ObesitySADINCT04767490
Single Anastomosis Versus Standard Duodenal Switch
A study testing Standard Duodenal Switch and Single Anastomosis Duodenal Switch in people with Obesity and Morbid Obesity, run by Laval University at 1 site in Canada.
Trial summary
Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid Obesity
- What is being tested?
- Standard Duodenal Switch and Single Anastomosis Duodenal Switch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2015to 1 Sep 2026
- 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
- Age ≥18 years and ≤60 years
- Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35
- Give written informed consent
Who cannot join
- Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:
- Presence of the following baseline comorbidities:
- Inflammatory bowel disease (IBD),
- Cirrhosis
- History of gastric or duodenal ulcers
- Preoperative hypoalbuminemia (<35 g/L)
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- History of severe renal, hepatic, cardiac or pulmonary disease
- Past esophageal, gastric or bariatric surgery
- Type 1 Diabetes
- Pregnancy
- Evidence of psychological problem that may affect the capacity to understand the project and to comply with the medical recommendations
- History of drug use or alcohol abuse in the last 6 months
- History of gastro-intestinal inflammatory diseases
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5
Suzy Laroche, 418-656-8711 ext. 3841, suzy_laroche@ssss.gouv.qc.ca
Laurent Biertho, MD
About this study
Official title: Single Anastomosis Versus Standard Duodenal Switch - a Prospective Randomized Single-blinded Trial
Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion.
Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.
The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.
Read the detailed description
Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Our team, with more than 4000 BPD-DS performed since the early 1990's, is recognized internationally for its expertise with this specific procedure.
Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.
This new procedure, called Single Anastomosis Duodenal Switch has the potential benefit of decreasing the complexity of the standard BPD-DS by avoiding one of the two intestinal anastomoses usually needed. This could potentially decrease the rate of peri-operative complications and increase access to this type of surgery.
However, the length of the common channel (250cm) is more than doubled compared to standard BPD-DS, which could also change significantly the outcomes of the procedure itself. Indeed, the length of the common channel conditions the absorption of fat and fat-soluble vitamins.
Currently, the scientific literature regarding this procedure is scarce, with only one author who published his 2-years outcomes, in a cohort study of 100 patients. In addition, this report presents major limitations. In example, the length of the omega loop was increased from 200 to 250cm during the course of the study, in order to decrease the rate of protein deficiency and reoperation for malnutrition. This and other limitations make it hard to assess the actual results of the technique.
The overall objective of this study is to assess in a stronger study design (i.e. a prospective randomized single blinded trial), the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.
- Conditions
- Obesity, Morbid Obesity
- Being tested
- Standard Duodenal Switch, Single Anastomosis Duodenal Switch
- Keywords
- bariatric surgery
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Duodenal SwitchProcedure or surgery
Also called BPD-DS
Single Anastomosis Duodenal SwitchProcedure or surgery
Also called SADI
| Study group | Role | What they receive |
|---|---|---|
| BPD-DS | Active comparator | Biliopancreatic diversion with Duodenal Switch (BPD-DS), with Sleeve gastrectomy, including a 100cm common channel and 150cm stric alimentary limb Receives: Procedure: Standard Duodenal Switch |
| SADI | Experimental | Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy, including a 250cm common channel Receives: Procedure: Single Anastomosis Duodenal Switch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess weight loss
Excess weight loss at 2 years of follow-up
%EWL (Excess weight loss based on an ideal BMI = 25.) and change in BMI as compared to preoperative reference values
Measured: 2 years
Rate of protein deficiency or insufficiency
Rate of protein deficiency (<35gr/l) or insufficiency (<30gr/l)
Measured: from baseline up to 60 months
Mortality rate
Rate of mortality
Measured: from baseline up to 60 months
BMI
change in BMI at 2 years follow-up as compared to preoperative reference values
Measured: 2 years
Secondary outcomes (9)
Complication rate
overall and surgery-specific complications
Measured: from baseline up to 60 months
Cure rate of comorbidities
Remission rate for comorbidities, including T2D, Hypertension, dyslipidemia, sleep apnea
Measured: from baseline up to 60 months
Rate of minerals and vitamin deficiencies
Rate of deficiency and insufficiency in mineral and vitamins
Measured: from baseline up to 60 months
Body composition by bioimpedance measures
body fat composition (%) assessed by biompedance
Measured: from baseline up to 60 months
Change in quality of life
36-item short form survey score from 0 to 100
Measured: from baseline up to 60 months
Change in quality of life
Bariatric Analysis and Reporting Outcomes System score from -7 to 9
Measured: from baseline up to 60 months
Change in quality of life
Laval Questionnaire score from 0 to 7
Measured: from baseline up to 60 months
Change in quality of life
GastroIntestinal Quality of Life Index from 0 to 144
Measured: from baseline up to 60 months
Change in gatroesophageal reflux symptom
GastroEsophageal Reflus Disease Score from 0 to 72
Measured: from baseline to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Sep 2015
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Responsible party
- Principal investigator, Laurent Biertho, Laval University
- Investigators
- Laurent Biertho, MD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767490
- Sponsor's protocol ID
- SADI
- Acronym
- SADI
- Status last verified
- Aug 2024
- First submitted
- 23 Mar 2018
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Anastomosis Versus Standard Duodenal Switch - a Prospective Randomized Single-blinded Trial
- ClinicalTrials.gov ID
- NCT04767490
- Acronym / sponsor ID
- SADI / SADI
- Conditions
- Obesity, Morbid Obesity
- Keywords
- bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 23 Feb 2021 (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.
Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion.
Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.
The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.
Detailed description
Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Our team, with more than 4000 BPD-DS performed since the early 1990's, is recognized internationally for its expertise with this specific procedure.
Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.
This new procedure, called Single Anastomosis Duodenal Switch has the potential benefit of decreasing the complexity of the standard BPD-DS by avoiding one of the two intestinal anastomoses usually needed. This could potentially decrease the rate of peri-operative complications and increase access to this type of surgery.
However, the length of the common channel (250cm) is more than doubled compared to standard BPD-DS, which could also change significantly the outcomes of the procedure itself. Indeed, the length of the common channel conditions the absorption of fat and fat-soluble vitamins.
Currently, the scientific literature regarding this procedure is scarce, with only one author who published his 2-years outcomes, in a cohort study of 100 patients. In addition, this report presents major limitations. In example, the length of the omega loop was increased from 200 to 250cm during the course of the study, in order to decrease the rate of protein deficiency and reoperation for malnutrition. This and other limitations make it hard to assess the actual results of the technique.
The overall objective of this study is to assess in a stronger study design (i.e. a prospective randomized single blinded trial), the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPD-DS | Active comparator | Procedure: Standard Duodenal SwitchBiliopancreatic diversion with Duodenal Switch (BPD-DS), with Sleeve gastrectomy, including a 100cm common channel and 150cm stric alimentary limb |
| SADI | Experimental | Procedure: Single Anastomosis Duodenal SwitchSingle-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy, including a 250cm common channel |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥18 years and ≤60 years
- Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35
- Give written informed consent
Key exclusion criteria (13 listed)
- Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:
- Presence of the following baseline comorbidities:
- Inflammatory bowel disease (IBD),
- Cirrhosis
- History of gastric or duodenal ulcers
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 Duodenal SwitchAlso: BPD-DS | Procedure or surgery | BPD-DS |
| Single Anastomosis Duodenal SwitchAlso: SADI | Procedure or surgery | SADI |
Primary outcome
Excess weight loss
Time frame: 2 years
Excess weight loss at 2 years of follow-up %EWL (Excess weight loss based on an ideal BMI = 25.) and change in BMI as compared to preoperative reference values
Rate of protein deficiency or insufficiency
Time frame: from baseline up to 60 months
Rate of protein deficiency (<35gr/l) or insufficiency (<30gr/l)
Mortality rate
Time frame: from baseline up to 60 months
Rate of mortality
BMI
Time frame: 2 years
change in BMI at 2 years follow-up as compared to preoperative reference values
9 secondary outcomes
Complication rate
Time frame: from baseline up to 60 months
Cure rate of comorbidities
Time frame: from baseline up to 60 months
Rate of minerals and vitamin deficiencies
Time frame: from baseline up to 60 months
Body composition by bioimpedance measures
Time frame: from baseline up to 60 months
Change in quality of life
Time frame: from baseline up to 60 months
Change in quality of life
Time frame: from baseline up to 60 months
Change in quality of life
Time frame: from baseline up to 60 months
Change in quality of life
Time frame: from baseline up to 60 months
Change in gatroesophageal reflux symptom
Time frame: from baseline to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- 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.
Laurent Biertho, MD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Duodenal Switch and Single Anastomosis Duodenal Switch in people with Obesity and Morbid Obesity, run by Laval University at 1 site in Canada.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 9 Aug 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzy Laroche (418-656-8711 ext. 3841, suzy_laroche@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess weight loss (time frame: 2 years). The study lists 4 primary outcomes in all. 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 9 Aug 2024; AzTrials last refreshed its copy on 3 Nov 2026.