Metabolic Surgery for Obesity
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Laval University
Disqualifiers: Pregnancy, Cirrhosis, Abnormal bowel habits, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
13467How 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.
12489Eligibility 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 had sleeve gastrectomy surgery at least 18 months ago.
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.
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Single-anastomosis duodeno-ileal anastomosisExperimental Treatment1 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 switchActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Institut Universitaire de Cardiologie et de Pneumologie de QuébecQuebec City, Canada
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Who Is Running the Clinical Trial?
Laval UniversityLead Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University LavalCollaborator
Institut universitaire de cardiologie et de pneumologie de QuébecCollaborator
References
Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S): short-term outcomes from a prospective cohort study. [2021]Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification of the classic duodenal switch (DS). These modifications are intended to address concerns about DS, including malnutrition, longer operative times, and technical challenges, while preserving the benefits.
Retrospective Comparison of SADI-S Versus RYGB in Chinese with Diabetes and BMI< 35kg/m2: a Propensity Score Adjustment Analysis. [2022]As a modification of the duodenal switch (DS), single-anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S) has recently become very popular and is successful for weight loss and T2DM remission. However, current studies have been mostly aimed at patients with severe obesity.
Long-Term Results of Single-Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy (SADI-S). [2022]Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a simplification of the duodenal switch (DS) in which the alimentary limb is eliminated, and the common channel is lengthened from 200 to 300 cm. Short-term results have demonstrated that SADI-S is safe and reproducible and that weight loss and comorbidities resolution are comparable to biliopancreatic diversion or DS.
Direct and two-step single anastomosis duodenal switch (SADI-S): Unicentric comparative analysis of 232 cases. [2021]The "Single Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy" (SADI-S) is a bariatric surgery conceived to simplify the duodenal switch in order to reduce its postoperative complications. The objective of this study is to assess the safety and efficacy of SADI-S, comparing its results in both direct and two-step procedure.
Early Outcomes of Primary SADI-S: an Australian Experience. [2021]Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) surgery is a modification of the traditional duodenal switch (DS) surgery. SADI-S is relatively a new bariatric surgical procedure and has gone by many names depending on the length of the common channel. In this study, we report our initial experience with this novel technique in the Australian population.
The single anastomosis duodenal switch modifications: a review of the current literature on outcomes. [2018]The single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) was designed in 2007 to reduce the side effects of biliopancreatic diversion with duodenal switch (BPD-DS) by replacing the Roux-en-Y construction with a single duodeno-ileal anastomosis and combining the common channel with the alimentary limb. Several variants using different channel lengths were published. The objective of this study was to identify the published cases of SADI-S and variants and assess the results regarding potential benefits on side effects and revisions.
Single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S): experience from a high-bariatric volume center. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">Biliopancreatic diversion with duodenal switch and single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S) are technically demanding hypo-absorptive bariatric procedures generally indicated in super-obese patients (BMI ≥ 50 kg/m2). Data from the literature prove the procedure to be safe and effective, with promising bariatric and metabolic effects. Anyway, international societies support the creation of multicentric national and international registries to obtain more homogeneous data over the long period. We aimed to report our experience with this procedure.
Primary SADI-S in Chinese with Diabetes and BMI < 35 kg/m2: a Retrospective Study with 2-Year Follow-up. [2021]Label="BACKGROUND">Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a bariatric procedure based on the standard duodenal switch surgery. It was first introduced in 2007 as a procedure for individuals with clinically severe obesity. Till date, primary SADI-S has not been used on Chinese with diabetes and body mass index (BMI) < 35 kg/m2.
Evaluation of Metabolic Outcomes Following SADI-S: a Systematic Review and Meta-analysis. [2022]Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) offers a novel bariatric procedure. This systematic review and meta-analysis evaluates observational and comparative studies evaluating SADI-S, with meta-analysis comparing outcomes to other malabsorptive procedures (MPs).