Clinical trial NCT02692469: Laparoscopic Single-Anastomosis Duodenal-Jejunal Bypass With Sleeve Gastrectomy vs Laparoscopic Duodenal Switch
Official title: Laparoscopic Single-Anastomosis Duodenal-Jejunal Bypass With Sleeve Gastrectomy vs Laparoscopic Duodenal Switch as a Primary Bariatric Procedure. 5 Year Patient Follow
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Bariatric Surgery, Obesity, Laparoscopy
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Excess weight loss
timeFrame: 5 years
Secondary outcomes:
measure: Remission of type 2 diabetes
timeFrame: 5 years
measure: Remission of hypertension
timeFrame: 5 years
measure: Surgical complications
timeFrame: 1 year
measure: Metabolic alterations
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: St. Joseph Healthcare Hamilton, McMaster University
name: Dennis Hong, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanchez-Pernaute A, Rubio Herrera MA, Perez-Aguirre E, Garcia Perez JC, Cabrerizo L, Diez Valladares L, Fernandez C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. doi: 10.1007/s11695-007-9287-8. Epub 2007 Nov 27.
citation: Sanchez-Pernaute A, Herrera MA, Perez-Aguirre ME, Talavera P, Cabrerizo L, Matia P, Diez-Valladares L, Barabash A, Martin-Antona E, Garcia-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.
citation: Sanchez-Pernaute A, Rubio MA, Perez Aguirre E, Barabash A, Cabrerizo L, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy: metabolic improvement and weight loss in first 100 patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):731-5. doi: 10.1016/j.soard.2012.07.018. Epub 2012 Aug 7.
citation: Sovik TT, Taha O, Aasheim ET, Engstrom M, Kristinsson J, Bjorkman S, Schou CF, Lonroth H, Mala T, Olbers T. Randomized clinical trial of laparoscopic gastric bypass versus laparoscopic duodenal switch for superobesity. Br J Surg. 2010 Feb;97(2):160-6. doi: 10.1002/bjs.6802.