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DS vs SIPS-Bariatric Surgery Comparasion

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03236142
Enrollment
110
Registered
2017-08-01
Start date
2017-01-31
Completion date
2025-01-31
Last updated
2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate

Keywords

bariatric, duodenal switch, DS, weight loss surgery, SIPS, Single Anastomosis

Brief summary

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.

Interventions

PROCEDURESIPS Operation

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.

PROCEDUREStandard Duodenal Switch Operation

Sponsors

Reading Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Vitamin A Deficiency36 months post surgeryProportion of patients with a vitamin A deficiency

Secondary

MeasureTime frameDescription
Vitamin D, zinc, copper, and albumin36 months post surgeryProportion of patients with vitamin D, zinc, copper, and albumin deficiency
Frequency of stools36 months post surgeryAmount of stools per day
Length of OperationDate of operationLength of surgical procedure in time
Percentage of excess weight lost36 months post surgeryWeight in excess of a body mass index (BMI) of 25.0 lost
Body Mass Index (BMI)36 months post surgeryBody mass index (weight in kilograms divided by height in meters squared

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026