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NCT Number: NCT07115836

Standard Versus "Single Loop" Bypass After Parietal Gastrectomy

Bilio-pancreatic bypass (BPD-DS) is the most effective type of bariatric surgery in terms of weight loss and treatment of obesity-related comorbidities such as type 2 diabetes. Nevertheless, the spread of this procedure is limited by the technical difficulties and long-term nutritional complications inherent in this operation.

Recently, a simplified "Duodenal Switch" technique has been proposed. This technique is known as "Single Anastomosis Duodeno-Ileal bypass" (SADI) and involves connecting the duodenum to the ileum, 250 cm upstream of the ileo-caecal valve, via an "omega" loop. This surgery is technically simpler and possibly less risky (particularly from a nutritional point of view) than the "standard" technique developed at the IUCPQ. This explains the enthusiasm in the surgical community for SADI, although the scientific evidence is very limited. The investigator has therefore initiated a prospective randomized study to compare standard bypass with single loop bypass as primary surgery.

In this study, the investigator aims to evaluate the results of SADI versus standard bypass, as 2nd-stage surgery after parietal gastrectomy.

The hypothesis is that SADI will be accompanied by fewer digestive and nutritional side effects, but also by a lower weight loss and a lower rate of recovery from comorbidities.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Criucpq-Ul

Québec, Quebec, G1V 4G5, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who had a parietal gastrectomy more than 18 months ago and
  • Who still meet NIH criteria for bariatric surgery (BMI ≥ 35kg/m2 with associated disease or BMI ≥ 40kg/m2) or
  • Have lost < 50% of their excess weight, or
  • Have significant weight regain (≥ 20% EWL)
  • Accepting long-term care and follow-up and willing to participate in this study after informed consent

Exclusion criteria

  • Other bariatric procedures apart from parietal gastrectomy.
  • Psychiatric illness not stabilized for more than 6 months
  • Severe illness with life-threatening consequences within 5 years
  • Diagnosis of cancer within the last 3 years
  • Chronic digestive disorders (chronic diarrhea, inflammatory diseases, cirrhosis, intestinal resections, functional abdominal pain)
  • Pregnancy or desire for pregnancy within 2 years
  • Intellectual retardation making consent impossible or patient under guardianship

Treatment and study plan

Standard duodenal switch

Procedure

Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)

Single-anastomosis duodenal switch

Procedure

Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)

Primary outcomes

  1. Weight loss

    Time frame: from baseline to 60 months

    % Excess weights loss

Secondary outcomes

  1. Mortality rate

    Time frame: from baseline to 60 months

    Mortality rate

  2. Early complications

    Time frame: from baseline to 30 days

    Complication (≤30 days) graded with Clavien classification

  3. Late complications

    Time frame: from 30 days to 60 months

    Complication (>30 days to 60 months) ga=raded with Clavien classification

  4. Operating time

    Time frame: baseline

    Operating time in minutes

  5. Blood loss

    Time frame: baseline

    Peroperative blood loss (ml) as reported in the operating room

  6. Hospital stay

    Time frame: baseline

    length of hospital stay (days)

  7. Change in quality of life (QLaval)

    Time frame: from baseline to 60 months

    Change in quality of life assessed by the Laval questionnaire evaluating 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life

  8. Change in quality of life (SF36)

    Time frame: from baseline to 60 months

    change in quality of life assessed with the 36-item short form survey evaluating quality of life on a scale form 0 to 100, higher scores indicate better quality of life

  9. Digestive side effects (GERD)

    Time frame: from baseline to 60 months

    Evaluation of gastro-oesophageal reflux symptoms using the GERD Score questionnaire, on a scale from 0 to 72, higher scores indicating greater symptoms

  10. Digestive side effects (LARS)

    Time frame: baseline to 60 months

    Evaluation of bowel function using the LARS questionnaire, on a scale from 0 to 42, with higher scores indicating greater symptoms

  11. Digestive side effect (GIQLI)

    Time frame: from baseline to 60 months

    Evaluation of digestive side effect using the Laval digestive problems evaluation questionnaire, on a scale from 0 to 144, with higher scores indicating less negative impact of symptoms

  12. Malnutrition rate

    Time frame: from baseline to 60 months

    Malnutrition rate using albuminemia (mild 30-34.9g/L; moderate 25-29.9g/L; severe <25g/L)

  13. Nutrient deficiency rate

    Time frame: from baseline to 60 months

    Nutrient deficiency rate based on blood analysis of vitamine A, vitamin D, vitamin B12, Calcium, magnsium, phosphorus, iron, ferritin, TIBC and parathormone and the required dose of supplements

  14. Resolution of associated comorbidities

    Time frame: from baseline to 60 months

    Type 2 diabetes, hypertension, sleep apnea and dislipidemia evolution are evaluated according to treatment, symptoms, vital signs and blood test results to determine whether there has been resolution, improvement, no change, deterioration, or recurrence of the condition according to the criteria of the American Society for Metabolic & Bariatric Surgery.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Fondation de l'Institut universitaire de cardiologie et pneumologie de Québec

Registry information

Official study title

Standard Versus "Single Loop" Bypass After Parietal Gastrectomy: a Randomized Double-blind Study

Important dates

Study start
2017
Primary completion
2025
Study completion
2028
First posted
Aug 11, 2025
Registry last updated
Dec 8, 2025

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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