Standard Versus "Single Loop" Bypass After Parietal Gastrectomy

N/AActive Not RecruitingNCT07115836

Laval University63 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obesity, Morbid Obesity

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Weight loss

% Excess weights loss

Time frame: from baseline to 60 months

Secondary Outcomes

Mortality rate

Time frame: from baseline to 60 months

Early complications

Complication (≤30 days) graded with Clavien classification

Time frame: from baseline to 30 days

Late complications

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

Time frame: from 30 days to 60 months

Operating time

Operating time in minutes

Time frame: baseline

Blood loss

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

Time frame: baseline

Hospital stay

length of hospital stay (days)

Time frame: baseline

Change in quality of life (QLaval)

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

Time frame: from baseline to 60 months

Change in quality of life (SF36)

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

Time frame: from baseline to 60 months

Digestive side effects (GERD)

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

Time frame: from baseline to 60 months

Digestive side effects (LARS)

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

Time frame: baseline to 60 months

Digestive side effect (GIQLI)

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

Time frame: from baseline to 60 months

Malnutrition rate

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

Time frame: from baseline to 60 months

Nutrient deficiency rate

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

Time frame: from baseline to 60 months

Resolution of associated comorbidities

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.

Time frame: from baseline to 60 months

Standard Versus "Single Loop" Bypass After Parietal Gastrectomy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes