Obesity, MorbidNCT07115836
Standard Versus "Single Loop" Bypass After Parietal Gastrectomy
A study testing Standard duodenal switch and Single-anastomosis duodenal switch in people with Obesity, Morbid and Obesity, run by Laval University at 1 site in Canada.
Trial summary
Bilio-pancreatic bypass (BPD-DS) is the most effective type of bariatric surgery in terms of weight loss and treatment of obesity-related comorbidities such as type 2 diabetes. Nevertheless, the spread of this procedure is limited by the technical difficulties and long-term nutritional complications inherent in this… Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 63 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jan 2017to 6 Jan 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
- Patients who had a parietal gastrectomy more than 18 months ago and
- Who still meet NIH criteria for bariatric surgery (BMI ≥ 35kg/m2 with associated disease or BMI ≥ 40kg/m2) or
- Have lost < 50% of their excess weight, or
- Have significant weight regain (≥ 20% EWL)
- Accepting long-term care and follow-up and willing to participate in this study after informed consent
Who cannot join
- Other bariatric procedures apart from parietal gastrectomy.
- Psychiatric illness not stabilized for more than 6 months
- Severe illness with life-threatening consequences within 5 years
- Diagnosis of cancer within the last 3 years
- Chronic digestive disorders (chronic diarrhea, inflammatory diseases, cirrhosis, intestinal resections, functional abdominal pain)
- Pregnancy or desire for pregnancy within 2 years
- Intellectual retardation making consent impossible or patient under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard Versus "Single Loop" Bypass After Parietal Gastrectomy: a Randomized Double-blind Study
Bilio-pancreatic bypass (BPD-DS) is the most effective type of bariatric surgery in terms of weight loss and treatment of obesity-related comorbidities such as type 2 diabetes. Nevertheless, the spread of this procedure is limited by the technical difficulties and long-term nutritional complications inherent in this operation.
Recently, a simplified "Duodenal Switch" technique has been proposed. This technique is known as "Single Anastomosis Duodeno-Ileal bypass" (SADI) and involves connecting the duodenum to the ileum, 250 cm upstream of the ileo-caecal valve, via an "omega" loop. This surgery is technically simpler and possibly less risky (particularly from a nutritional point of view) than the "standard" technique developed at the IUCPQ. This explains the enthusiasm in the surgical community for SADI, although the scientific evidence is very limited. The investigator has therefore initiated a prospective randomized study to compare standard bypass with single loop bypass as primary surgery.
Read more
In this study, the investigator aims to evaluate the results of SADI versus standard bypass, as 2nd-stage surgery after parietal gastrectomy.
The hypothesis is that SADI will be accompanied by fewer digestive and nutritional side effects, but also by a lower weight loss and a lower rate of recovery from comorbidities.
- Conditions
- Obesity, Morbid, Obesity
- Being tested
- Standard duodenal switch, Single-anastomosis duodenal switch
- Keywords
- Bariatric surgery
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard duodenal switchProcedure or surgery
Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)
Single-anastomosis duodenal switchProcedure or surgery
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 duodenal-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.
Weight loss
% Excess weights loss
Measured: from baseline to 60 months
Secondary outcomes (14)
Mortality rate
Mortality rate
Measured: from baseline to 60 months
Early complications
Complication (≤30 days) graded with Clavien classification
Measured: from baseline to 30 days
Late complications
Complication (>30 days to 60 months) ga=raded with Clavien classification
Measured: from 30 days to 60 months
Operating time
Operating time in minutes
Measured: baseline
Blood loss
Peroperative blood loss (ml) as reported in the operating room
Measured: baseline
Hospital stay
length of hospital stay (days)
Measured: baseline
Change in quality of life (QLaval)
Change in quality of life assessed by the Laval questionnaire evaluating 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life
Measured: from baseline to 60 months
Change in quality of life (SF36)
change in quality of life assessed with the 36-item short form survey evaluating quality of life on a scale form 0 to 100, higher scores indicate better quality of life
Measured: from baseline to 60 months
Digestive side effects (GERD)
Evaluation of gastro-oesophageal reflux symptoms using the GERD Score questionnaire, on a scale from 0 to 72, higher scores indicating greater symptoms
Measured: from baseline to 60 months
Digestive side effects (LARS)
Evaluation of bowel function using the LARS questionnaire, on a scale from 0 to 42, with higher scores indicating greater symptoms
Measured: baseline to 60 months
Digestive side effect (GIQLI)
Evaluation of digestive side effect using the Laval digestive problems evaluation questionnaire, on a scale from 0 to 144, with higher scores indicating less negative impact of symptoms
Measured: from baseline to 60 months
Malnutrition rate
Malnutrition rate using albuminemia (mild 30-34.9g/L; moderate 25-29.9g/L; severe <25g/L)
Measured: from baseline to 60 months
Nutrient deficiency rate
Nutrient deficiency rate based on blood analysis of vitamine A, vitamin D, vitamin B12, Calcium, magnsium, phosphorus, iron, ferritin, TIBC and parathormone and the required dose of supplements
Measured: from baseline to 60 months
Resolution of associated comorbidities
Type 2 diabetes, hypertension, sleep apnea and dislipidemia evolution are evaluated according to treatment, symptoms, vital signs and blood test results to determine whether there has been resolution, improvement, no change, deterioration, or recurrence of the condition according to the criteria of the American Society for Metabolic \& Bariatric Surgery.
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 posted11 Aug 2025
- Study start6 Jan 2017
- Primary completion6 Jan 2025
- Study completion6 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Model description
- This is a single-center double-blind randomized trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Institut universitaire de cardiologie et pneumologie de Québec
- Responsible party
- Principal investigator, Laurent Biertho, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115836
- Sponsor's protocol ID
- Second stage SADI, pilot study
- Status last verified
- Dec 2025
- First submitted
- 4 Aug 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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
- Standard Versus "Single Loop" Bypass After Parietal Gastrectomy: a Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT07115836
- Acronym / sponsor ID
- Second stage SADI, pilot study
- Conditions
- Obesity, Morbid, Obesity
- Keywords
- Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Fondation de l'Institut universitaire de cardiologie et pneumologie de Québec
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2028 (estimated)
- First posted
- 11 Aug 2025 (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 bypass (BPD-DS) is the most effective type of bariatric surgery in terms of weight loss and treatment of obesity-related comorbidities such as type 2 diabetes. Nevertheless, the spread of this procedure is limited by the technical difficulties and long-term nutritional complications inherent in this operation.
Recently, a simplified "Duodenal Switch" technique has been proposed. This technique is known as "Single Anastomosis Duodeno-Ileal bypass" (SADI) and involves connecting the duodenum to the ileum, 250 cm upstream of the ileo-caecal valve, via an "omega" loop. This surgery is technically simpler and possibly less risky (particularly from a nutritional point of view) than the "standard" technique developed at the IUCPQ. This explains the enthusiasm in the surgical community for SADI, although the scientific evidence is very limited. The investigator has therefore initiated a prospective randomized study to compare standard bypass with single loop bypass as primary surgery.
In this study, the investigator aims to evaluate the results of SADI versus standard bypass, as 2nd-stage surgery after parietal gastrectomy.
The hypothesis is that SADI will be accompanied by fewer digestive and nutritional side effects, but also by a lower weight loss and a lower rate of recovery from comorbidities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center double-blind randomized trial
| 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 duodenal-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 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who had a parietal gastrectomy more than 18 months ago and
- Who still meet NIH criteria for bariatric surgery (BMI ≥ 35kg/m2 with associated disease or BMI ≥ 40kg/m2) or
- Have lost < 50% of their excess weight, or
- Have significant weight regain (≥ 20% EWL)
- Accepting long-term care and follow-up and willing to participate in this study after informed consent
Key exclusion criteria (7 listed)
- Other bariatric procedures apart from parietal gastrectomy.
- Psychiatric illness not stabilized for more than 6 months
- Severe illness with life-threatening consequences within 5 years
- Diagnosis of cancer within the last 3 years
- Chronic digestive disorders (chronic diarrhea, inflammatory diseases, cirrhosis, intestinal resections, functional abdominal pain)
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 switchStandard 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 switchSingle-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel) | Procedure or surgery | Single-anastomosis duodenal-ileal anastomosis |
Primary outcome
Weight loss
Time frame: from baseline to 60 months
% Excess weights loss
14 secondary outcomes
Mortality rate
Time frame: from baseline to 60 months
Early complications
Time frame: from baseline to 30 days
Late complications
Time frame: from 30 days to 60 months
Operating time
Time frame: baseline
Blood loss
Time frame: baseline
Hospital stay
Time frame: baseline
Change in quality of life (QLaval)
Time frame: from baseline to 60 months
Change in quality of life (SF36)
Time frame: from baseline to 60 months
Digestive side effects (GERD)
Time frame: from baseline to 60 months
Digestive side effects (LARS)
Time frame: baseline to 60 months
Digestive side effect (GIQLI)
Time frame: from baseline to 60 months
Malnutrition rate
Time frame: from baseline to 60 months
Nutrient deficiency rate
Time frame: from baseline to 60 months
Resolution of associated comorbidities
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, Morbid and 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 5 inclusion and 7 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 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?
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 loss (time frame: from baseline to 60 months). 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.