Recruiting

DS vs. SIPS

Sponsor:

Reading Health System

Code:

NCT03236142

Conditions

Bariatric Surgery Candidate

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Accepted

Interventions

SIPS Operation

Standard Duodenal Switch Operation

Study Details

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.

Conditions

Bariatric Surgery Candidate

Study ID

NCT03236142

Start date

Jan, 2017

Status verified date

Aug, 2018

Completion date

Jan 31, 2025

Anticipated

Primary completion date

Jan 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Standard Duodenal Switch (DS)

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

Interventions

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.

Standard Duodenal Switch Operation

Primary outcome measure

  • Vitamin A Deficiency [ Time Frame: 36 months post surgery ]

Central Contacts and Locations

Locations

Reading Health Physician Network Weight Management Center

Recruiting

West Reading, Pennsylvania, United States, 19611

Contacts

Malissa Sullivan Bariatric Coordinator

484-628-3141Malissa.Sullivan@towerhealth.org

Stephan Myers Principal Investigator

484-628-3064stephan.myers@towerhealth.org

Principal Investigator:

Stephan Myers, MD

More Information

Sponsor

Reading Health System

Last update posted

Sep 5, 2018

Last verified

Aug, 2018

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Reading Health System on 2018-09-05.