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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Duodenal Switch (DS) | Active Comparator |
| |
| Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIPS Operation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin A Deficiency | Proportion of patients with a vitamin A deficiency | 36 months post surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reading Health Physician Network Weight Management Center | Recruiting | West Reading | Pennsylvania | 19611 | United States |
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| Standard Duodenal Switch Operation | Procedure |
|
| 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 |