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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT02792166

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

To evaluate feasibility and short-term safety of SADI-S.
To evaluate short and long-term beneficial outcomes.
To evaluate and compare long-term morbidity.

Condition or Disease	Intervention/Treatment	Phase
Obesity Morbid Obesity	Procedure: BPD-DS Procedure: SADI-S	N/A

Detailed Description

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).
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.
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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BPD-DS BPD-DS involves creating a sleeve gastrectomy and creation of a Roux-en-Y bypass involving a Roux limb (150cm) which is anastomosed to the transected first-stage of the duodenum and a short common channel (100cm).	Procedure: BPD-DS Biliopancreatic Diversion with Duodenal Switch Other Names: Bariatric/metabolic surgery
Experimental: SADI-S SADI-S involves creating a sleeve gastrectomy but simplifies the bypass part of the BPD-DS by a single anastomosis of a loop of jejunum at 250cm from the ileocecal valve (longer common channel) to the transected first-stage of the duodenum instead of the Roux-en-Y construct.	Procedure: SADI-S Single Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy Other Names: Bariatric/metabolic surgery

Arm

Intervention/Treatment

Active Comparator: BPD-DS

BPD-DS involves creating a sleeve gastrectomy and creation of a Roux-en-Y bypass involving a Roux limb (150cm) which is anastomosed to the transected first-stage of the duodenum and a short common channel (100cm).

Procedure: BPD-DS

Biliopancreatic Diversion with Duodenal Switch

Other Names:

Bariatric/metabolic surgery

Experimental: SADI-S

SADI-S involves creating a sleeve gastrectomy but simplifies the bypass part of the BPD-DS by a single anastomosis of a loop of jejunum at 250cm from the ileocecal valve (longer common channel) to the transected first-stage of the duodenum instead of the Roux-en-Y construct.

Procedure: SADI-S

Single Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy

Other Names:

Bariatric/metabolic surgery

Outcome Measures

Primary Outcome Measures

Short-term Safety Assessment [30 days]
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).
Weight loss [5 years]
%EWL and change in BMI as compared to preoperative reference values

Secondary Outcome Measures

Long-term Morbidity Assessment [5 years]
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.
Remission of T2DM [5 years]
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)
Resolution/Improvement in other obesity related comorbidities [5 years]
Hypertension, Dyslipidemia, Obstructive sleep apnea, NAFLD/NASH
Quality of Life Assessment [5 years]
Quality of life status will be assessed using the SF-36 questionnaire at each follow-up visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)