NCT03236142

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

6.1 years

First QC Date

June 30, 2017

Last Update Submit

August 31, 2018

Conditions

Bariatric Surgery Candidate

Keywords

bariatricduodenal switchDSweight loss surgerySIPSSingle Anastomosis

Outcome Measures

Primary Outcomes (1)

  • Vitamin A Deficiency

    Proportion of patients with a vitamin A deficiency

    36 months post surgery

Secondary Outcomes (5)

  • Vitamin D, zinc, copper, and albumin

    36 months post surgery

  • Frequency of stools

    36 months post surgery

  • Length of Operation

    Date of operation

  • Percentage of excess weight lost

    36 months post surgery

  • Body Mass Index (BMI)

    36 months post surgery

Study Arms (2)

Standard Duodenal Switch (DS)

ACTIVE COMPARATOR
Procedure: Standard Duodenal Switch Operation

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

EXPERIMENTAL
Procedure: SIPS Operation

Interventions

SIPS OperationPROCEDURE

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.

Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS)
Standard Duodenal Switch OperationPROCEDURE
Standard Duodenal Switch (DS)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reading Health Physician Network Weight Management Center

West Reading, Pennsylvania, 19611, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stephan Myers, MD, FACS, Medical Director, Principal Investigator

Study Record Dates

First Submitted

June 30, 2017

First Posted

August 1, 2017

Study Start

January 1, 2017

Primary Completion

January 31, 2023

Study Completion

January 31, 2025

Last Updated

September 5, 2018

Record last verified: 2018-08

Locations

US(1)