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

McMaster University

Status: Not yet enrolling

Conditions: Obesity

Treatments: Procedure: Duodenal Switch; Procedure: Duodenal-ileal Bypass with Sleeve Gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02692469

1366

Details and patient eligibility

About

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?

Full 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)

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Duodenal Switch Surgical Intervention

Active Comparator group

Description:

a DS procedure involves creating a sleeve gastrectomy with preservation of the pylorus, and creation of a Roux limb with a short common channel

Treatment:

Procedure: Duodenal Switch

Single Anastomosis Duodenal-Ileal Bypass

Experimental group

Description:

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

Treatment:

Procedure: Duodenal-ileal Bypass with Sleeve Gastrectomy