Duodenal Switch vs SIPS for Bariatric Surgery Candidates

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Reading Health System

Must not be taking: Weight loss medications

Disqualifiers: Previous bariatric, Complex abdominal, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of weight loss surgeries to determine which is safer and more effective. The study examines the standard duodenal switch and a newer version called the SIPS operation (Stomach Intestinal Pylorus Sparing Surgery). It targets individuals with a body mass index (BMI) between 40 and 65 who have not undergone previous weight-loss surgeries, except for a gastric sleeve. The goal is to determine if SIPS is a simpler surgery with fewer risks. Participants must agree not to use weight loss medications during the study. As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance surgical options for future patients.

Do I have to stop taking my current medications?

The protocol does not specify if you need to stop taking your current medications, but you must agree not to use weight loss medications during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both SIPS and standard duodenal switch surgeries are generally safe for weight loss. Studies have found that SIPS surgery is safe and effective for individuals with severe obesity, promoting significant weight loss over two years. Patients usually tolerate it well, with few complications.

For the standard duodenal switch, research indicates it effectively promotes significant weight loss and can improve conditions like diabetes. This option is more familiar and has a history of successful long-term results, but it may pose more nutritional risks due to its complexity.

Both surgeries are considered safe, but they differ in complexity and potential risks. Prospective trial participants should consider these factors carefully. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SIPS operation for bariatric surgery candidates because it offers a less invasive alternative to the standard Duodenal Switch (DS) procedure. The SIPS technique involves a single anastomosis, or connection, which simplifies the surgery and potentially reduces recovery time and complications compared to the traditional DS. This unique approach could lead to similar or improved weight loss results with fewer surgical risks, making it an appealing option for those considering bariatric surgery.

What evidence suggests that this trial's treatments could be effective for bariatric surgery candidates?

This trial will compare the effectiveness of SIPS (Single Anastomosis, 300 cm Loop, Duodenal Switch) surgery and standard Duodenal Switch (DS) surgery for weight loss in individuals with severe obesity. Research has shown that both surgeries are effective. Participants in the SIPS arm may experience significant weight loss within two years, with studies indicating it is a safe and effective primary treatment for severe obesity, showing good results at 12 and 24 months. Meanwhile, participants in the standard DS arm may benefit from excellent long-term weight loss and improvement in diabetes, particularly in patients with a high body mass index (BMI). The DS procedure is recognized as one of the most effective weight loss surgeries and for aiding type 2 diabetes, though it may lead to higher rates of nutritional deficiencies. Both surgeries show promising results in helping patients lose significant weight and improve related health conditions. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with a BMI of 40 to 65 who are candidates for bariatric surgery and have not used weight loss medications. Those with prior gastric sleeve surgery may qualify, but those with other past bariatric or complex abdominal surgeries, or uncontrolled medical/psychiatric conditions cannot participate.

Inclusion Criteria

I agree not to take weight loss medications during the study.

You have a very high body weight for your height (BMI between 40 and 65).

Compliance with standards of surgical program

Exclusion Criteria

I have a medical or mental health condition that is not well-managed.

I have had bariatric surgery, but it was not a gastric sleeve.

I have had complex surgery in my abdomen before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either the standard duodenal switch (DS) or the single anastomosis, 300 cm loop, duodenal switch (SIPS) procedure

Date of operation

Follow-up

Participants are monitored for nutritional deficiencies and weight loss outcomes

36 months

What Are the Treatments Tested in This Trial?

Interventions

• SIPS Operation
• Standard Duodenal Switch Operation

Trial Overview The study compares two types of bariatric surgery: the standard Duodenal Switch (DS) and the Single Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy (SIPS). It aims to determine if SIPS is as effective and safer than DS, with fewer nutritional/surgical risks.

How Is the Trial Designed?

Group I: Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) Experimental Treatment 1 Intervention

Group II: Standard Duodenal Switch (DS) Active Control 1 Intervention

SIPS Operation is already approved in United States, European Union for the following indications:

Approved in United States as SIPS for:

• Obesity
• Type 2 Diabetes

Approved in European Union as SIPS for:

• Obesity
• Metabolic Disorders

Who Is Running the Clinical Trial?

Reading Health System

Lead Sponsor

Trials

1

Recruited

110+

Published Research Related to This Trial

In a study of 69 patients with non-resectable duodenal ulcers, troncular vagotomy with antrectomy and Finsterer exclusion (VTAF) was found to be the preferred surgical method, showing no recurrence of ulcers after over a year of follow-up in 70.5% of patients.

Troncular vagotomy and gastrojejunostomy (VTGE) had a higher recurrence rate of 16.6% and a higher mortality rate, suggesting that VTAF is a safer and more effective option for patients with difficult duodenum conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Immediate and late results of surgical alternatives in the treatment of non-resectable duodenal ulcers (author's transl)]. Chacon, JP., Figueira, A.[2006]

In a study of 106 patients with severe dumping syndrome following gastric resection, various surgical interventions were performed, including Billroth-I reconstruction and a novel method involving interposition of a long iliac segment.

The outcomes of these surgical techniques were reported, indicating potential effectiveness in managing dumping syndrome, although specific results and comparisons among the methods were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment of the Dumping-syndrome (author's transl)]. Schalimov, AA., Sajenko, WF.[2006]

In a study of 42 pediatric patients undergoing arterial switch operations, those with Taussig-Bing anomaly had a higher incidence of aortic arch and coronary anomalies compared to those with transposition of the great arteries, but early and mid-term outcomes were similar for both groups.

The early mortality rate was 13.3% for Taussig-Bing anomaly patients and 7.4% for those with transposition of the great arteries, indicating that while there are risks associated with Taussig-Bing anomaly, the arterial switch operation can be performed successfully for both conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of arterial switch operation for Taussig-Bing anomaly versus transposition of great arteries and ventricular septal defect. Erek, E., Suzan, D., Aydın, S., 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]

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]

A study comparing 185 patients who underwent either single-anastomosis duodenal-ileal bypass (SADI-S) or double-anastomosis duodenal switch (DS) found that both procedures resulted in similar weight loss outcomes over 24 months, with SADI-S showing a total weight loss of 44.2% compared to 48.4% for double-anastomosis DS.

Both procedures had comparable complication rates, but a significant number of patients (40% to 60%) experienced low vitamin D levels post-surgery, highlighting the need for close nutritional follow-up after either type of bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of single- versus double-anastomosis duodenal switch at a single institution. Moon, RC., Kirkpatrick, V., Gaskins, L., et al.[2020]

In a study of 125 patients with a mean BMI of 50, the duodenal switch (DS) procedure resulted in over 70% excess weight loss after 1 year and 81.4% after 5 years, with 97% of patients achieving more than 50% excess weight loss.

All patients experienced improvements or cures of their obesity-related comorbidities, demonstrating the effectiveness of DS in treating morbid obesity, particularly in super obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duodenal switch: an effective therapy for morbid obesity--intermediate results. Baltasar, A., Bou, R., Bengochea, M., et al.[2007]

Patients who underwent single anastomosis duodenal switch (LDS) experienced significantly greater weight loss compared to those who had vertical sleeve gastrectomy (VSG), with a 29% difference in total weight loss percentage (TWL) at 18 months post-surgery.

The study suggests that the intestinal component of the LDS procedure plays a crucial role in long-term weight loss, as the difference in weight loss between LDS and VSG patients increased over time, highlighting the importance of intestinal length preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Matched Cohort Analysis of Sleeve Gastrectomy With and Without 300 cm Loop Duodenal Switch With 18-Month Follow-Up. Cottam, A., Cottam, D., Roslin, M., 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]

A retrospective analysis comparing the stomach intestinal pylorus sparing (SIPS) surgery to biliopancreatic diversion with duodenal switch (BPDDS) showed no significant difference in weight loss or nutritional outcomes over 2 years, indicating that SIPS is as effective as BPDDS.

SIPS surgery demonstrated lower complication rates compared to BPDDS, suggesting it may be a safer option, although the small sample size means these findings are not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Matched Cohort Analysis of Stomach Intestinal Pylorus Saving (SIPS) Surgery Versus Biliopancreatic Diversion with Duodenal Switch with Two-Year Follow-up. Cottam, A., Cottam, D., Portenier, D., et al.[2022]

In a study of 460 patients undergoing either biliopancreatic diversion with duodenal switch (BPD-DS) or single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), BPD-DS resulted in greater total body weight loss (TBWL) at 2 years, but both procedures had similar overall complication rates (14% for BPD-DS vs 18% for SADI-S).

SADI-S had a shorter operative time compared to BPD-DS (140.85 minutes vs 167.25 minutes), but it also led to more emergency department visits (17% vs 7%), indicating a potential trade-off between quicker surgery and post-operative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single- Versus Double-Anastomosis Duodenal Switch: Outcomes Stratified by Preoperative BMI. Lind, RP., Ghanem, M., Teixeira, AF., et al.[2022]

The arterial switch operation combined with ventricular septal defect closure (ASO+VSDc) for treating Taussig-Bing anomaly showed an acceptable survival rate of 88% at 10 years, indicating its efficacy as a surgical intervention.

Complex coronary anatomy was identified as a significant risk factor for early mortality, but other anatomical factors did not affect survival outcomes, suggesting that ASO+VSDc is a reliable option for most patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arterial switch operation in patients with Taussig-Bing anomaly--influence of staged repair and coronary anatomy on outcome. Griselli, M., McGuirk, SP., Ko, CS., et al.[2019]

Citations

1. 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 ...

2. 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.

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

A prospective single-center study evaluating the efficacy of ... This single-site prospective study of patients who underwent the SIPS procedure evaluated outcomes at 12 and 24 months. Mean changes in total ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29398898/

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

5. link.springer.com link.springer.com/article/10.1007/s11695-019-04352-y

Single Anastomosis Duodenal Switch: 1-Year Outcomes SADS is a highly efficacious weight loss procedure with significant comorbidity reduction at 1 year. At 1 year, complications and vitamin and mineral deficits ...

6. soard.org soard.org/article/S1550-7289(20)30149-0/fulltext

American Society for Metabolic and Bariatric ... Stomach intestinal pylorus-sparing surgery for morbid obesity ... Mid-term outcomes of gastric bypass weight loss failure to duodenal switch.

7. old.asmbs.org old.asmbs.org/app/uploads/2020/11/PIIS1550728920301490.pdf

American Society for Metabolic and Bariatric Surgery updated ... The single-anastomosis duodenal switch, also known as the loop duodenal switch, stomach intestinal pylorus- sparing surgery, and most descriptively single- ...