DS vs SIPS-Bariatric Surgery Comparasion

Study Overview
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Brief Summary
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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.

Official Title
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The Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) Results in Less Nutritional Deficiencies Than the Standard Duodenal Switch (DS) Operation: A Multicenter, Randomized Controlled Trial

Conditions
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Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: SIPS Operation
* Procedure: Standard Duodenal Switch Operation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) of 40 to 65 Agree to not use weight loss medications for the length of the study Compliance with standards of surgical program Exclusion Criteria: Patients with a history of previous bariatric surgery except for patients who have had a previous gastric sleeve Previous complex abdominal surgery Poorly controlled medical or psychiatric disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Duodenal Switch (DS)<br> | Procedure: Standard Duodenal Switch Operation<br> <br> |
| Experimental: Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS)<br> | Procedure: SIPS Operation<br>* The SIPS modification of the DS operation entails one less division of the small intestine and one less anastomosis, thereby reducing the time of the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin A Deficiency | Proportion of patients with a vitamin A deficiency | 36 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D, zinc, copper, and albumin | Proportion of patients with vitamin D, zinc, copper, and albumin deficiency | 36 months post surgery | 
| Frequency of stools | Amount of stools per day | 36 months post surgery | 
| Length of Operation | Length of surgical procedure in time | Date of operation | 
| Percentage of excess weight lost | Weight in excess of a body mass index (BMI) of 25.0 lost | 36 months post surgery | 
| Body Mass Index (BMI) | Body mass index (weight in kilograms divided by height in meters squared | 36 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric, duodenal switch, DS, weight loss surgery, SIPS, Single Anastomosis