Single vs Standard Duodenal Switch for Obesity

(SADI Trial)

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?

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.

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 the Single vs Standard Duodenal Switch for Obesity generally safe for humans?

The Single Anastomosis Duodenal Switch (SADI-S) is designed to be safer than the traditional duodenal switch by reducing complications like malnutrition and long surgery times. However, there is a risk of bile reflux, which is a condition where digestive fluid backs up into the stomach and esophagus, potentially causing discomfort. ^{1 2 3 4 5}

How does the Single Anastomosis Duodenal Switch treatment differ from other obesity treatments?

The Single Anastomosis Duodenal Switch (SADI-S) is a simplified version of the traditional duodenal switch surgery, designed to reduce complications like malnutrition and long surgery times while maintaining effective weight loss. It involves a single connection between the intestine and stomach, making it easier and quicker to perform compared to the more complex double-anastomosis approach. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Single Anastomosis Duodenal Switch (SADI-S) for obesity?

Research shows that the Single Anastomosis Duodenal Switch (SADI-S) is effective for weight loss and may have fewer side effects compared to the traditional duodenal switch. It is also considered easier and quicker to perform, making it a promising option for patients who have not achieved sufficient weight loss with other surgeries. ^{1 2 3 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) 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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The single anastomosis duodenal switch modifications: a review of the current literature on outcomes. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S): short-term outcomes from a prospective cohort study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Single Anastomosis Duodeno-Ileal Switch (SADIS): A Systematic Review of Efficacy and Safety. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Single-anastomosis duodenoileal bypass as a second step after sleeve gastrectomy. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Single- Versus Double-Anastomosis Duodenal Switch: Outcomes Stratified by Preoperative BMI. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

Direct and two-step single anastomosis duodenal switch (SADI-S): Unicentric comparative analysis of 232 cases. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Bile Reflux After Single Anastomosis Duodenal-Ileal Bypass with Sleeve (SADI-S): a Meta-analysis of 2,029 Patients. [2022]