DS vs SIPS-Bariatric Surgery Comparasion

NCT ID: NCT03236142

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Standard Duodenal Switch (DS)

Group Type ACTIVE_COMPARATOR

Standard Duodenal Switch Operation

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

SIPS Operation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Standard Duodenal Switch Operation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Reading Health System

OTHER

Sponsor Role lead

Responsible Party

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Stephan Myers, MD

Stephan Myers, MD, FACS, Medical Director, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Reading Health Physician Network Weight Management Center

West Reading, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Malissa Sullivan Bariatric Coordinator

Role: primary

484-628-3141

Stephan Myers Principal Investigator

Role: backup

484-628-3064

Other Identifiers

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IRB 016-16

Identifier Type: -

Identifier Source: org_study_id

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