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NCT Number: NCT04767490

Single Anastomosis Versus Standard Duodenal Switch

Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion.

Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.

The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location status: Recruiting

Location contact

André Tchernof, MD

SUB_INVESTIGATOR

François Julien, MD

SUB_INVESTIGATOR

Laurent Biertho, MD

PRINCIPAL_INVESTIGATOR

Odette Lescelleur, MD

SUB_INVESTIGATOR

Simon Biron, MD

SUB_INVESTIGATOR

Simon Marceau, MD

SUB_INVESTIGATOR

Stéfane Lebel, MD

SUB_INVESTIGATOR

Suzy Laroche

CONTACT

[email protected]

418-656-8711 ext. 3841

About this study

Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Our team, with more than 4000 BPD-DS performed since the early 1990's, is recognized internationally for its expertise with this specific procedure.

Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.

This new procedure, called Single Anastomosis Duodenal Switch has the potential benefit of decreasing the complexity of the standard BPD-DS by avoiding one of the two intestinal anastomoses usually needed. This could potentially decrease the rate of peri-operative complications and increase access to this type of surgery.

However, the length of the common channel (250cm) is more than doubled compared to standard BPD-DS, which could also change significantly the outcomes of the procedure itself. Indeed, the length of the common channel conditions the absorption of fat and fat-soluble vitamins.

Currently, the scientific literature regarding this procedure is scarce, with only one author who published his 2-years outcomes, in a cohort study of 100 patients. In addition, this report presents major limitations. In example, the length of the omega loop was increased from 200 to 250cm during the course of the study, in order to decrease the rate of protein deficiency and reoperation for malnutrition. This and other limitations make it hard to assess the actual results of the technique.

The overall objective of this study is to assess in a stronger study design (i.e. a prospective randomized single blinded trial), the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years and ≤60 years
  • Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35
  • 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:
  • Inflammatory bowel disease (IBD),
  • Cirrhosis
  • History of gastric or duodenal ulcers
  • Preoperative hypoalbuminemia (<35 g/L)
  • History of severe renal, hepatic, cardiac or pulmonary disease
  • Past esophageal, gastric or bariatric surgery
  • Type 1 Diabetes
  • Pregnancy
  • Evidence of psychological problem that may affect the capacity to understand the project and to comply with the medical recommendations
  • History of drug use or alcohol abuse in the last 6 months
  • History of gastro-intestinal inflammatory diseases

Treatment and study plan

Standard duodenal switch

Procedure

Other names: BPD-DS

Single Anastomosis Duodenal Switch

Procedure

Other names: SADI

Primary outcomes

  1. Excess weight loss

    Time frame: 2 years

    Excess weight loss at 2 years of follow-up

    %EWL (Excess weight loss based on an ideal BMI = 25.) and change in BMI as compared to preoperative reference values

  2. Rate of protein deficiency or insufficiency

    Time frame: from baseline up to 60 months

    Rate of protein deficiency (<35gr/l) or insufficiency (<30gr/l)

  3. Mortality rate

    Time frame: from baseline up to 60 months

    Rate of mortality

  4. BMI

    Time frame: 2 years

    change in BMI at 2 years follow-up as compared to preoperative reference values

Secondary outcomes

  1. Complication rate

    Time frame: from baseline up to 60 months

    overall and surgery-specific complications

  2. Cure rate of comorbidities

    Time frame: from baseline up to 60 months

    Remission rate for comorbidities, including T2D, Hypertension, dyslipidemia, sleep apnea

  3. Rate of minerals and vitamin deficiencies

    Time frame: from baseline up to 60 months

    Rate of deficiency and insufficiency in mineral and vitamins

  4. Body composition by bioimpedance measures

    Time frame: from baseline up to 60 months

    body fat composition (%) assessed by biompedance

  5. Change in quality of life

    Time frame: from baseline up to 60 months

    36-item short form survey score from 0 to 100

  6. Change in quality of life

    Time frame: from baseline up to 60 months

    Bariatric Analysis and Reporting Outcomes System score from -7 to 9

  7. Change in quality of life

    Time frame: from baseline up to 60 months

    Laval Questionnaire score from 0 to 7

  8. Change in quality of life

    Time frame: from baseline up to 60 months

    GastroIntestinal Quality of Life Index from 0 to 144

  9. Change in gatroesophageal reflux symptom

    Time frame: from baseline to 60 months

    GastroEsophageal Reflus Disease Score from 0 to 72

Study contacts

Contact information is provided by the study sponsor or research team.

Mélanie Nadeau, MSc

CONTACT

[email protected]

418-656-8711 ext. 3490

Suzy Laroche

CONTACT

[email protected]

418-656-8711 ext. 3841

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Registry information

Official study title

Single Anastomosis Versus Standard Duodenal Switch - a Prospective Randomized Single-blinded Trial

Acronym: SADI

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
Feb 23, 2021
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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