Metabolic Surgery for Obesity

Recruiting at 1 trial location

Overseen By Mélanie Nadeau, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Pregnancy, Cirrhosis, Abnormal bowel habits, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

151 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical options for individuals needing a second weight-loss surgery after a sleeve gastrectomy. It compares the Single-Anastomosis Duodenoileal Switch (SADI-S, also known as Single-anastomosis duodenal switch) with the traditional Duodenal Switch (DS) to determine which one aids weight loss more effectively and has fewer side effects, such as nutritional issues. Participants who had a sleeve gastrectomy at least 18 months ago and are experiencing weight regain may be suitable candidates. The trial aims to determine if SADI-S is as effective as the standard DS but with fewer complications. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance surgical options for future patients.

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 Duodenoileal Switch (SADI-S) can be an effective weight loss surgery, often resulting in significant weight loss and improvement in obesity-related health issues. However, it carries risks. Studies indicate that SADI-S has a higher chance of complications shortly after surgery compared to procedures like gastric bypass or sleeve gastrectomy, including digestive problems and nutritional deficiencies.

Similarly, the Standard Duodenal Switch (BPD-DS) is a more complex surgery with its own risk of complications, potentially leading to severe nutritional deficiencies and other side effects.

Both surgeries target individuals who have undergone a sleeve gastrectomy but require further weight loss. Anyone considering these options should carefully weigh the benefits and risks and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the single-anastomosis duodenal switch because it offers a potentially more efficient approach to metabolic surgery for obesity compared to the standard biliopancreatic diversion with duodenal switch. Unlike the traditional method that involves two anastomoses and a longer common channel, this technique simplifies the process with just one anastomosis and a shorter common channel, which could reduce surgical complexity and recovery time. Additionally, this approach might enhance weight loss and improve metabolic outcomes by altering the digestive tract more effectively.

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

Research has shown that the Single-Anastomosis Duodeno-Ileal Switch (SADI-S), one of the procedures studied in this trial, effectively promotes significant and lasting weight loss. Studies also indicate it improves obesity-related health issues, such as diabetes. SADI-S is simpler and quicker to perform than other surgeries, potentially reducing the risk of complications. With fewer surgical connections, the procedure may lead to an easier recovery. This trial will compare SADI-S to the standard duodenal switch, another procedure under study, as a second-stage surgery after sleeve gastrectomy. Although specific data on SADI-S's use after sleeve gastrectomy is not yet available, its benefits in initial surgeries are promising. ^{1 2 6 7 8}

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 individuals who had sleeve gastrectomy at least 18 months ago, still qualify for bariatric surgery based on their BMI and health conditions, or have not lost enough weight or regained a significant amount. It's not for those who are pregnant, have cirrhosis, general contraindications to bariatric surgery, abnormal bowel habits like IBS or IBD, or a BMI under 35.

Inclusion Criteria

I qualify for weight loss surgery based on my BMI or I haven't lost enough weight/have regained weight after previous surgery.

Exclusion Criteria

You are pregnant.

I have irregular bowel habits or a diagnosed bowel condition.

I am not a candidate for weight loss surgery due to health risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo revisional surgery using either SADI-S or standard DS after sleeve gastrectomy

12 months

Regular follow-up visits as per surgical protocol

Follow-up

Participants are monitored for safety, effectiveness, and secondary outcomes such as nutritional status and quality of life

60 months

Periodic assessments including blood tests and quality of life surveys

What Are the Treatments Tested in This Trial?

Interventions

• Single-anastomosis duodenal switch
• Standard duodenal switch

Trial Overview The study compares two surgeries for managing obesity after initial sleeve gastrectomy failure: the standard duodenal switch (DS) and the newer single-anastomosis duodenal switch (SADI-S). Participants will be randomly assigned to one of these procedures in a double-blind setup to measure which is more effective at weight loss without causing as many complications.

How Is the Trial Designed?

Group I: Single-anastomosis duodeno-ileal anastomosis Experimental Treatment 1 Intervention

Patient randomized for a single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)

Group II: biliopancreatic diversion with duodenal switch Active Control 1 Intervention

Patient 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 switch is already approved in European Union, United States for the following indications:

Approved in European Union as SADI-S for:

• Obesity
• Type 2 Diabetes
• Dyslipidemia
• Obstructive Sleep Apnea

Approved in United States as SADI-S for:

• Obesity
• Type 2 Diabetes
• Revisional surgery after failed sleeve gastrectomy

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+

Institut universitaire de cardiologie et de pneumologie de Québec

Collaborator

Trials

4

Recruited

2,000+

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 study of 164 patients undergoing single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), there were no reported deaths, indicating a high safety profile for this surgical procedure over the long term.

At 10 years post-surgery, patients experienced significant weight loss (80% excess weight loss) and improvements in type 2 diabetes management, with a reduction in insulin dependence from 41 patients preoperatively to 12 at 10 years, demonstrating the efficacy of SADI-S in addressing obesity and related comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Results of Single-Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy (SADI-S). Sánchez-Pernaute, A., Herrera, MÁR., Ferré, NP., 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 bypass with sleeve gastrectomy (SADI-S) shows promising results in terms of weight loss and metabolic outcomes, with a total weight loss of 37.3% compared to 35.6% for other malabsorptive procedures, based on a review of 16 studies involving 3319 patients.

SADI-S has a shorter operative duration and post-operative stay, and it trends towards fewer complications compared to other malabsorptive procedures, suggesting it may be a safer option for patients, although long-term outcomes are still needed for a complete assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Metabolic Outcomes Following SADI-S: a Systematic Review and Meta-analysis. Verhoeff, K., Mocanu, V., Zalasky, A., et al.[2022]

In a study comparing single-anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S) to Roux-en-Y gastric bypass (RYGB) in Chinese patients with diabetes and a BMI under 35 kg/m2, SADI-S resulted in significantly greater weight loss after 2 years (p = 0.017).

Both SADI-S and RYGB achieved similar rates of complete remission of type 2 diabetes (76.5% for SADI-S and 82.4% for RYGB), with no severe complications reported, indicating that SADI-S is a safe and effective option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Comparison of SADI-S Versus RYGB in Chinese with Diabetes and BMI< 35kg/m2: a Propensity Score Adjustment Analysis. Sang, Q., Wang, L., Wuyun, Q., et al.[2022]

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 was found to be highly effective for Chinese patients with diabetes and a BMI under 35 kg/m2, resulting in an average total body weight loss of 26.26% over 2 years.

Out of the 23 patients evaluated for diabetes remission, 20 achieved complete remission, indicating that SADI-S not only aids in weight loss but also significantly improves diabetes outcomes without serious complications during the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary SADI-S in Chinese with Diabetes and BMI < 35 kg/m2: a Retrospective Study with 2-Year Follow-up. Wang, L., Wuyun, Q., Du, D., et al.[2021]

In a study of 121 super-obese patients (BMI ≥ 50 kg/m²) who underwent the SADI-S procedure, the complication rate was low, with only 3.3% experiencing complications both at 30 days and later, indicating the procedure's safety.

At a median follow-up of 31 months, patients achieved a median excess weight loss of 79.8%, demonstrating the procedure's effectiveness in promoting significant weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S): experience from a high-bariatric volume center. Pennestrì, F., Sessa, L., Prioli, F., et al.[2022]

In a study of 91 patients undergoing single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), the procedure demonstrated a low complication rate of 4.3% in the short term and 0% in the long term, with no reported mortality.

Patients experienced significant weight loss, averaging a reduction of 15.2 kg/m2 at 12 months and 17.2 kg/m2 at 24 months, along with high resolution rates for conditions like obstructive sleep apnea and type 2 diabetes (94% each).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Outcomes of Primary SADI-S: an Australian Experience. Surve, A., Rao, R., Cottam, D., et al.[2021]

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. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728925001376

Single-anastomosis duodenal-ileal bypass with sleeve ... Single-anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S) offers excellent weight loss and metabolic outcomes in patients with obesity and type ...

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

Efficacy and safety of single-anastomosis duodeno-ileal ... We conducted a multicentre randomised trial, with the hypothesis that SADI-S could be more effective than RYGB at 2-year follow-up.

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

Single Anastomosis Duodeno-Ileal Bypass with Sleeve ... While similar to the BPD-DS, the SADI-S is simpler and takes less time to perform as there is only one surgical bowel connection. The Procedure. The operation ...

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

Efficacy and safety of single-anastomosis duodeno-ileal ... SADI-S can be considered both as a primary procedure and as a revisional option after sleeve gastrectomy, offering greater weight loss and good ...

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

Single Anastomosis Duodeno-ileal Bypass With Sleeve ... Single Anastomosis Duodenal Switch versus Classic Duodenal Switch: Long-term Outcomes from a Prospective Comparative Cohort Study. Obes Surg. 2023 Dec;33(12): ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36198497/

Single-anastomosis duodenoileal bypass with sleeve in ... SADI-S, in its early adoption stage, has a higher incidence of perioperative complications than RYGB and SG. It has comparable 30-day outcomes to BPD/DS.