DS vs SIPS-Bariatric Surgery Comparasion

Bariatric Surgery Candidate Clinical Trial

Official title:

The Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) Results in Less Nutritional Deficiencies Than the Standard Duodenal Switch (DS) Operation: A Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03236142
• Other study ID #: IRB 016-16
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 31, 2025

Study information

• Verified date: August 2018
• Source: Reading Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Reading Health Physician Network Weight Management Center	West Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Reading Health System

Country where clinical trial is conducted

United States, 

Outcome

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