Stomach Intestinal Pylorus-Sparing Bariatric Surgery

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of Stomach Intestinal Pylorus Sparing (SIPS) as a primary bariatric surgery. In addition, we will evaluate the safety and efficacy of SIPS performed as a revisional surgery following sleeve gastrectomy (SG) in which adequate weight loss was not achieved.

Detailed Description
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This is a prospective study of an interventional procedure. Results of patients selecting to undergo the Stomach Intestinal Pylorus Sparing (SIPS) procedure will be prospectively collected. In addition to the currently offered bariatric weight loss procedures, patients who present to our bariatric clinic will be presented with information on the SIPS procedure. All patients interested in pursuing bariatric surgery will undergo a standardized bariatric surgery evaluation process as standard of care. Patients interested in undergoing SIPS must meet the following inclusion/exclusion criteria in addition to the established criteria for bariatric surgery. The SIPS procedure will be performed as an investigational procedure. The SIPS procedure involves the creation of a standard sleeve gastrectomy over a 36-40 bougie. Division of the duodenum post-pylorus is performed, followed by the creation of a common channel 300 cm from the ileo-cecal valve. A hand-sewn anti-side duodenoileostomy is performed and the anastomosis tested for leaks through use of endoscopic insufflation and under water air leak test. Incisions are then closed in standard fashion. The SIPS procedure itself is not a separate surgery but rather a modification to the standard of care surgery. All patients electing to enroll in this study will experience the same pre- and postoperative care provided as standard of care to all bariatric surgery patients. A pre-operative evaluation is performed to confirm appropriateness for bariatric surgery and includes: Psychological evaluation, dietary counseling, and testing of cardiovascular, pulmonary, and gastrointestinal health. Pre-operative evaluation also consists of blood work to identify or confirm obesity-related comorbid conditions. Post-operative care provided following bariatric surgery ensures that patients progress with adequate pain control and appropriate diet tolerance before hospital discharge while evaluating and monitoring manifestations of potential complications.

Official Title
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Stomach Intestinal Pylorus Sparing (SIPS) as a Primary and Revisional Bariatric Surgery

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Stomach Intestinal Pylorus-Sparing (SIPS) Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-89 Primary: Satisfies established NIH criteria for bariatric surgery Revision of sleeve gastrectomy: Sleeve gastrectomy performed at least two years prior but the patient did not reach 50% excess weight loss (EWL), has regained 20% of EWL since sleeve gastrectomy, or has current BMI > 40 Willing and able to provide his/her own consent for the surgery Exclusion Criteria: Contraindication to bariatric surgery Current pregnancy/breast feeding or plans for pregnancy Prisoners Previous history of gastrectomy other than sleeve gastrectomy for weight loss History of small bowel resection History of any kind of surgery to treat gastroesophageal reflux disease (GERD) History of or current Barrett's esophagus History of or any kind of cancer diagnosis in last 5 years Large hiatal hernia > 5 cm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stomach Intestinal Pylorus Sparing (SIPS)<br>Patients undergoing SIPS procedure as their bariatric surgery of choice. | Procedure: Stomach Intestinal Pylorus-Sparing (SIPS) Procedure<br>* The SIPS procedure will be performed as an investigational bariatric surgery. The SIPS procedure involves the creation of a standard sleeve gastrectomy over a 36-40 bougie. Division of the duodenum post-pylorus is performed, followed by the creation of a common channel 300 cm from the ileo-cecal valve. A hand-sewn anti-side duodenoileostomy is performed and the anastomosis tested for leaks through use of endoscopic insufflation and under water air leak test. Incisions are then closed in standard fashion. The SIPS procedure itself is not a separate surgery but rather a modification to the standard of care surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as a primary procedure | Complication rates | Short-term (30 days) | 
| Efficacy as a primary procedure | Excess weight loss achieved post-surgery | Long-term (5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss Surgery, Bariatric Surgery