Morbid ObesityEleganceNCT01686997
Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities
A study testing Roux-en-Y Gastric Bypass 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?
- Roux-en-Y Gastric Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2012to Apr 2016
- 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
- Redo- operation
- medical history: gastric sleeve/ mason / gastric band
- all BMI levels
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: 'Effect of Long biLiopancrEatic Limb lenGth in lAparoscopic Roux-eN-Y Gastric Bypass on Weight Loss and Comorbidities in Patients With Morbid obEsity: 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 variations in the length of biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that longer biliopancreatic limb 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 (short biliopancreatic limb) and long biliopancreatic limb RYGB.
- Conditions
- Morbid Obesity
- Being tested
- Roux-en-Y Gastric Bypass
- 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.
Roux-en-Y Gastric BypassProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Primairy long biliopancreatic limb RYGB | Active comparator | Roux limb 75 cm and Biliopancreatic Limb 150 cm Receives: Procedure: Roux-en-Y Gastric Bypass |
| Redo Long biliopancreatic limb RYGB | Active comparator | Roux limb 75 cm and Biliopancreatic limb 150 cm Receives: Procedure: Roux-en-Y Gastric Bypass |
| Primairy standard RYGB | Active comparator | Roux limb 150 cm and Biliopancreatic limb 75 cm Receives: Procedure: Roux-en-Y Gastric Bypass |
| Redo standard RYGB | Active comparator | Roux limb 150 cm and Biliopancreatic limb 75 cm Receives: Procedure: Roux-en-Y Gastric Bypass |
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 (3)
Decrease in comorbidities
diabetes mellitus, hypertension, hypercholesterolemia, arthrosis
Measured: 2 years
Quality of life
SF-36 and BAROS
Measured: 2 years
Complications and re-operations
bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies
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 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- F.J. Berends, MD, PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686997
- Sponsor's protocol ID
- Elegance01
- Acronym
- Elegance
- Status last verified
- Jun 2016
- First submitted
- 13 Sep 2012
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Homan J, Boerboom A, Aarts E, Dogan K, van Laarhoven C, Janssen I, Berends F. A Longer Biliopancreatic Limb in Roux-en-Y Gastric Bypass Improves Weight Loss in the First Years After Surgery: Results of a Randomized Controlled Trial. Obes Surg. 2018 Dec;28(12):3744-3755. doi: 10.1007/s11695-018-3421-7.
PubMed 30073496
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Effect of Long biLiopancrEatic Limb lenGth in lAparoscopic Roux-eN-Y Gastric Bypass on Weight Loss and Comorbidities in Patients With Morbid obEsity: a Prospective Randomized Control Trial'
- ClinicalTrials.gov ID
- NCT01686997
- Acronym / sponsor ID
- Elegance / Elegance01
- Conditions
- Morbid Obesity
- Keywords
- Bariatric surgery, Roux-en-Y Gastric Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Sep 2012 (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 variations in the length of biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that longer biliopancreatic limb 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 (short biliopancreatic limb) and long biliopancreatic limb RYGB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primairy long biliopancreatic limb RYGB | Active comparator | Procedure: Roux-en-Y Gastric BypassRoux limb 75 cm and Biliopancreatic Limb 150 cm |
| Redo Long biliopancreatic limb RYGB | Active comparator | Procedure: Roux-en-Y Gastric BypassRoux limb 75 cm and Biliopancreatic limb 150 cm |
| Primairy standard RYGB | Active comparator | Procedure: Roux-en-Y Gastric BypassRoux limb 150 cm and Biliopancreatic limb 75 cm |
| Redo standard RYGB | Active comparator | Procedure: Roux-en-Y Gastric BypassRoux limb 150 cm and Biliopancreatic limb 75 cm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient eligible for bariatric surgery according Fried guidelines
- Primary Gastric bypass
- BMI 35 - 40 with a comorbidity
- or BMI > 40
- Redo- operation
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 |
|---|---|---|
| Roux-en-Y Gastric Bypass | Procedure or surgery | Primairy long biliopancreatic limb RYGB, Primairy standard RYGB, Redo Long biliopancreatic limb RYGB, Redo standard RYGB |
Primary outcome
Weight reduction
Time frame: 2 years
excess weight loss (%EWL)
3 secondary outcomes
Decrease in comorbidities
Time frame: 2 years
Quality of life
Time frame: 2 years
Complications and re-operations
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 3 Jun 2016.
- Derived from this study: PubMed 30073496Homan J, Boerboom A, Aarts E, Dogan K, van Laarhoven C, Janssen I, Berends F. A Longer Biliopancreatic Limb in Roux-en-Y Gastric Bypass Improves Weight Loss in the First Years After Surgery: Results of a Randomized Controlled Trial. Obes Surg. 2018 Dec;28(12):3744-3755. doi: 10.1007/s11695-018-3421-7.
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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.
F.J. Berends, MD, PhD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y Gastric Bypass 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 7 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 3 Jun 2016. 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?
On the ClinicalTrials.gov record for NCT01686997, which also lists 1 linked publication.
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 3 Jun 2016.