SIPS Surgery for Obesity
(SIPS Trial)
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.12345
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.12345
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.12345
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Treatment
Participants undergo the SIPS procedure, a modification to the standard sleeve gastrectomy
Post-operative Care
Ensures adequate pain control and appropriate diet tolerance before hospital discharge while monitoring for potential complications
Follow-up
Participants are monitored for safety and effectiveness after treatment, including complication rates and excess weight loss
Treatment Details
Interventions
- Stomach Intestinal Pylorus-Sparing (SIPS) Procedure (Procedure)
Stomach Intestinal Pylorus-Sparing (SIPS) Procedure is already approved in Canada for the following indications:
- Obesity
- Weight loss in patients who have not achieved adequate weight loss with sleeve gastrectomy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bradley Needleman
Lead Sponsor