- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04165694
Single Anastomosis Duodenal Ileal Bypass (SADI) for Sleeve Revision (SADI)
Single Anastomosis Duodenal Ileal Bypass (SADI) as a Second Stage for Sleeve Gastrectomy Weight Loss Failure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will be recruited during 10/15/2019 through 12/31/2022 with the following inclusion criteria: 1) body mass index (BMI) 35 - 39 kg/m2 with comorbid conditions; 2) BMI 40+ kg/m2 with no comorbidities; 3) having a previous LGS; 4) having lost less than 10% total weight loss with this LSG; 5) being a Kaiser member at the time of surgery; and 6) being at least 18 years of age. Exclusion criteria will include: 1) BMI less than 35; 2) having a hiatal hernia; 3) having severe Gastroesophageal Reflux Disease; 4) having a primary bariatric procedure other than LSG; 5) having already had a revisional bariatric procedure; and 6) being less than 18 years old.
Age range for participants will be 18 - 100 years old. We will recruit 50 patients.
Revisional procedures for weight regain are PART OF USUAL CARE at Kaiser Permanente Southern California. However SADI is a type of revisional procedure that is still considered experimental. This procedure has a single surgical anastomosis. It has a restrictive component when reducing the greater curvature of the stomach, but specially a malabsorptive component, as the common channel is also reduced. The objective of this surgical technique is to lessen the intestinal loop where nutrients are absorbed. It was part of a more extreme procedure, that is currently standard of care, called the Duodenal Switch (DS).
The DS procedure which is PART OF USUAL CARE results in very successful massive weight loss however, it also has severe complications especially vitamin deficiencies.
The SADI procedure is thought to confer the same weight loss benefits of the DS but without the severe complications. This has not been tested systematically.
These eligibility criteria will be verified by the bariatric surgeon who is doing the consult for a revisional procedure AS PART OF USUAL CARE. This will entail the surgeon looking in the electronic medical record before meeting with the patient.
However, this review of the medical record before surgical consult is PART OF USUAL CARE.
All data collection and study follow-up visits are PART OF USUAL CARE for bariatric patients at Kaiser Permanente Southern California. THIS INCLUDES PATIENTS WHO RECEIVE REVISIONAL SURGERY. The only part of the study that is not usual care is the surgical procedure itself. The patients enrolled in the proposed study will receive the following visits AS PART OF USUAL CARE:
- Surgical consult 2 - 6 weeks before surgery at which point the patients will be offered the SADI procedure and consent will be done by the surgeon doing the consult in person in the surgeon's office in the Department of Surgery at the West Los Angeles Medical Center.
- Visit with bariatric physician 7 - 10 days before surgery to go over laboratory values and to insure instructions for surgical preparation were followed.
- Visit with surgeon and bariatric physician 7 - 10 days after surgery.
- Visit with bariatric physician 4 - 6 weeks after surgery.
- Visit 6 months after surgery with surgeon, bariatric physician, and other te am members as necessary (i.e. nutritionist or social worker).
- Visit 12 months after surgery with surgeon, bariatric physician, and other team members as necessary (i.e. nutritionist or social worker).
- Annual phone calls at years 1, 2 and 3 after surgery with bariatric care manager to monitor laboratory measures, weight loss, and complications.
All data to evaluate the effectiveness of SADI will be abstracted from the electronic medical record, These measures are taken from the patients as PART OF US UAL CARE. There are no specific measures added to usual care for the SADI procedure. We already have a protocol for the DS procedure. These data will include weight, height, laboratory results, diagnoses, utiliza tion of services, and pharmacy records. No questionnaires will be used in this study.
For each patient, data will be abstracted for 12 months before surgery and up to 3 years after surgery. No questionnaires will be administered.
The primary outcome for the study will be percent total weight loss at 3 years calculated as (weight at surgery - weight at 3 years)/weight at surgery. Data will be analyzed using linear regression to predict what factors at baseline such as disease burden, gender, age, race ethnicity, and BMI predict percent total weight loss at 3 years.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90034
- Kaiser Permanente Southern California West Los Angeles Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Total Weight Loss (change in weight relative to baseline)
Time Frame: 3 years
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12208 (REB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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