ObesityNCT05242835
Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery
A study testing Standard duodenal switch and Single-anastomosis duodenal switch in people with Obesity and Obesity, Morbid, run by Laval University at 1 site in Canada.
Trial summary
Sleeve gastrectomy (SG) has become the most commonly performed weight loss surgery, accounting for 60% of all bariatric operations worldwide. While technically easier with less side-effects and nutritional risks than other operations, SG is also associated with a higher risk of failure (20 to 40%). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Obesity, Morbid
- 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
- 151 participants
- Where
- 1 siteCanada
- Study dates
- 3 Feb 2023to Mar 2027
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- had sleeve gastrectomy a minimum of 18 months before
- still meet the NIH criteria for bariatric surgery (BMI≥35kg/m2 with major comorbidities or BMI≥40kg/m2) or patients with EWL<50% or significant weight regain (≥20%EWL)
Who cannot join
- general contra-indication for bariatric surgery
- BMI<35kg/m2
- pregnancy
- cirrhosis
- abnormal bowel habits including irritable bowel syndrome and inflammatory bowel disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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
Sleeve gastrectomy (SG) has become the most commonly performed weight loss surgery, accounting for 60% of all bariatric operations worldwide. While technically easier with less side-effects and nutritional risks than other operations, SG is also associated with a higher risk of failure (20 to 40%). In such case, the most effective option consists in adding an intestinal bypass called the Biliopancreatic Diversion with Duodenal Switch (BPD-DS). This surgery is, however, technically challenging and yields a significant risk of complications, nutritional deficiencies or gastro-intestinal side-effects. Recently, a simplified version of the Standard DS, called Single-Anastomosis Duodenoileal Switch (SADI-S) was endorsed by surgical societies as one of the approved bariatric procedures. There is currently no prospective or randomized data to support the effectiveness of this new procedure, especially as a revisional approach. The Overall Objective of this randomized controlled trial project is to establish the clinical benefits of the SADI-S as a revisional surgery after SG, while also considering critical issues related to sex and gender. The investigator Overall Hypothesis is that the SADI-S represents a relevant revisional option for weight loss and metabolic recovery in women and men suffering from severe obesity who had a previous SG. The investigator propose to address the following research question.
Research Question: What are the clinical effects of SADI-S compared to standard DS when used as a revisional procedure after SG, in patients with obesity? Participants who need revisional surgery after SG will be enrolled in a prospective, randomized, double-blind (patient-evaluator), non-inferiority trial comparing SADI-S vs DS. The primary outcome will be 12-month excess weight loss. Secondary outcomes will be perioperative complications, risk of malnutrition, quality of life and gastrointestinal side effects. The investigator hypothesize that SADI-S offers similar weight loss compared to standard DS, but a lower risk of complications and nutritional deficiencies.
With the increase in the number of bariatric operations performed worldwide and the recent endorsement of the SADI-S as a regular procedure, reliable clinical data are urgently needed. The present proposal will directly address this knowledge gap.
- Conditions
- Obesity, Obesity, Morbid
- 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
Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)
Single-anastomosis duodenal switchProcedure or surgery
Also called SADI
Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)
| Study group | Role | What they receive |
|---|---|---|
| biliopancreatic diversion with duodenal switch | Active comparator | Patient randomized for a the standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb) Receives: Procedure: Standard duodenal switch |
| Single-anastomosis duodeno-ileal anastomosis | Experimental | Patient randomized for a single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (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
Percentage of excess weight loss mobilized in response to surgery
Measured: 12 month
Secondary outcomes (20)
Peroperative complications
Complications graded with Clavien classification
Measured: from baseline up to 60 months
Risk of malnutrition
Risk of malnutrition assessed through measurement of its risk being mild (albumin<35g\L), moderate (albumin<30g/L) or severe (albumin<25g/L)
Measured: from baseline to 60 months
Change in quality of life (SF-36)
36-item short form survey evaluating quality of life on a scale form 0 to 100
Measured: from baseline to 60 months
Change in quality of life (BAROS)
Bariatric Analyses and Reporting Outcomes System score form -7 to 9
Measured: from baseline to 60 months
Change in quality of life (QLaval)
Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7
Measured: from baseline to 60 months
Gastro-intestinal side effects
Evaluation of gastro-intestinal side effects with the Gastro-Intestinal Quality of Life Index from 0 to 144
Measured: from baseline to 60 months
Change in nutritional status (calcium)
Change in nutritional status based on blood analysis of calcium (mmol/L)
Measured: from baseline to 60 months
Change in nutritional status (ferritin)
Change in nutritional status based on blood analysis of ferritin (ug/L)
Measured: from baseline to 60 months
Change in nutritional status (TIBC)
Change in nutritional status based on blood analysis of TIBC (umol/L)
Measured: from baseline to 60 months
Change in nutritional status (iron)
Change in nutritional status based on blood analysis of iron (umol/L)
Measured: from baseline to 60 months
Change in nutritional status (prealbumin)
Change in nutritional status based on blood analysis of prealbumin (g/L)
Measured: from baseline to 60 months
Change in nutritional status (transferrin)
Change in nutritional status based on blood analysis transferrin (g/L)
Measured: from baseline to 60 months
Change in nutritional status (vitamin A)
Change in nutritional status based on blood analysis of vitamin A (umol/L)
Measured: from baseline to 60 months
Change in nutritional status (vitamin D3)
Change in nutritional status based on blood analysis of vitamin D3 (nmol/L)
Measured: from baseline to 60 months
Change in nutritional status (parathormone)
Change in nutritional status based on blood analysis parathormone (ng/L)
Measured: from baseline to 60 months
Change in food intake
Evaluation of the change in food intake using a web-based food frequency questionnaire (kcal/day)
Measured: from baseline to 60 months
Change in eating behavior
Change of eating behavior using the Three-Factor Eating Questionnaire evaluating cognitive restraint of eating on a scale from 0 to 20, disinhibition on a scale from 0 to 16 and hunger on a scale from 0 to 15
Measured: from baseline to 60 months
Change in food addiction
Change of eating behavior using the Yale Food Addiction Scale that includes a "symptom count" scale from 0 to 7 reflecting the number of addiction-like criteria endorsed and a dichotomous evaluation that indicates whether a threshold of three or more "symptoms" plus clinically significant impairment or distress has been met
Measured: from baseline to 60 months
Change in binge eating behavior
Change of eating behavior using the Binge Eating scale from 0 to 46
Measured: from baseline to 60 months
Evolution of obesity related diseases
Remission rate for comorbidities, including T2D, hypertension, dyslipidemia, sleep apnea according to the ASMBS definition of outcomes reporting
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 posted16 Feb 2022
- Study start3 Feb 2023
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 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
- NCT05242835
- Sponsor's protocol ID
- Second stage SADI
- Status last verified
- Dec 2025
- First submitted
- 25 Jan 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery
- ClinicalTrials.gov ID
- NCT05242835
- Acronym / sponsor ID
- Second stage SADI
- Conditions
- Obesity, Obesity, Morbid
- Keywords
- Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Feb 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.
Sleeve gastrectomy (SG) has become the most commonly performed weight loss surgery, accounting for 60% of all bariatric operations worldwide. While technically easier with less side-effects and nutritional risks than other operations, SG is also associated with a higher risk of failure (20 to 40%). In such case, the most effective option consists in adding an intestinal bypass called the Biliopancreatic Diversion with Duodenal Switch (BPD-DS). This surgery is, however, technically challenging and yields a significant risk of complications, nutritional deficiencies or gastro-intestinal side-effects. Recently, a simplified version of the Standard DS, called Single-Anastomosis Duodenoileal Switch (SADI-S) was endorsed by surgical societies as one of the approved bariatric procedures. There is currently no prospective or randomized data to support the effectiveness of this new procedure, especially as a revisional approach. The Overall Objective of this randomized controlled trial project is to establish the clinical benefits of the SADI-S as a revisional surgery after SG, while also considering critical issues related to sex and gender. The investigator Overall Hypothesis is that the SADI-S represents a relevant revisional option for weight loss and metabolic recovery in women and men suffering from severe obesity who had a previous SG. The investigator propose to address the following research question.
Research Question: What are the clinical effects of SADI-S compared to standard DS when used as a revisional procedure after SG, in patients with obesity? Participants who need revisional surgery after SG will be enrolled in a prospective, randomized, double-blind (patient-evaluator), non-inferiority trial comparing SADI-S vs DS. The primary outcome will be 12-month excess weight loss. Secondary outcomes will be perioperative complications, risk of malnutrition, quality of life and gastrointestinal side effects. The investigator hypothesize that SADI-S offers similar weight loss compared to standard DS, but a lower risk of complications and nutritional deficiencies.
With the increase in the number of bariatric operations performed worldwide and the recent endorsement of the SADI-S as a regular procedure, reliable clinical data are urgently needed. The present proposal will directly address this knowledge gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biliopancreatic diversion with duodenal switch | Active comparator | Procedure: Standard duodenal switchPatient randomized for a the standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb) |
| Single-anastomosis duodeno-ileal anastomosis | Experimental | Procedure: Single-anastomosis duodenal switchPatient randomized for a single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- had sleeve gastrectomy a minimum of 18 months before
- still meet the NIH criteria for bariatric surgery (BMI≥35kg/m2 with major comorbidities or BMI≥40kg/m2) or patients with EWL<50% or significant weight regain (≥20%EWL)
Key exclusion criteria (5 listed)
- general contra-indication for bariatric surgery
- BMI<35kg/m2
- pregnancy
- cirrhosis
- abnormal bowel habits including irritable bowel syndrome and inflammatory bowel disease
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-DSStandard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb) | Procedure or surgery | biliopancreatic diversion with duodenal switch |
| Single-anastomosis duodenal switchAlso: SADISingle-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel) | Procedure or surgery | Single-anastomosis duodeno-ileal anastomosis |
Primary outcome
Excess weight loss
Time frame: 12 month
Percentage of excess weight loss mobilized in response to surgery
20 secondary outcomes
Peroperative complications
Time frame: from baseline up to 60 months
Risk of malnutrition
Time frame: from baseline to 60 months
Change in quality of life (SF-36)
Time frame: from baseline to 60 months
Change in quality of life (BAROS)
Time frame: from baseline to 60 months
Change in quality of life (QLaval)
Time frame: from baseline to 60 months
Gastro-intestinal side effects
Time frame: from baseline to 60 months
Change in nutritional status (calcium)
Time frame: from baseline to 60 months
Change in nutritional status (ferritin)
Time frame: from baseline to 60 months
Change in nutritional status (TIBC)
Time frame: from baseline to 60 months
Change in nutritional status (iron)
Time frame: from baseline to 60 months
Change in nutritional status (prealbumin)
Time frame: from baseline to 60 months
Change in nutritional status (transferrin)
Time frame: from baseline to 60 months
Change in nutritional status (vitamin A)
Time frame: from baseline to 60 months
Change in nutritional status (vitamin D3)
Time frame: from baseline to 60 months
Change in nutritional status (parathormone)
Time frame: from baseline to 60 months
Change in food intake
Time frame: from baseline to 60 months
Change in eating behavior
Time frame: from baseline to 60 months
Change in food addiction
Time frame: from baseline to 60 months
Change in binge eating behavior
Time frame: from baseline to 60 months
Evolution of obesity related diseases
Time frame: from baseline to 60 months
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 8 Dec 2025.
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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.
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 Obesity, Morbid, 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. 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?
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?
Contact Mélanie Nadeau, MSc (418-656-8711 ext. 3490, melanie.nadeau@criucpq.ulaval.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: 12 month). 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 8 Dec 2025.