMI > 40
Key exclusion criteria (6 listed)
- Exclusion criteria for bariatric surgery (Fried Guidelines)
- Patients with language problems that interveins to follow medical advises
- Genetic diseases that intervens to follow medical advises
- Chronic bowel diseases
- Nephrologic (MDRD <30) of liver diseases (AST/ALT more than twice the norm)
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 |
|---|---|---|
| Extended Pouch RYGB | Procedure or surgery | Extended Pouch RYGB |
| Standard RYGB | Procedure or surgery | Standard RYGB |
Primary outcome
Weight reduction
Time frame: 2 years
Excess weight loss (%EWL)
2 secondary outcomes
Change in comorbidities
Time frame: 2 years
Change in comorbidities
Time frame: 2 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 20 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.
Jens Homan, MD principal investigator
Rijnstate Hospital Arnhem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Pouch RYGB and Standard RYGB 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 4 inclusion and 6 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 20 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?
Weight reduction (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 20 Jun 2024.