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.
Is the SIPS treatment a promising option for obesity?Yes, the SIPS treatment is promising for obesity. It offers similar weight loss to other surgeries like the Roux-en-Y Gastric Bypass but with fewer complications. It is also simpler and potentially safer than traditional methods, and it helps with diabetes resolution.12345
What safety data is available for the SIPS surgery for obesity?The SIPS procedure, also known as the Stomach Intestinal Pylorus-Sparing Surgery, has been evaluated in several studies. It is a variation of the duodenal switch designed to be simpler and potentially safer. Studies have compared SIPS to traditional procedures like the biliopancreatic diversion with duodenal switch (BPD-DS) and Roux-en-Y Gastric Bypass (RYGB). Findings suggest that SIPS may offer similar weight loss with fewer complications, such as diarrhea, malnutrition, ulcers, and internal hernias, and better diabetes resolution. However, more research is needed to substantiate mid-term complication and nutritional differences.12345
What data supports the idea that SIPS Surgery for Obesity is an effective treatment?The available research shows that SIPS Surgery for Obesity is effective because it offers similar weight loss to other procedures like the Roux-en-Y Gastric Bypass (RYGB) and the traditional duodenal switch, but with fewer complications. For example, one study found that SIPS provides the same weight loss as the RYGB while also improving diabetes outcomes. Another study highlighted that SIPS is a simpler and potentially safer variation of the duodenal switch, which is known for long-term weight loss success. Overall, SIPS seems to balance effective weight loss with a lower risk of complications compared to other treatments.12345
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
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 am between 18 and 89 years old.
Exclusion Criteria
I have or had Barrett's esophagus.
I have had surgery for acid reflux.
I have had surgery to remove part of my small intestine.
I have a large hiatal hernia over 5 cm.
I have had a gastrectomy, but it was not a sleeve gastrectomy for weight loss.
I cannot have weight loss surgery due to health reasons.
I have not been diagnosed with any type of cancer in the last 5 years.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: Stomach Intestinal Pylorus Sparing (SIPS)Experimental Treatment1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
The Ohio State University Wexner Medical CenterColumbus, OH
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Who is running the clinical trial?
Bradley NeedlemanLead Sponsor
References
Stomach Intestinal Pylorus Sparing (SIPS) Surgery for Morbid Obesity: Retrospective Analyses of Our Preliminary Experience. [2022]Although the duodenal switch (DS) has been the most effective weight loss surgical procedure, it is a small minority of the total bariatric surgical cases performed. Modifications that can make the operation technically simpler and reduce a long-term risk of short bowel syndrome would be of benefit. The aim of this study was to detail our initial experience with a modified DS called stomach intestinal pylorus sparing (SIPS) procedure.
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]The traditional duodenal switch is performed using a Roux-en-Y configuration. This procedure has proven to be the most effective procedure for long-term weight loss and co-morbidity reduction. Recently, stomach intestinal pylorus sparing surgery (SIPS) has been introduced as a simpler and potentially safer variation of the duodenal switch (DS). It is a single anastomosis end-to-side proximal duodeno-ileal bypass with a sleeve gastrectomy. In this study, we compare our outcomes between biliopancreatic diversion with duodenal switch (BPD-DS) and SIPS at 2 years.
Stomach Intestinal Pylorus-Sparing Surgery for Morbid Obesity. [2022]The Roux-en-Y duodenal switch (RYDS) is one of the most efficient forms of bariatric surgery. However, diarrhea, malnutrition, ulcers, and internal hernias have hampered its widespread adoption. The stomach intestinal pylorus-sparing (SIPS) procedure was developed to alleviate these sequelae while retaining the same weight loss as the RYDS. In this study, we report our midterm experience with this novel technique.
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]For many years, the Roux-en-Y Gastric Bypass (RYGB) was considered a good balance of complications and weight loss. According to several short-term studies, single anastomosis duodenal switch or stomach intestinal pylorus sparing surgery (SIPS) offers similar weight loss to RYGB with fewer complications and better diabetes resolution. No one has substantiated mid-term complication and nutritional differences between these two procedures. This paper seeks to compare complication and nutritional outcomes between RYGB and SIPS.
A prospective single-center study evaluating the efficacy of the stomach, intestinal, and pylorus-sparing procedure. [2023]The stomach, intestinal, and pylorus-sparing (SIPS) procedure is a single-anastomosis duodeno-intestinal bypass used in obesity management.