DS vs SIPS-Bariatric Surgery Comparasion

Not Applicable

Recruiting

• Conditions: Bariatric Surgery Candidate
• Interventions: Procedure: Standard Duodenal Switch Operation; Procedure: SIPS Operation

• Registration Number: NCT03236142
• Lead Sponsor: Reading Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-31
• Last Update Posted: 2018-09-05
• Primary Completion: 2023-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Duodenal Switch (DS)	Standard Duodenal Switch Operation	-
Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS)	SIPS Operation	-

Primary Outcome Measures

Name	Time	Method
Vitamin A Deficiency	36 months post surgery	Proportion of patients with a vitamin A deficiency

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Reading Health Physician Network Weight Management Center; 🇺🇸 West Reading, Pennsylvania, United States