SIPS Surgery for Obesity

(SIPS Trial)

Overseen By Kayla Diaz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bradley Needleman

Disqualifiers: Pregnancy, Cancer, Barrett's esophagus, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

2 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a surgery called Stomach Intestinal Pylorus Sparing (SIPS) to evaluate its safety and effectiveness for weight loss. It targets individuals considering bariatric surgery for the first time and those who underwent a sleeve gastrectomy but did not achieve sufficient weight loss. Ideal participants may have a BMI over 40 or did not lose half of their excess weight after the initial surgery. The trial aims to assist individuals struggling with obesity by offering a new surgical option. As an unphased trial, it provides an opportunity to explore this innovative approach to weight loss.

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 prior data suggests that the SIPS procedure is safe for bariatric surgery?

Research has shown that the Stomach Intestinal Pylorus-Sparing (SIPS) procedure is safe for treating obesity. Studies have found that it leads to significant weight loss within two years and is a safe choice for patients. Another study confirmed that the SIPS procedure is effective and safe for individuals with severe obesity. Patients who have undergone this treatment have tolerated it well, with no major safety issues reported. For those considering joining a trial, this evidence suggests that SIPS is a well-tolerated option for weight loss surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SIPS procedure for obesity is unique because it preserves the pylorus, the valve that controls food passage from the stomach to the intestine. Unlike traditional bariatric surgeries like gastric bypass or sleeve gastrectomy, which can lead to dumping syndrome due to rapid food movement, SIPS aims to reduce this risk by maintaining a more natural digestive process. Researchers are excited because this approach could lead to fewer side effects and improved nutrient absorption, offering patients a potentially safer and more effective long-term weight management option.

What evidence suggests that the SIPS procedure is effective for obesity?

Research has shown that the Stomach Intestinal Pylorus-Sparing (SIPS) procedure aids in weight loss for individuals with severe obesity. One study found that patients lost significant weight after two years. Another study demonstrated that SIPS is safe and effective in local hospitals. Patients frequently experience weight loss and improvements in health issues such as diabetes. This procedure offers a simpler alternative to more complex surgeries, yielding similar positive outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Bradley Needleman, MD

Principal Investigator

The Ohio State University College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-89 who meet NIH criteria for bariatric surgery or those needing a revision after sleeve gastrectomy because they didn't lose enough weight. Candidates must be able to consent to the procedure and not be pregnant, breastfeeding, planning pregnancy, imprisoned, or have had certain previous surgeries.

Inclusion Criteria

I meet the NIH criteria for weight loss surgery.

I am willing and able to consent to surgery myself.

I had a sleeve gastrectomy over two years ago but didn't lose enough weight or regained some.

Exclusion Criteria

Prisoners

I have or had Barrett's esophagus.

I have had surgery for acid reflux.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Evaluation

Psychological evaluation, dietary counseling, and testing of cardiovascular, pulmonary, and gastrointestinal health, along with blood work to identify or confirm obesity-related comorbid conditions

2-4 weeks

Multiple visits (in-person)

Treatment

Participants undergo the SIPS procedure, a modification to the standard sleeve gastrectomy

1 week

1 visit (in-person, surgical)

Post-operative Care

Ensures adequate pain control and appropriate diet tolerance before hospital discharge while monitoring for potential complications

1-2 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including complication rates and excess weight loss

5 years

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Stomach Intestinal Pylorus-Sparing (SIPS) Procedure

Trial Overview The study tests the SIPS bariatric surgery's safety and effectiveness as both an initial obesity treatment and as a follow-up procedure if prior sleeve gastrectomy failed to achieve significant weight loss.

How Is the Trial Designed?

Group I: Stomach Intestinal Pylorus Sparing (SIPS) Experimental Treatment 1 Intervention

Patients undergoing SIPS procedure as their bariatric surgery of choice.

Stomach Intestinal Pylorus-Sparing (SIPS) Procedure is already approved in United States, European Union, Canada for the following indications:

Approved in United States as SIPS for:

• Obesity
• Weight loss in patients who have not achieved adequate weight loss with sleeve gastrectomy

Approved in European Union as SIPS for:

• Obesity
• Revisional surgery for inadequate weight loss after sleeve gastrectomy

Approved in Canada as SIPS for:

• Obesity
• Weight loss in patients who have not achieved adequate weight loss with sleeve gastrectomy

Who Is Running the Clinical Trial?

Bradley Needleman

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study of 798 patients, the single anastomosis duodenal switch (SIPS) showed fewer long-term complications compared to Roux-en-Y Gastric Bypass (RYGB), including lower rates of reoperations and gastrointestinal issues.

Both procedures resulted in similar weight loss over time, but SIPS had better nutritional outcomes for calcium and vitamin D, along with improved resolution rates for type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of Mid-Term Complications, Weight Loss, and Type 2 Diabetes Resolution of Stomach Intestinal Pylorus-Sparing Surgery (SIPS) Versus Roux-En-Y Gastric Bypass (RYGB) with Three-Year Follow-Up. Cottam, A., Cottam, D., Zaveri, H., et al.[2019]

The stomach intestinal pylorus-sparing (SIPS) procedure shows promising results for weight loss, with patients experiencing an average BMI reduction of 26.6 kg/m2 and 88.7% excess weight loss at the 2-year mark, based on a study of 225 patients.

SIPS surgery demonstrates a favorable safety profile, with a low complication rate; only 2.2% of patients experienced leaks and diarrhea, and there were three surgery-related deaths, indicating that while risks exist, the procedure is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stomach Intestinal Pylorus-Sparing Surgery for Morbid Obesity. Neichoy, BT., Schniederjan, B., Cottam, DR., et al.[2022]

The stomach intestinal pylorus sparing (SIPS) procedure, a modified version of the duodenal switch, showed effective weight loss results with an average BMI reduction of 19 units and a 72% excess weight loss after one year in 123 patients.

The SIPS procedure had a low complication rate, with only 1.6% of patients experiencing diarrhea and 3.2% developing abdominal hematomas, suggesting it may be a safe alternative to traditional bariatric surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stomach Intestinal Pylorus Sparing (SIPS) Surgery for Morbid Obesity: Retrospective Analyses of Our Preliminary Experience. Mitzman, B., Cottam, D., Goriparthi, R., et al.[2022]

In a study of 182 patients comparing biliopancreatic diversion with duodenal switch (BPD-DS) and stomach intestinal pylorus sparing surgery (SIPS), SIPS demonstrated significantly shorter operative times and fewer complications, making it a safer option.

While BPD-DS resulted in slightly greater weight loss over two years, the final body mass index (BMI) was lower in the SIPS group, indicating that SIPS can achieve effective weight management with less surgical risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective comparison of biliopancreatic diversion with duodenal switch with single anastomosis duodenal switch (SIPS-stomach intestinal pylorus sparing surgery) at a single institution with two year follow-up. Surve, A., Zaveri, H., Cottam, D., et al.[2017]

In a study of 185 patients undergoing the SIPS procedure for severe obesity, significant weight loss of 35.6% and a reduction in BMI by 17.8 points were achieved and maintained over 24 months, indicating the procedure's efficacy.

The SIPS procedure demonstrated a low complication rate (0.4%) and led to substantial improvements in obesity-related conditions, with high rates of resolution for GERD (87.1%), type 2 diabetes (93.1%), and hyperlipidemia (87.6%), confirming its safety and effectiveness as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective single-center study evaluating the efficacy of the stomach, intestinal, and pylorus-sparing procedure. Holt, BL., Rice, WV.[2023]

Citations

1. bmiut.com bmiut.com/pdf/single-anastomosis-duodenal-ileal-bypass-with-sleeve-gastrectomy-surgery.pdf

single-anastomosis-duodenal-ileal-bypass-with-sleeve ... Conclusions SADI-S is a safe and effective procedure in both short- and mid-term data points. Diabetes resolution and weight loss appear similar ...

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

Efficacy and safety of single-anastomosis duodeno-ileal ... SADI-S was proposed as a less complex alternative with the potential to achieve greater weight loss than Roux-en-Y gastric bypass (RYGB), a long ...

3. soard.org soard.org/article/S1550-7289(22)00810-3/abstract

A prospective single-center study evaluating the efficacy of ... Patients who underwent the SIPS procedure had meaningful reductions in weight and BMI, and many had resolution of metabolic co-morbidities; ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5779797/

Stomach Intestinal Pylorus-Sparing Surgery for Morbid ... In conclusion, SIPS surgery is a safe procedure with favorable weight loss outcomes at 2 years. Keywords: Morbid obesity, Single anastomosis loop duodenal ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728922008103

A prospective single-center study evaluating the efficacy of ... Our results support that the SIPS procedure is a safe and effective primary treatment for clinically severe obesity in a community-based hospital setting.

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

Single Anastomosis Duodeno-Ileal Bypass with Sleeve ... The Single Anastomosis Duodenal-Ileal Bypass with Sleeve Gastrectomy, referred to as the SADI-S is the most recent procedure to be endorsed by the American ...