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DS vs SIPS-Bariatric Surgery Comparasion

R

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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