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

Not Applicable

Not yet recruiting

• Conditions: Obesity
• Interventions: Procedure: Duodenal Switch; Procedure: Duodenal-ileal Bypass with Sleeve Gastrectomy

• Registration Number: NCT02692469
• Lead Sponsor: McMaster University

Brief Summary

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?

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)

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Status Verified: 2016-02
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-22
• Last Update Submitted: 2016-02-22
• Study First Posted: 2016-02-26
• Last Update Posted: 2016-02-26
• Study Start: 2016-04
• Primary Completion: 2021-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duodenal Switch Surgical Intervention	Duodenal Switch	a DS procedure involves creating a sleeve gastrectomy with preservation of the pylorus, and creation of a Roux limb with a short common channel
Single Anastomosis Duodenal-Ileal Bypass	Duodenal-ileal Bypass with Sleeve Gastrectomy	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

Primary Outcome Measures

Name	Time	Method
Excess weight loss	5 years	BMI and body weight will be measured and compared to preoperative reference values

Secondary Outcome Measures

Name	Time	Method
Remission of hypertension	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
Surgical complications	1 year	According to the Clavien-Dindo Classification of surgical complications
Metabolic alterations	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.
Remission of type 2 diabetes	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).