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

Trial Summary

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the SIPS procedure, a modified weight-loss surgery. It targets patients needing bariatric surgery, including those who didn't lose enough weight from a previous surgery. The procedure helps patients feel full with less food and absorb fewer calories, promoting 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 data supports the effectiveness of the SIPS treatment for obesity?

The SIPS treatment, a variation of the duodenal switch surgery, has shown similar weight loss results to the traditional Roux-en-Y Gastric Bypass (RYGB) but with fewer complications and better outcomes for type 2 diabetes. It is designed to be a simpler and potentially safer option while maintaining effective weight loss and reducing the risk of long-term complications. ^{1 2 3 4 5}

Is the SIPS surgery generally safe for humans?

The SIPS surgery, also known as the Stomach Intestinal Pylorus-Sparing procedure, is considered a simpler and potentially safer variation of the traditional duodenal switch surgery. Studies suggest it may have fewer complications compared to other weight loss surgeries like the Roux-en-Y Gastric Bypass, with similar weight loss results. ^{1 2 3 4 5}

How is the SIPS treatment different from other obesity treatments?

The SIPS treatment is unique because it combines a sleeve gastrectomy (removal of part of the stomach) with a single connection between the stomach and the small intestine, which is simpler and potentially safer than traditional methods. It aims to provide similar weight loss benefits as other surgeries like the Roux-en-Y but with fewer complications such as diarrhea and malnutrition. ^{1 2 3 4 5}

Research Team

Bradley Needleman, MD

Principal Investigator

The Ohio State University College of Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

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

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

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

Stomach Intestinal Pylorus-Sparing Surgery for Morbid Obesity. [2022]

3. United States 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. [2017]

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

Stomach Intestinal Pylorus Sparing (SIPS) Surgery for Morbid Obesity: Retrospective Analyses of Our Preliminary Experience. [2022]

5. United States 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. [2019]