DS vs SIPS-Bariatric Surgery Comparasion

August 31, 2018 updated by: Stephan Myers, MD, Reading Health System

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Health Physician Network Weight Management Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephan Myers, MD
        • Sub-Investigator:
          • Leon Katz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Duodenal Switch (DS)
Procedure: Standard Duodenal Switch Operation
Experimental: Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS)
Procedure: SIPS 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reading Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

January 31, 2025

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

July 28, 2017

First Posted (Actual)

August 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

August 31, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB 016-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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