What side effects are associated with this type of intervention?

Common treatments for obesity that alter gastrointestinal anatomy, such as gastric bypass, sleeve gastrectomy, and duodenal switch, can have several side effects. These may include nutritional deficiencies (e.g., vitamin B12, iron, calcium), dumping syndrome (rapid gastric emptying causing nausea, vomiting, diarrhea, and dizziness), surgical complications (e.g., infections, leaks, and blood clots), and gastrointestinal symptoms (e.g., acid reflux, constipation, or diarrhea). Long-term follow-up is essential to manage these potential side effects effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for obesity that alter gastrointestinal anatomy to promote weight loss and improve metabolic outcomes. These include bariatric surgical procedures such as Roux-en-Y gastric bypass, sleeve gastrectomy, and adjustable gastric banding. These surgeries reduce stomach size or reroute the intestines to limit food intake and nutrient absorption. Additionally, the FDA has approved medications like orlistat, which reduces fat absorption, and GLP-1 receptor agonists such as liraglutide and semaglutide, which enhance satiety and reduce appetite. These treatments aim to achieve significant and sustained weight loss in individuals with obesity.

What other types of research exist?

Promising novel alternatives to SIPS for obesity treatment include: 1) Laparoscopic greater curvature plication (LGCP), which reduces gastric volume without implantable devices or gastrectomy, showing improvements in glucose homeostasis and gut hormone secretion. 2) Implantable Gastric Stimulator (IGS), a pacemaker-like device that modulates vagus nerve activity and delays gastric emptying, found to be safe and effective for weight loss. 3) Peroral endoscopic myotomy (POEM), particularly G-POEM, which has shown success in treating severe gastroparesis and may offer benefits for weight management.

← Back to Search

SIPS Surgery for Obesity (SIPS Trial)

N/A

Recruiting

Led By Bradley Needleman, MD

Research Sponsored by Bradley Needleman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary: Satisfies established NIH criteria for bariatric surgery

Willing and able to provide his/her own consent for the surgery

Must not have

History of or current Barrett's esophagus

History of any kind of surgery to treat gastroesophageal reflux disease (GERD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up long-term (5 years)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of SIPS may include typical surgical risks such as infection, bleeding, reaction to anesthesia, nutrient deficiencies due to altered digestion process, and possible need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I meet the NIH criteria for weight loss surgery.

Select...

I am willing and able to consent to surgery myself.

Select...

I am between 18 and 89 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have or had Barrett's esophagus.

Select...

I have had surgery for acid reflux.

Select...

I have had surgery to remove part of my small intestine.

Select...

I have a large hiatal hernia over 5 cm.

Select...

I have had a gastrectomy, but it was not a sleeve gastrectomy for weight loss.

Select...

I cannot have weight loss surgery due to health reasons.

Select...

I have not been diagnosed with any type of cancer in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ long-term (5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~long-term (5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and long-term (5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy as a primary procedure

Safety as a primary procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stomach Intestinal Pylorus Sparing (SIPS)Experimental Treatment1 Intervention

Patients undergoing SIPS procedure as their bariatric surgery of choice.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, such as the Stomach Intestinal Pylorus Sparing (SIPS) procedure, work by altering gastrointestinal anatomy. These procedures reduce the stomach's capacity, change gut hormone levels, and modify nutrient absorption. This leads to early satiety, decreased caloric intake, and improved metabolic outcomes, which are essential for effective weight loss and management of obesity-related health issues.