Laparoscopic Single-Anastomosis Duodenal-Jejunal Bypass With Sleeve Gastrectomy vs Laparoscopic Duodenal Switch (DSvsSADI)

February 22, 2016 updated by: Dennis Hong MD, McMaster University

Laparoscopic Single-Anastomosis Duodenal-Jejunal Bypass With Sleeve Gastrectomy vs Laparoscopic Duodenal Switch as a Primary Bariatric Procedure. 5 Year Patient Follow

Will a laparoscopic Single-Anastomosis Duodenal-ileal Bypass with Sleeve Gastrectomy produce similar or superior results when compared to a laparoscopic Duodenal Switch, as a primary surgical procedure for weight loss in bariatric patients over a 5 year period?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The aims of this study are: (a) to compare SADI vs DS as a primary bariatric procedure for weight loss; (b) to compare the minor and major complications of SADI vs DS (c) to compare SADI vs DS for remission rates of type 2 diabetes (d) to compare SADI vs DS for remission rates of hypertension (e) to compare SADI vs DS for weight regain at 5 years (f) to compare SADI vs DS for metabolic alterations. The investigators hypothesize that both procedures will have similar weight loss and metabolic remission results. If the complication rates of SADI are similar or superior to the complication rates of the DS, then the investigators could propose the SADI as a viable alternative to the DS in patients with high BMIs requiring increased weight loss.

The investigators will conduct a prospective randomized study. The study will include 140 patients who are scheduled for bariatric procedures. The patients will be stratified into 2 groups. The first group will continue according to the standard bariatric preoperative protocol and will be assigned to a DS. The second group will also follow standard bariatric preoperative protocol but will be assigned to a SADI. Follow up of all patients will continue according to the usual bariatric clinic guidelines.

From literature, the mean excess body weight loss is 77.65% with standard deviation of 21% for Duodenal Switch bariatric surgery. If there is in truth no difference between the Duodenal Switch and SADI for excess body weight loss, then 140 patients (70 per group) are required to have 80% power for the lower limit of a one-sided 97.5% confidence interval (or equivalently a 95% two-sided confidence interval) will be above the non-inferiority limit of -10%.

Participants must meet ALL of the following inclusion criteria:

  • Fulfilled criteria for bariatric surgery as coined by National Institutes of Health.
  • Their age is ≥18 years and ≤70 years
  • Able and willing to give written consent

Participants who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:

  • Contra-indication to general anesthesia
  • Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
  • Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
  • History of alcohol abuse (>30 g/day in men or >20 g/day in women)

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must meet ALL of the following inclusion criteria:

    • Fulfilled criteria for bariatric surgery as coined by National Institutes of Health.
    • Their age is ≥18 years and ≤70 years
    • Able and willing to give written consent

Exclusion Criteria:

  • Participants who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:

    • Contra-indication to general anesthesia
    • Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
    • Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
    • History of alcohol abuse (>30 g/day in men or >20 g/day in women)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Duodenal Switch Surgical Intervention
a DS procedure involves creating a sleeve gastrectomy with preservation of the pylorus, and creation of a Roux limb with a short common channel
Procedure: Duodenal Switch
Bariatric procedure
Other Names:
  • DS
Experimental: Single Anastomosis Duodenal-Ileal Bypass
The SADI defers from the DS in that after the duodenum is separated from the stomach, preserving the pylorus, a loop of bowel 200 cm from the ileo-cecal valve is anastomosed with the pylorus, thus requiring only one anastomosis
Procedure: Duodenal-ileal Bypass with Sleeve Gastrectomy
Bariatric procedure
Other Names:
  • SADI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excess weight loss
Time Frame: 5 years
BMI and body weight will be measured and compared to preoperative reference values
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission of type 2 diabetes
Time Frame: 5 years

The presence and remission of type 2 diabetes will be diagnosed according to the American Diabetes Association's current criteria:

  1. A1C ≥6.5 percent, OR
  2. FPG ≥126 mg/dL (7.0 mmol/L), OR
  3. Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an OGTT, OR
  4. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L).
5 years
Remission of hypertension
Time Frame: 5 years

The presence and remission of hypertension will be diagnosed by the definitions suggested in 2003 by the seventh report of the Joint National Committee (JNC 7) and are based upon the average of two or more properly measured readings at each of two or more office visits after an initial screen:

  • Normal blood pressure: systolic <120 mmHg and diastolic <80 mmHg
  • Prehypertension: systolic 120 to 139 mmHg or diastolic 80 to 89 mmHg (see "Prehypertension")

  • Hypertension:

    • Stage 1: systolic 140 to 159 mmHg or diastolic 90 to 99 mmHg
    • Stage 2: systolic ≥160 mmHg or diastolic ≥100 mmHg
5 years
Surgical complications
Time Frame: 1 year
According to the Clavien-Dindo Classification of surgical complications
1 year
Metabolic alterations
Time Frame: 5 years

Blood levels will be measured pre-operatively a on a regular schedule after surgery for:

zinc, magnesium, phosphate, albumin, PTH, HbA1C, ferritin, calcium, Iron binding capacity, total proteins, Hb, Cholesterol levels, LDL, Vit. D, Vit. A and Vit. B12 to ensure they are in normal range.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Dennis Hong, MD FRCSC, St. Joseph Healthcare Hamilton, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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