Single Anastomosis Duodenal Ileal Bypass (SADI) for Sleeve Revision

NCT04165694 | Active Not Recruiting

• 1 other identifier: 12208
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is two part: 1) to add to the literature which is still somewhat sparse with numbers of patients undergoing the Single Anastomosis Duodenal Ileal Bypass (SADI) as a revision for laparoscopic sleeve gastrectomy (LSG) and 2) to have a treatment option for our Kaiser Permanente patients who seek additional assistance after a LSG with persistent morbid obesity and the comorbidities that come with it.

Conditions

Bariatric Surgery Candidate; Severe Obesity

Keywords

weight loss failure; laparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

• Percent Total Weight Loss (change in weight relative to baseline)

  This is weight loss relative to the initial body weight at the time of surgery calculated as (weight at surgery - weight at follow-up)/weight at surgery. This is already a change score.

  3 years

Interventions

Single Anastomosis Duodenal Ileal Bypass (SADI) PROCEDURE

The purpose of the research is to study additional weight loss and resolution of comorbidities in patients who undergo revision of their sleeve gastrectomy to a Single Anastomosis Duodenal Ileal bypass (SADI). The sleeve gastrectomy which you have already undergone is now the most common bariatric procedure performed. This operation was part of a 2-stage operation known a Duodenal Switch (DS) which was a sleeve gastrectomy followed by a long bypass of the intestine that involved 2 connections. This operation has many complications such as vitamin deficiencies and potential malnutrition. The SADI procedure is a version of the DS that bypasses less of the intestine and one less connection of the small bowel.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) 35 - 39 kg/m2 with comorbid conditions; OR
• BMI 40+ kg/m2 with no comorbidities; AND
• having a previous laparoscopic sleeve gastrectomy (LGS); AND
• having lost less than 10% total weight loss with this LSG; AND
• being a Kaiser member at the time of surgery; AND
• being at least 18 years of age.

You may not qualify if:

• BMI less than 35 kg/m2; OR
• having a hiatal hernia; OR
• having severe Gastroesophageal Reflux Disease; OR
• having a primary bariatric procedure other than LSG; OR
• having already had a revisional bariatric procedure; OR
• being less than 18 years old.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Southern California West Los Angeles Medical Center

Los Angeles, California, 90034, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a pre-/post-test prospective intervention.

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 18, 2019
• Study Start: October 15, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)