Metabolic Surgery for Obesity

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

Trial Summary

What is the purpose of this trial?

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.

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.

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 improving conditions like type 2 diabetes, with results similar to other complex surgeries but with fewer complications. ^{1 2 3 4 5}

Is the metabolic surgery for obesity, known as SADI-S or similar names, generally safe for humans?

Research shows that the SADI-S procedure, a type of metabolic surgery for obesity, is generally considered safe with promising results in weight loss and health improvements. It was designed to reduce complications seen in similar surgeries, and studies have shown it to be safe and effective in the short term. ^{1 3 4 6 7}

How does the SADI-S treatment for obesity differ from other treatments?

The SADI-S treatment is a modified version of the duodenal switch surgery, designed to simplify the procedure and reduce complications like malnutrition and long surgery times, while still providing effective weight loss and diabetes remission. ^{1 2 4 8 9}

Research Team

Laurent Biertho, MD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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 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]

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 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]

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]

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]

References

1. 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]

2. United States 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. [2022]

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

Long-Term Results of Single-Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy (SADI-S). [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

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

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

Early Outcomes of Primary SADI-S: an Australian Experience. [2021]

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

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

7. Germany pubmed.ncbi.nlm.nih.gov

Single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S): experience from a high-bariatric volume center. [2022]

8. United States 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. [2021]

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

Evaluation of Metabolic Outcomes Following SADI-S: a Systematic Review and Meta-analysis. [2022]