Obesity, MorbidSLIMNCT04219787
Different Limb Lengths in Gastric Bypass Surgery
A study testing Long BPL LRYGB and Short BPL LRYGB in people with Obesity, Morbid and Diabetes Mellitus, Type 2, run by Clarunis - Universitäres Bauchzentrum Basel at 1 site in Switzerland.
Trial summary
Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Long BPL LRYGB and Short BPL LRYGB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2020to 30 Nov 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
- informed consent as documented by signature
- patients with BMI of 35 kg/m2 or higher who comply with the regulatory rules for bariatric surgery in Switzerland
Who cannot join
- general contraindications to kind of surgery
- known or suspected non-compliance, drug or alcohol abuse
- inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant
- participation in another study
- age < 18 years or > 65 years
- BMI > 60 kg/m2
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- height < 145 cm
- CL length of < 180 cm as measured intraoperatively
- ASA physical status classification > III
- inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clarunis University Center for Gastrointestinal and Liver Diseases
Basel
About this study
Official title: Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery
Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients. One of the most frequently performed operations is the laparoscopic proximal Roux-en-Y gastric bypass (LRYGB). There is still lack of knowledge why some patients respond much better than others to an identically performed procedure. Therefore, a number of variations of this operation have been introduced over the past 50 years. Increasing the length of small bowel being bypassed has the potential to improve the effect of the operation but buries the risk of nutrient deficiencies. The metabolic effect of LRYGB occurs, in part, independently of weight loss. The mechanisms underlying metabolic improvement through metabolic surgery are not yet fully understood.
- Being tested
- Long BPL LRYGB, Short BPL LRYGB
- Keywords
- Roux-en-Y Gastric Bypass, Biliopancreatic Limb Length
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long BPL LRYGBProcedure or surgery
Also called LBPL LRYGB
LRYGB with an 180 cm BPL and an AL of 80 cm.
Short BPL LRYGBProcedure or surgery
Also called SBPL LRYGB
The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.
| Study group | Role | What they receive |
|---|---|---|
| Long Biliopancreatic Limb LRYGB | Experimental | LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm. Receives: Procedure: Long BPL LRYGB |
| Short Biliopancreatic Limb LRYGB | Active comparator | Standard LRYGB with a 80 cm BPL and a 180 cm long AL. Receives: Procedure: Short BPL LRYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Percent total weight loss (%TWL, superiority), while not leading to a larger nutritional de- ficiency rate (non-inferiority).
Measured: From baseline to 5 years after surgery.
Secondary outcomes (1)
Secondary endpoints
Percent excess body mass index loss (%EBMIL), remission of comorbidities, complication rate/safety, and quality of life 1, 3, and 5 years after long and short BPL RYGB.
Measured: From baseline to 5 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Jun 2020
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
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 Obesity, MorbidStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clarunis - Universitäres Bauchzentrum Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marko Kraljevic, MD, Study chair, Clarunis - Universitäres Bauchzentrum BaselMarco Bueter, MD, Professor, Study chair, University Hospital Zurch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219787
- Sponsor's protocol ID
- 2019-02392
- Other IDs
- 2019
- Acronym
- SLIM
- Status last verified
- Nov 2023
- First submitted
- 3 Jan 2020
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kraljevic M, Schneider R, Wolnerhanssen B, Bueter M, Delko T, Peterli R. Different limb lengths in gastric bypass surgery: study protocol for a Swiss multicenter randomized controlled trial (SLIM). Trials. 2021 May 19;22(1):352. doi: 10.1186/s13063-021-05313-6.
PubMed 34011386
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT04219787
- Acronym / sponsor ID
- SLIM / 2019-02392
- Keywords
- Roux-en-Y Gastric Bypass, Biliopancreatic Limb Length
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Clarunis - Universitäres Bauchzentrum BaselUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 7 Jan 2020 (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.
Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients. One of the most frequently performed operations is the laparoscopic proximal Roux-en-Y gastric bypass (LRYGB). There is still lack of knowledge why some patients respond much better than others to an identically performed procedure. Therefore, a number of variations of this operation have been introduced over the past 50 years. Increasing the length of small bowel being bypassed has the potential to improve the effect of the operation but buries the risk of nutrient deficiencies. The metabolic effect of LRYGB occurs, in part, independently of weight loss. The mechanisms underlying metabolic improvement through metabolic surgery are not yet fully understood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long Biliopancreatic Limb LRYGB | Experimental | Procedure: Long BPL LRYGBLRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm. |
| Short Biliopancreatic Limb LRYGB | Active comparator | Procedure: Short BPL LRYGBStandard LRYGB with a 80 cm BPL and a 180 cm long AL. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- informed consent as documented by signature
- patients with BMI of 35 kg/m2 or higher who comply with the regulatory rules for bariatric surgery in Switzerland
Key exclusion criteria (10 listed)
- general contraindications to kind of surgery
- known or suspected non-compliance, drug or alcohol abuse
- inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant
- participation in another study
- age < 18 years or > 65 years
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 |
|---|---|---|
| Long BPL LRYGBAlso: LBPL LRYGBLRYGB with an 180 cm BPL and an AL of 80 cm. | Procedure or surgery | Long Biliopancreatic Limb LRYGB |
| Short BPL LRYGBAlso: SBPL LRYGBThe second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL. | Procedure or surgery | Short Biliopancreatic Limb LRYGB |
Primary outcome
Primary endpoint
Time frame: From baseline to 5 years after surgery.
Percent total weight loss (%TWL, superiority), while not leading to a larger nutritional de- ficiency rate (non-inferiority).
1 secondary outcome
Secondary endpoints
Time frame: From baseline to 5 years after surgery.
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 13 Nov 2023.
- Derived from this study: PubMed 34011386Kraljevic M, Schneider R, Wolnerhanssen B, Bueter M, Delko T, Peterli R. Different limb lengths in gastric bypass surgery: study protocol for a Swiss multicenter randomized controlled trial (SLIM). Trials. 2021 May 19;22(1):352. doi: 10.1186/s13063-021-05313-6.
- 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. This study is not recruiting at the moment.
Marko Kraljevic, MD study chair
Clarunis - Universitäres Bauchzentrum Basel
Marco Bueter, MD, Professor study chair
University Hospital Zurch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long BPL LRYGB and Short BPL LRYGB in people with Obesity, Morbid and Diabetes Mellitus, Type 2, run by Clarunis - Universitäres Bauchzentrum Basel at 1 site in Switzerland.
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 10 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 13 Nov 2023. 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 Switzerland. 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?
Primary endpoint (time frame: From baseline to 5 years after surgery.). 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 NCT04219787, 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 13 Nov 2023.