DS vs SIPS-Bariatric Surgery Comparasion

Reading Health System

Status: Enrolling

Conditions: Bariatric Surgery Candidate

Treatments: Procedure: Standard Duodenal Switch Operation; Procedure: SIPS Operation

Study type: Interventional

Funder types: Other

Identifiers

NCT03236142

IRB 016-16

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Standard Duodenal Switch (DS)

Active Comparator group

Treatment:

Procedure: Standard Duodenal Switch Operation

Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS)

Experimental group

Treatment:

Procedure: SIPS Operation