Single vs Standard Duodenal Switch for Obesity

(SADI Trial)

Recruiting at 1 trial location

Overseen By Suzy Laroche

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: IBD, Cirrhosis, Ulcers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure with immediate post-operative care

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical methods for significant weight loss and improved Type 2 Diabetes management. It compares a new, simpler version of a surgery called the Single Anastomosis Duodenal Switch (SADI-S or Loop Duodenal Switch) with the traditional method, the Standard Duodenal Switch (Biliopancreatic Diversion with Duodenal Switch or BPD-DS), to determine which is safer and more effective over time. Candidates for this trial include individuals eligible for weight-loss surgery with a BMI of 35 or higher, excluding those with certain health conditions like inflammatory bowel disease or severe heart problems. As an unphased trial, this study allows patients to contribute to groundbreaking research in surgical weight-loss methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Single Anastomosis Duodenal Switch (SADI-S) is generally safe for patients. Studies indicate that SADI-S offers similar short-term results for weight loss and health improvements as the traditional Duodenal Switch (DS). This means it not only aids in weight loss but also helps manage health issues like Type 2 Diabetes.

The SADI-S was designed to be simpler than some other weight loss surgeries, potentially making it easier on the body. The American Society for Metabolic and Bariatric Surgery supports it, indicating confidence in its safety and effectiveness.

For those considering participation in a clinical trial for this treatment, these findings suggest it is well-tolerated by patients. However, as with any medical procedure, discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Single Anastomosis Duodenal Switch (SADI) for obesity because it offers a simpler surgical approach compared to the standard duodenal switch. Unlike traditional methods that involve multiple connections in the digestive tract, SADI simplifies this by using just one connection, which may reduce surgery time and complications. Additionally, SADI includes a longer common channel, which might improve nutrient absorption and reduce the risk of nutritional deficiencies. These features could make it a more appealing option for patients seeking effective weight loss with potentially fewer side effects.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that the Single Anastomosis Duodenal Switch (SADI-S) surgery, one of the procedures studied in this trial, effectively promotes significant and lasting weight loss. It also addresses obesity-related health issues, such as diabetes. SADI-S is simpler than some other surgeries, like the Roux-en-Y gastric bypass, and can lead to greater weight loss over time. After this surgery, individuals often experience reduced hunger and increased fullness, aiding in weight control. Overall, SADI-S presents a promising option for managing obesity and improving related health problems. The trial will also evaluate the Standard Duodenal Switch (BPD-DS) to compare its effectiveness and outcomes with SADI-S. ^{2 3 4 6 7}

Who Is on the Research Team?

Laurent Biertho, MD

Principal Investigator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 who meet the criteria for bariatric surgery with a BMI≥35 and can give informed consent. It's not suitable for those with psychological issues affecting treatment compliance, recent substance abuse, gastrointestinal inflammatory diseases, severe organ disease, past stomach surgeries, Type 1 Diabetes or pregnancy.

Inclusion Criteria

Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35

Give written informed consent

Exclusion Criteria

You have a psychological issue that may make it difficult for you to understand and follow the study instructions.

You have used illegal drugs or consumed alcohol excessively within the past 6 months.

You have a history of inflammatory diseases in your stomach or intestines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the Biliopancreatic diversion with Duodenal Switch (BPD-DS) or the Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy

Surgical procedure with immediate post-operative care

Follow-up

Participants are monitored for safety, effectiveness, and outcomes such as excess weight loss, protein deficiency, and comorbidity remission

60 months

Long-term follow-up

Extended monitoring for mortality rate, complication rate, and quality of life changes

60 months

What Are the Treatments Tested in This Trial?

Interventions

• Single Anastomosis Duodenal Switch
• Standard Duodenal Switch

Trial Overview The study compares two weight loss surgeries: Single Anastomosis Duodenal Switch (a simplified technique) versus the Standard Duodenal Switch. The goal is to see which procedure offers better outcomes in terms of weight loss and diabetes remission while assessing long-term nutritional effects.

How Is the Trial Designed?

Group I: SADI Experimental Treatment 1 Intervention

Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy, including a 250cm common channel

Group II: BPD-DS Active Control 1 Intervention

Biliopancreatic diversion with Duodenal Switch (BPD-DS), with Sleeve gastrectomy, including a 100cm common channel and 150cm stric alimentary limb

Single Anastomosis Duodenal Switch is already approved in United States, European Union for the following indications:

Approved in United States as SADI-S for:

• Obesity
• Type 2 Diabetes Mellitus

Approved in European Union as SADI-S for:

• Obesity
• Type 2 Diabetes Mellitus

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Collaborator

Trials

26

Recruited

6,300+

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Collaborator

Trials

37

Recruited

9,700+

Published Research Related to This Trial

The Single Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy (SADI-S) is a safe and effective bariatric surgery, with a severe complication rate of 7.8% and a low mortality rate of 0.4% within 90 days post-surgery, based on a study of 232 patients.

Patients undergoing direct SADI-S experienced significantly greater excess weight loss (77.3%) compared to those who had a two-step procedure (59.3%), indicating that the direct approach may be more beneficial for achieving weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct and two-step single anastomosis duodenal switch (SADI-S): Unicentric comparative analysis of 232 cases. Admella, V., Osorio, J., Sorribas, M., et al.[2021]

In a meta-analysis of 2,029 patients who underwent single anastomosis duodenal-ileal bypass with sleeve (SADI-S), the incidence of bile reflux was found to be very low at 1.23%, indicating that this surgical method may have a favorable safety profile regarding bile reflux complications.

The analysis included seven studies with a mean follow-up of 10.3 months, suggesting that while bile reflux is not a significant issue in the short term, further long-term studies are necessary to fully understand the implications of SADI-S.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bile Reflux After Single Anastomosis Duodenal-Ileal Bypass with Sleeve (SADI-S): a Meta-analysis of 2,029 Patients. Portela, R., Marrerro, K., Vahibe, A., et al.[2022]

The single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) procedure is safe and shows similar short-term outcomes in weight loss and resolution of diabetes compared to the classic duodenal switch (DS) procedure, based on a study of 62 patients.

SADI-S has a shorter operative time than DS and results in a higher complete remission rate for diabetes (91% after SADI-S vs. 50% after DS), while also showing fewer deficiencies in fat-soluble vitamins, particularly vitamin D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S): short-term outcomes from a prospective cohort study. Andalib, A., Bouchard, P., Alamri, H., et al.[2021]

Single-anastomosis duodeno-ileal switch (SADIS) shows promising results for weight loss and resolution of obesity-related comorbidities, with an average excess weight loss of 85% at 2 years and high resolution rates for conditions like type 2 diabetes (74.1%) and hypertension (96.3%) among 581 patients studied.

Despite its effectiveness, SADIS is associated with a significant risk of nutritional deficiencies, particularly in vitamin A, selenium, and iron, with up to 34% of patients experiencing protein malnutrition, highlighting the need for careful nutritional monitoring post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Anastomosis Duodeno-Ileal Switch (SADIS): A Systematic Review of Efficacy and Safety. Shoar, S., Poliakin, L., Rubenstein, R., et al.[2018]

The single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) shows promising results with a low early complication rate of 7.3% and no postoperative deaths among 1,041 patients studied across 19 publications.

Patients experienced significant weight loss, with a mean 1-year percentage of excess weight loss (%EWL) of 78.7%, but there is still limited long-term data and no definitive evidence favoring SADI-S over traditional methods, despite indications of fewer malabsorption-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The single anastomosis duodenal switch modifications: a review of the current literature on outcomes. Topart, P., Becouarn, G.[2018]

In a study of 460 patients undergoing either biliopancreatic diversion with duodenal switch (BPD-DS) or single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), BPD-DS resulted in greater total body weight loss (TBWL) at 2 years, but both procedures had similar overall complication rates (14% for BPD-DS vs 18% for SADI-S).

SADI-S had a shorter operative time compared to BPD-DS (140.85 minutes vs 167.25 minutes), but it also led to more emergency department visits (17% vs 7%), indicating a potential trade-off between quicker surgery and post-operative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single- Versus Double-Anastomosis Duodenal Switch: Outcomes Stratified by Preoperative BMI. Lind, RP., Ghanem, M., Teixeira, AF., et al.[2022]

In a study of 16 patients who underwent a single-anastomosis duodenoileal bypass (SADI) after sleeve gastrectomy, there were no postoperative complications, demonstrating the safety of this surgical option.

Two years post-surgery, patients experienced an impressive average excess weight loss of 72%, along with significant improvements in co-morbidities: 88% remission for diabetes, 60% for hypertension, and 40% for dyslipidemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-anastomosis duodenoileal bypass as a second step after sleeve gastrectomy. Sánchez-Pernaute, A., Rubio, MÁ., Conde, M., et al.[2015]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39834997/

Outcomes of Single Anastomosis Duodeno-Ileal Bypass ... SADI-S effectively achieves substantial and sustained weight loss with high comorbidity resolution in individuals with high BMI.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673625010700

Efficacy and safety of single-anastomosis duodeno-ileal ... SADI-S was proposed as a less complex alternative with the potential to achieve greater weight loss than Roux-en-Y gastric bypass (RYGB), a long ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11745527/

Outcomes of Single Anastomosis Duodeno-Ileal Bypass ... SADI-S effectively achieves substantial and sustained weight loss with high comorbidity resolution in individuals with high BMI. While ...

4. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01070-0/abstract

Efficacy and safety of single-anastomosis duodeno-ileal ... SADI-S showed superior weight loss compared with RYGB at 2 years, with a similar safety profile. Funding. French Ministry of Health (Direction ...

5. asmbs.org asmbs.org/condition_procedures/single-anastomosis-duodeno-ileal-bypass-with-sleeve-gastrectomy/

Single Anastomosis Duodeno-Ileal Bypass with Sleeve ... This surgery offers good weight loss along with less hunger, more fullness, blood sugar control and diabetes improvement.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33158766/

Single anastomosis duodeno-ileal bypass with sleeve ... Conclusions: The SADI-S procedure is safe, and its short-term outcomes, including weight loss and the resolution of co-morbidities, are similar to those of DS.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02792166?term=SADI%20SLEEVE&rank=2

Single Anastomosis Duodeno-ileal Bypass With Sleeve ... SADI -S involves creating a sleeve gastrectomy but simplifies the bypass part of the BPD-DS by a single anastomosis of a loop of jejunum at 250cm from the ...