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

Obesity Clinical Trial

— DSvsSADI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02692469
• Other study ID #: 1366
• Status: Not yet recruiting
• Phase: N/A
• First received: February 3, 2016
• Last updated: February 22, 2016
• Start date: April 2016
• Est. completion date: April 2026

Study information

• Verified date: February 2016
• Source: McMaster University
• Contact: Dennis Hong, MD FRCSC
• Phone: 905 522-1155
• Email: dennishong70[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: April 2026
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Duodenal Switch
Bariatric procedure
• Duodenal-ileal Bypass with Sleeve Gastrectomy
Bariatric procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

References & Publications (4)

Sánchez-Pernaute A, Herrera MA, Pérez-Aguirre ME, Talavera P, Cabrerizo L, Matía P, Díez-Valladares L, Barabash A, Martín-Antona E, García-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). On — View Citation

Sánchez-Pernaute A, Rubio Herrera MA, Pérez-Aguirre E, García Pérez JC, Cabrerizo L, Díez Valladares L, Fernández C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1 — View Citation

Sánchez-Pernaute A, Rubio MÁ, Pérez 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. do — View Citation

Søvik TT, Taha O, Aasheim ET, Engström M, Kristinsson J, Björkman S, Schou CF, Lönroth 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess weight loss	BMI and body weight will be measured and compared to preoperative reference values	5 years	No
Secondary	Remission of type 2 diabetes	The presence and remission of type 2 diabetes will be diagnosed according to the American Diabetes Association's current criteria: A1C =6.5 percent, OR; FPG =126 mg/dL (7.0 mmol/L), OR; Two-hour plasma glucose =200 mg/dL (11.1 mmol/L) during an OGTT, OR; In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose =200 mg/dL (11.1 mmol/L).	5 years	No
Secondary	Remission of hypertension	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	No
Secondary	Surgical complications	According to the Clavien-Dindo Classification of surgical complications	1 year	Yes
Secondary	Metabolic alterations	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	No