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

54 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Laparoscopic Sleeve Gastrectomy (LSG) and Single Anastomosis Duodenal Ileal Bypass (SADI) for obesity?

Research shows that the combination of Laparoscopic Sleeve Gastrectomy (LSG) and Single Anastomosis Duodenal Ileal Bypass (SADI) can lead to significant weight loss, with total weight loss ranging from 20.5% to 46.2%. This treatment is considered effective for patients who have not achieved desired results with LSG alone, and it has an acceptable rate of complications. ^{1 2 3 4 5}

Is SADI surgery safe for humans?

The SADI surgery, often used after a sleeve gastrectomy, has been studied in 398 patients and found to have early complications in 4.1% of cases, with no deaths reported. This suggests that the surgery is generally safe, with acceptable levels of complications. ^{1 2 3 6 7}

How does the SADI surgery revision for obesity differ from other treatments?

The SADI surgery revision for obesity is unique because it combines a single-anastomosis duodeno-ileal bypass with a sleeve gastrectomy, specifically targeting patients who have experienced weight regain after an initial sleeve gastrectomy. This approach is distinct from other treatments as it offers a revisional option with satisfactory weight loss results and acceptable complication rates. ^{1 2 3 8 9}

What is the purpose of this trial?

The goal of this study is two part: 1) to add to the literature which is still somewhat sparse with numbers of patients undergoing the Single Anastomosis Duodenal Ileal Bypass (SADI) as a revision for laparoscopic sleeve gastrectomy (LSG) and 2) to have a treatment option for our Kaiser Permanente patients who seek additional assistance after a LSG with persistent morbid obesity and the comorbidities that come with it.

Eligibility Criteria

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

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

Treatment Details

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+

References

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

Short- to medium-term results of single-anastomosis duodeno-ileal bypass compared with one-anastomosis gastric bypass for weight recidivism after laparoscopic sleeve gastrectomy. [2021]

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

Single Anastomosis Duodeno-ileostomy (SADI-S) Versus One Anastomosis Gastric Bypass (OAGB-MGB) as Revisional Procedures for Patients with Weight Recidivism After Sleeve Gastrectomy: a Comparative Analysis of Efficacy and Outcomes. [2021]

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

Single Anastomosis Duodeno-ileal Bypass As a Revisional Procedure Following Sleeve Gastrectomy: Review of the Literature. [2021]

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

Sleeve gastrectomy as revisional procedure for failed gastric banding or gastroplasty. [2010]

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

Revisional bariatric surgery following failed primary laparoscopic sleeve gastrectomy: a systematic review. [2021]

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

Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) as a revisional surgery. [2019]

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

A Multimodal Analgesic Protocol Reduces Opioid-Related Adverse Events and Improves Patient Outcomes in Laparoscopic Sleeve Gastrectomy. [2018]

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

Efficacy and Drawbacks of Single-Anastomosis Duodeno-Ileal Bypass After Sleeve Gastrectomy in a Tertiary Referral Bariatric Center. [2021]

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

Revisional Laparoscopic SADI-S vs. Duodenal Switch Following Failed Primary Sleeve Gastrectomy: a Single-Center Comparison of 101 Consecutive Cases. [2021]