SADI Surgery Revision for Obesity

(SADI Trial)

Overseen By Robert Casillas, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Hiatal hernia, Severe GERD, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a surgical option for individuals who have undergone gastric sleeve surgery but continue to struggle with severe obesity. It examines the Single Anastomosis Duodenal Ileal Bypass (SADI) as a follow-up procedure. The trial targets those who lost less than 10% of their weight after the initial surgery and face obesity-related health issues. Individuals who had a gastric sleeve, are Kaiser members, and have a BMI of 35 or higher with specific conditions may qualify. As an unphased trial, it offers participants the chance to contribute to innovative surgical solutions for obesity.

Do I need to stop my current medications for the trial?

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 prior data suggests that the SADI surgery revision is safe for patients with persistent morbid obesity?

Research has shown that Laparoscopic Sleeve Gastrectomy (LSG) is generally safe, with fewer complications and less need for additional surgery up to five years post-procedure. One study found that only 15% of patients experienced complications, with no deaths reported.

Single Anastomosis Duodenal Ileal Bypass (SADI) has been found to be safe and effective, particularly for those requiring further surgery after procedures like LSG. Initially, SADI had more complications than other surgeries, though its short-term results are similar to other complex procedures.

In summary, both LSG and SADI are considered safe for many patients, but SADI might have a slightly higher chance of early complications. Always consult a healthcare provider to determine if these options are suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Laparoscopic Sleeve Gastrectomy (LSG) for treating obesity because it offers a less invasive approach compared to traditional bariatric surgeries like gastric bypass. LSG involves removing a portion of the stomach, which not only limits food intake but also reduces hunger by decreasing the production of hunger-inducing hormones. This procedure typically involves fewer complications and a quicker recovery time, making it an attractive alternative for patients seeking effective weight loss solutions.

What evidence suggests that the SADI surgery is effective for obesity?

Research shows that Laparoscopic Sleeve Gastrectomy (LSG) effectively aids weight loss and improves obesity-related health issues. Studies indicate that both LSG and Roux-en-Y Gastric Bypass result in significant and lasting weight loss for up to 10 years. However, some individuals may regain weight after about two years and might require additional surgery.

For those needing further treatment, the Single Anastomosis Duodenal Ileal Bypass (SADI), studied in this trial, has demonstrated excellent results. Observational data suggest that SADI can reduce excess weight by 67% to 114% within two years. SADI also appears more effective than other procedures for weight loss, with a similar level of safety. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults who are Kaiser Permanente members, have a BMI of 40+ without other health issues or a BMI of 35-39 with comorbidities, and have had less than 10% weight loss after a laparoscopic sleeve gastrectomy. It's not for those under 18, with severe GERD, hiatal hernia, previous bariatric revisions other than LSG, or a primary bariatric procedure different from LSG.

Inclusion Criteria

My BMI is 40 or more and I have no other health conditions.

I have lost less than 10% of my total weight with this surgery.

I have had a laparoscopic sleeve gastrectomy.

Exclusion Criteria

I have had a second weight loss surgery.

I had a different weight loss surgery, not the sleeve gastrectomy.

I have a hiatal hernia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Surgery Preparation

Surgical consult and preparation visits before the SADI procedure

2-6 weeks

2 visits (in-person)

Surgery and Immediate Post-Surgery

SADI procedure and immediate post-surgery follow-up

1-2 weeks

1 visit (in-person)

Post-Surgery Follow-up

Follow-up visits to monitor recovery and initial outcomes

6 months

3 visits (in-person)

Long-term Follow-up

Annual follow-up to monitor weight loss and complications

3 years

Annual phone calls

What Are the Treatments Tested in This Trial?

Interventions

• Laparoscopic Sleeve Gastrectomy (LSG)
• Single Anastomosis Duodenal Ileal Bypass (SADI)

Trial Overview The study tests the Single Anastomosis Duodenal Ileal Bypass (SADI) as an additional treatment for patients who didn't lose enough weight following their initial laparoscopic sleeve gastrectomy. The aim is to provide another option for significant weight loss and improvement in obesity-related conditions.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37606806/

Long-Term Outcome of Laparoscopic Sleeve Gastrectomy ... This study aimed to present our long-term laparoscopic sleeve gastrectomy (LSG) efficacy in terms of weight loss and obesity-related complications resolution.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6528116/

Long-term outcomes of laparoscopic sleeve gastrectomy Long-term follow-up reveals a tendency to weight regain after approximately 2 years from primary surgery, with the need for revisional surgery in some cases.

3. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2017/03000/laparoscopic_sleeve_gastrectomy_versus.8.aspx

Laparoscopic Sleeve Gastrectomy Versus Roux-Y-Gastric.. ... In this trial, LSG and LRYGB are equally efficient regarding weight loss, quality of life, and complications up to 3 years postsurgery.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1015958424012697

Comparing long-term outcomes between laparoscopic ... The aim of this study is to compare the degree of long-term weight loss, remission of co-morbidities and complication rates following LRYGB and LSG procedures.

5. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2793539

Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y ... In this 10-year follow-up of a randomized clinical trial including 240 patients, both LSG and LRYGB resulted in good and sustainable weight loss.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10603075/

Long-Term Results of Laparoscopic Sleeve Gastrectomy The estimated weight regain was 28%, and the estimated overall revision rate was 20%, being weight regain the main cause for reintervention.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12411146/

Laparoscopic Sleeve Gastrectomy: Efficacy and Safety of ... At 12 months, 70.7% of Hard LSG patients achieved a normal BMI (<25 kg/m2), compared to 42.2% in the Classic group. At 3 years, 59.3% and 20.4% maintained ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728924001722

Safety of redo sleeve gastrectomy as a primary revisional ... RSG is a safe procedure relative to overall rates of complications associated with revisional bariatric surgery in the short term.

9. nature.com nature.com/articles/s41598-024-52817-7

The outcomes of Re-Redo bariatric surgery—results from ... The mean BMI after treatment was 31.9 ± 5.3 kg/m2. Complications occurred in 3 of 20 patients (15%), with no reported mortality or need for ...

10. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2784823

Safety of Sleeve Gastrectomy and Gastric Bypass After ... Sleeve gastrectomy was associated with a lower risk of mortality, complications, and overall reintervention 5 years after surgery.