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

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ClinicalTrials.gov Identifier: NCT02792166
Recruitment Status : Recruiting
First Posted : June 7, 2016
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Amin Andalib, McGill University

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:

  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.

Condition or disease Intervention/treatment Phase
Obesity Morbid Obesity Procedure: BPD-DS Procedure: SADI-S Not Applicable

Detailed 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).

Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2024

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 Name: 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 Name: Bariatric/metabolic surgery




Primary Outcome Measures :
  1. Short-term Safety Assessment [ Time Frame: 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).

  2. Weight loss [ Time Frame: 5 years ]
    %EWL and change in BMI as compared to preoperative reference values


Secondary Outcome Measures :
  1. Long-term Morbidity Assessment [ Time Frame: 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.


  2. Remission of T2DM [ Time Frame: 5 years ]

    The presence of T2DM will be diagnosed according to the American Diabetes Association's current criteria:

    1. HbA1C ≥6.5 percent, OR
    2. FPG ≥126 mg/dL (7.0 mmol/L), OR
    3. 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an OGTT, OR
    4. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L)

  3. Resolution/Improvement in other obesity related comorbidities [ Time Frame: 5 years ]
    Hypertension, Dyslipidemia, Obstructive sleep apnea, NAFLD/NASH

  4. Quality of Life Assessment [ Time Frame: 5 years ]
    Quality of life status will be assessed using the SF-36 questionnaire at each follow-up visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792166


Contacts
Contact: Amin Andalib, MD MSc FRCSC 514-934-1934 ext 31531 amin.andalib@mcgill.ca

Locations
Canada, Quebec
McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Amin Andalib, MD MSc FRCSC    514-934-1934 ext 31531    amin.andalib@mcgill.ca   
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Amin Andalib, MD MSc FRCSC McGill University

Publications of Results:
Responsible Party: Amin Andalib, MD MSc FRCSC, McGill University
ClinicalTrials.gov Identifier: NCT02792166     History of Changes
Other Study ID Numbers: 15-588 MUHC
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Amin Andalib, McGill University:
Morbid obesity
Metabolic syndrome
Metabolic surgery
Bariatric surgery
SADI
BPD-DS

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms