Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S): A Prospective Cohort Study

Obesity Clinical Trial

Official title:

Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S): A Prospective Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02792166
• Other study ID #: 15-588 MUHC
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: March 2025

Study information

• Verified date: May 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The prevalence of morbid obesity in Canada has risen almost 5 fold in the past three decades. Surgery remains the cornerstone of treatment of obesity and related comorbidities such as type-2 diabetes. Bariatric/metabolic procedures can be classified into 2 main categories: a) those that cause restriction, and b) those that add a malabsorptive component to restriction. Currently sleeve gastrectomy (SG), which is a purely restrictive operation, is the most frequently performed procedure in North America.

Interestingly, combined restrictive/malabsorptive procedures such as Roux-en-Y gastric bypass (RYGB) or biliopancreatic diversion with duodenal switch (BPD-DS) are more effective procedures when compared to purely restrictive ones. Moreover, the conventional BPD-DS procedure has been shown to be significantly more effective than RYGB in achieving durable weight loss and resolving comorbidities such as type-2 diabetes. Despite superior outcomes, the performance of BPD-DS is highly institution dependant and comprises less than 5% of the annual bariatric procedures performed worldwide.

Common reservations against BPD-DS are related to the side effects of the procedure, and include frequent bowel movements, flatulence, fat, micronutrient and protein malnutrition. Furthermore, longer operative times and surgical technical challenges are also reasons for lower prevalence of the BPD-DS procedure.

Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification of the conventional BPD-DS that potentially addresses many of these concerns. In addition, it is a suitable second-stage or salvage procedure for severely obese patients with inadequate weight loss or resolution of obesity-related comorbidities after SG. Despite showing excellent results of up to 5 years with acceptable postoperative morbidity, all the literature on SADI-S originates from a single center and has not been compared directly with BPD-DS. Hence, the investigators aim to evaluate the feasibility, safety, and postoperative outcomes of SADI-S as it compares to conventional BPD-DS in morbidly obese patients.

This project has three specific aims:

1. To evaluate feasibility and short-term safety of SADI-S.

2. To evaluate short and long-term beneficial outcomes.

3. To evaluate and compare long-term morbidity.

Description:

The prevalence of morbid obesity in Canada has risen almost 5 fold in the past three decades. Surgery remains the cornerstone of treatment of obesity and related comorbidities such as type-2 diabetes. Bariatric/metabolic procedures can be classified into 2 main categories: a) those that cause restriction, and b) those that add a malabsorptive component to restriction. Currently sleeve gastrectomy (SG), which is a purely restrictive operation, is the most frequently performed procedure in North America.

Interestingly, combined restrictive/malabsorptive procedures such as Roux-en-Y gastric bypass (RYGB) or biliopancreatic diversion with duodenal switch (BPD-DS) are more effective procedures when compared to purely restrictive ones. Moreover, the conventional BPD-DS procedure has been shown to be significantly more effective than RYGB in achieving durable weight loss and resolving comorbidities such as type-2 diabetes. Despite superior outcomes, the performance of BPD-DS is highly institution dependant and comprises less than 5% of the annual bariatric procedures performed worldwide.

Common reservations against BPD-DS are related to the side effects of the procedure, and include frequent bowel movements, flatulence, fat, micronutrient and protein malnutrition. Furthermore, longer operative times and surgical technical challenges are also reasons for lower prevalence of the BPD-DS procedure.

Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification of the conventional BPD-DS that potentially addresses many of these concerns. In addition, it is a suitable second-stage or salvage procedure for severely obese patients with inadequate weight loss or resolution of obesity-related comorbidities after SG. Despite showing excellent results of up to 5 years with acceptable postoperative morbidity, all the literature on SADI-S originates from a single center and has not been compared directly with BPD-DS. Hence, the investigators aim to evaluate the feasibility, safety, and postoperative outcomes of SADI-S as it compares to conventional BPD-DS in morbidly obese patients. Our project has three specific aims:

1. To evaluate feasibility and short-term safety of SADI-S. The investigators will assess operative parameters (e.g. procedure time, inadvertent injuries, need for conversion to laparotomy, and transfusion of blood products) and 30-day postoperative adverse events (e.g. length of stay, superficial/deep surgical site infection, leak, venous thromboembolism (VTE), need for reintervention and readmission).

2. To evaluate short and long-term beneficial outcomes. The investigators will evaluate and compare excess weight loss, resolution of type-2 diabetes and other comorbidities, and changes in quality of life at 1, 6, 12 months and yearly thereafter for both groups.

3. To evaluate and compare long-term morbidity. The investigators will evaluate and compare both groups at 6, 12 months and yearly thereafter following surgery for long-term morbidities (e.g. frequency of bowel movements, fat malabsorption, micronutrient and protein-calorie malnutrition, need for supplemental nutrition, internal/incisional hernia, and gastro-esophageal reflux).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Participants must meet ALL of the following inclusion criteria:

• Age =18 years and =60 years

• Fulfill criteria for bariatric surgery as coined by National Institutes of Health

• Give written informed consent

Exclusion Criteria:

Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:

• Presence of the following baseline comorbidities:

• Congestive heart failure (CHF),

• Chronic kidney disease (CKD) stage 3-5 (or GFR <60 ml/min per 1.73 m2),

• Inflammatory bowel disease (IBD),

• Pulmonary hypertension (PHTN),

• Cirrhosis.

• Severe gastroesophageal reflux disorder (GERD) +/- presence of any Barrett's disease

• Individuals who were found by any member of the multidisciplinary team (nutritionist, nurse, psychologist, and surgeon) to be at risk for lack of support and poor compliance (e.g. =2 missed appointments without a valid justification)

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• BPD-DS
Biliopancreatic Diversion with Duodenal Switch
• SADI-S
Single Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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). On — View 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):1 — View Citation

Sanchez-Pernaute A, Rubio MA, Cabrerizo L, Ramos-Levi A, Perez-Aguirre E, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) for obese diabetic patients. Surg Obes Relat Dis. 2015 Sep-Oct;11(5):1092-8. doi: 10.1016/j.soard.2 — View Citation

Sanchez-Pernaute A, Rubio MA, Conde M, Arrue E, Perez-Aguirre E, Torres A. Single-anastomosis duodenoileal bypass as a second step after sleeve gastrectomy. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):351-5. doi: 10.1016/j.soard.2014.06.016. Epub 2014 Jul 10. — View 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term Safety Assessment	To evaluate feasibility and short-term safety of SADI-S, we will assess operative parameters (procedure time, inadvertent injuries, need for conversion to laparotomy, and transfusion of blood products) and 30-day postoperative adverse events (length of stay, superficial/deep surgical site infection, leak, venous thromboembolism (VTE), need for reintervention and readmission).	30 days
Primary	Weight loss	%EWL and change in BMI as compared to preoperative reference values	5 years
Secondary	Long-term Morbidity Assessment	Postoperatively at 1, 6, 12 months and yearly thereafter for 5 years both groups will be compared for incidence of long-term morbidities including frequency of bowel movements, fat malabsorption, micronutrient and protein-calorie malnutrition, need for supplemental nutrition, internal/incisional herniation, and worsening versus de novo GERD.; At each visit protein (albumin, total protein) and vitamin/micronutrient levels (calcium, magnesium, iron, zinc, copper, selenium, vitamins A/E/D/K/B1/B6/B12) will be monitored using respective blood tests.	5 years
Secondary	Remission of T2DM	The presence of T2DM will be diagnosed according to the American Diabetes Association's current criteria: HbA1C =6.5 percent, OR; FPG =126 mg/dL (7.0 mmol/L), OR; 2-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
Secondary	Resolution/Improvement in other obesity related comorbidities	Hypertension, Dyslipidemia, Obstructive sleep apnea, NAFLD/NASH	5 years
Secondary	Quality of Life Assessment	Quality of life status will be assessed using the SF-36 questionnaire at each follow-up visit.	5 years