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

110 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to answer the question of whether the single anastomosis, 300 cm loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less nutritional and surgical risks than the standard duodenal switch (DS) operation. Please note, this study does not provide a stipend or coverage for surgery.

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.

What data supports the idea that Duodenal Switch vs SIPS for Bariatric Surgery Candidates is an effective treatment?

The available research shows that both the traditional Duodenal Switch and the newer SIPS procedure are effective treatments for weight loss in bariatric surgery candidates. The traditional Duodenal Switch is known for its long-term weight loss success and reduction of related health issues. However, it can have complications like diarrhea and malnutrition. The SIPS procedure was developed to simplify the surgery and reduce these complications while still achieving similar weight loss results. Studies indicate that SIPS offers comparable outcomes to the traditional Duodenal Switch, with potentially fewer side effects, making it an effective alternative treatment. ^{1 2 3 4 5}

What safety data exists for Duodenal Switch and SIPS bariatric surgeries?

The relevant study titled 'A Matched Cohort Analysis of Sleeve Gastrectomy With and Without 300 cm Loop Duodenal Switch With 18-Month Follow-Up' provides insights into the safety and outcomes of the Single Anastomosis Duodenal Switch (LDS), which is a variant of the Duodenal Switch procedure. This study compares patients who underwent a Vertical Sleeve Gastrectomy (VSG) with those who had the LDS, helping to evaluate the safety and effectiveness of the LDS procedure over an 18-month period. However, the study primarily focuses on weight loss outcomes rather than detailed safety data. ^{6 7 8 9 10}

Is the SIPS treatment a promising option for bariatric surgery candidates?

Yes, the SIPS treatment is promising because it is a simpler and potentially safer version of the traditional duodenal switch surgery. It offers similar weight loss results with fewer complications, making it an attractive option for those needing bariatric surgery. ^{1 2 4 11 12}

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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]

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]

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]

References

1. 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]

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

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

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

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

4. United States 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. [2022]

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

Single- Versus Double-Anastomosis Duodenal Switch: Outcomes Stratified by Preoperative BMI. [2022]

6. United States 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. [2022]

7. Turkey pubmed.ncbi.nlm.nih.gov

Outcomes of arterial switch operation for Taussig-Bing anomaly versus transposition of great arteries and ventricular septal defect. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Surgical treatment of the Dumping-syndrome (author's transl)]. [2006]

9. Brazil pubmed.ncbi.nlm.nih.gov

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

10. Germany pubmed.ncbi.nlm.nih.gov

Arterial switch operation in patients with Taussig-Bing anomaly--influence of staged repair and coronary anatomy on outcome. [2019]

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

Safety and effectiveness of single- versus double-anastomosis duodenal switch at a single institution. [2020]

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

Duodenal switch: an effective therapy for morbid obesity--intermediate results. [2007]