Omega Gastric Bypass (150cm) Compared to the Roux-en-Y Gastric Bypass (YOMEGA-2 Multicentric Trial)

Not Applicable

Recruiting

• Conditions: Obesity; Morbid
• Interventions: Procedure: Laparoscopic OAGB; Procedure: Laparoscopic RYGB

• Registration Number: NCT06057597
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Obesity with its consequences such as type 2 diabetes, high blood pressure, dyslipidemia, fatty liver disease, sleep apnea and cancers, remains a major healthcare problem worldwide. Bariatric surgery, combined with nutritional education and close monitoring, has been shown to be the most effective treatment for patients with morbid obesity resulting in significant and lasting weight loss and improvements in co-morbidities . With nearly 50000 procedures per year France ranks third in the world in terms of care for patients suffering from morbid (BMI ≥ 40 kg/m²) and severe (BMI 35-40 kg/m²) obesity.

In parallel with the significant increase in the number of patients operated on for obesity in the world, over the past two decades, significant development has been observed in the field of bariatric surgery with a decrease or even disappearance of some procedures and the appearance of others.

Performed for more than 40 years, the Roux-en-Y Gastric Bypass (RYGB) is a restrictive and malabsorptive procedure and currently is considered as gold standard procedure for the treatment of morbid obesity and its comorbidities. However, despite the good effectiveness (with an average Excess Weight Loss % (EWL%) of approximatively 70% at 2 years), RYGB is technically demanding procedure with learning curve requiring more than 100 cases and an overall complication rate ranging from 10% to 20% Introduced in 2001, one anastomosis gastric bypass (OAGB) is a modified gastric bypass that consists of a single gastrojejunal anastomosis between a long gastric pouch and a jejunal (biliopancreatic) omega loop. In Sept. 2019, taking into account the results from YOMEGA trial, the French High Authority for Health (Haute Autorité de Santé (HAS)) recommended to ban OAGB with 200 cm or longer BPL and urged to assess the efficacy and safety of OAGB with 150 cm BPL in a randomized controlled trial. Indeed, YOMEGA-2 trial is logical continuity of the YOMEGA trial.

The aim of this study is to assess weight loss efficiency and the nutritional safety of the OAGB-150 in comparison to a standard (RYGB).

The hypothesis of this study is that the OAGB with a 150 cm BPL could have the same efficacy on weight loss and nutritional complication rate in comparison to the RYGB at 2 years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Status Verified: 2023-11
• Study Start: 2023-11-13
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2027-10-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

• Patient aged from 18 to 65 years old
• Type III obesity (BMI ≥ 40 kg/m²), or Type II obesity BMI 35-40 kg/m2 associated with at least one co-morbidity which will be improved by surgery (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis)
• Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter pylori within 12 months before surgery
• Patient who has benefited from a multidisciplinary evaluation at least 6 months, with a favorable opinion for a gastric bypass
• Patient who understood and accepted the need for a long-term follow-up
• Patient who agreed to be included in the study and who signed the informed consent form
• Patient affiliated to a social security scheme
• For child-bearing aged women, efficient contraception

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Exclusion Criteria

• History of previous bariatric surgery
• History of chronic inflammatory bowel disease
• Presence of chronic diarrhea
• Presence of a severe and evolutive life threatening pathology
• Presence of dysplastic modifications of the gastric mucosa, chronic atrophic gastritis or history of gastric cancer
• Presence of an unhealed gastro-duodenal ulcer
• Presence of Helicobacter pylori resistant to medical treatment
• Presence of esophagitis
• Pregnancy or desire to be pregnant during the study
• Mentally unbalanced patients, under supervision or guardianship
• Patients who don't understand French and not able to give consent
• Patient included and followed in another interventional trial
• Unable to consent, under tutelage or curatorship, or judiciary safeguard

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Laparoscopic OAGB	This corresponds to patients with type 2 obesity (BMI 35-40) with comorbidities (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis) and type 3 obesity (BMI ≥ 40 kg/m²) and candidates for bariatric surgery. Laparoscopic OAGB will be performed with long and narrow gastric pouch (30cc) and 150 cm biliopancreatic limb
Control Groupe	Laparoscopic RYGB	This corresponds to patients with type 2 obesity (BMI 35-40) with comorbidities (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis) and type 3 obesity (BMI ≥ 40 kg/m²) and candidates for bariatric surgery. Standard laparoscopic RYGB will be performed with a gastric pouch (30cc) and 150 cm antecolic Roux limb and a 50 cm biliopancreatic limb.

Primary Outcome Measures

Name	Time	Method
To demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on weight loss (efficacy).	2 years after the surgery	For each patient co-primary endpoints will be assessed at 2 years after surgery composed by: Efficacy: Weight loss according to Excess Weight Loss % (EWL%) calculated using the following formula: ((weight 2 years after surgery - initial weight) / (initial weight - ideal weight)) x 100. Ideal weight defined as the weight corresponding to a BMI = 25 kg/m².; The assessment of the primary co-endpoint will be standardized between the sites.
To demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on nutritional complication rate (safety)	2 years after the surgery	For each patient co-primary endpoints will be assessed at 2 years after surgery composed by: Safety: Nutritional complications defined by at least one vitamin deficiency (vit. B1 \< 66nmol/l or B12 \< 145pmol/l), malnutrition (albumin \< 30g/l), anemia (hemoglobin \< 10g/dl) or a combination of these.; The assessment of the primary co-endpoint will be standardized between the sites.

Secondary Outcome Measures

Name	Time	Method
Measurement of % of transferrin saturation	Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of % of transferrin saturation will explore the nutritional status of patients. Results will be expressed in %
Measurement of zinc	Before surgery and 6, 12 months and 24 months after surgery	Measurement of zinc will explore the nutritional status of patients. Results will be expressed in mmol/L
Measurement of vitamin A	Before surgery and 6, 12 and 24 months after surgery	Measurement of vitamin A will explore the nutritional status of patients. Results will be expressed in mmol/l
Measurement of albumin	Before and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l
Measurement of pre-albumin	Before and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of pre-albumin will explore the nutritional status of patients. Results will be expressed in g/l
Measurement of prothrombin rate	Before surgery and 6, 12 and 24 months after surgery	Measurement of prothrombin rate will explore the nutritional status of patients. Results will be expressed in %
Measurement of HDL	Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Measurement of calcium	Before and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of calcium will explore the nutritional status of patients. Results will be expressed in mmol/l
Measurement of hemoglobin	Before and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l
Measurement of ferritin	Before and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in μg/l
Measurement of iron	Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of iron will explore the nutritional status of patients. Results will be expressed in mmol/l
Measurement of vitamin E	Before surgery and 6, 12 and 24 months after surgery	Measurement of vitamin E will explore the nutritional status of patients. Results will be expressed in mmol/l
Measurement of vitamin B1	Before surgery and 6, 12 and 24 months after surgery	Measurement of vitamin B1 will explore the nutritional status of patients. Results will be expressed in nmol/l
Measurement of vitamin B9	Before surgery and 6, 12 and 24 months after surgery	Measurement of vitamin B9 will explore the nutritional status of patients. Results will be expressed in nmol/l
Measurement of vitamin B12	Before surgery and 6, 12 and 24 months after surgery	Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l
Measurement of the 24-hour steatorrhea rate	6 month after surgery	Measurement of the average number of stool will explore the nutritional status of patients. Results will be expressed in number of stool/day
Measurement of vitamin D	Before surgery and 6, 12 and 24 months after surgery	Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l
Measurement of HbA1c	Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %
Measurement of fasting glycemia	Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Measurement of LDL	Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Evaluation of antihypertensive drugs	Before surgery and 6, 12 and 24 months after surgery	Assessment of the number of antihypertensive medications will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.
Hospitalization length	The last day of hospitalization	The Length of stay (in days) is based on the number of days of hospitalization from surgery (day of surgery = D0) until the end of hospitalization.
Occurrence of kidney stone	Within 2 years after surgery	For each visit after the surgery, the presence or not of kidney stones will be documented and if applicable the treatment will be noted
Severity of early complications	Within 30 days after surgery	Severity of early complications (within 30 days) for each procedure according to the Dindo-Clavien classification
Measurement of cholesterol	Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Measurement of triglycerides	Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery	Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l
Evaluation of the use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea	Before surgery and 6, 12 and 24 months after surgery	Evolution of the use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of the use or discontinuation of the use of Continuous Positive Airway Pressure machine
Body composition	Before and 24 months after surgery.	Body composition level on a subsample of the total population: By impedancemetry : * Muscle mass index in kg/m2; * Non-fat mass index in kg/m2; * Fat mass index in kg/m2
Sarcopenia level	Before and 24 months after surgery.	Sarcopenia level on a subsample of the total population will be assessed by Handgrip Strength
Type of early complications	Within 30 days after surgery	Type (medical or surgical) of early complications (within 30 days) for each procedure.
Evaluation of antidiabetic drugs	Before surgery and 6, 12 and 24 months after surgery	Assessment of number of antidiabetic medications will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.
Evaluation of antilipidemic drugs	Before surgery and 6, 12 and 24 months after surgery	Assessment of the number of antilipidemic medications will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment
Severity of late complications	Within 2 years after surgery	Severity of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
Gastroesophageal reflux assessment	Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery	Evolution of gastroesophageal reflux will be assessed at each study visit, before and after surgery. This outcome will be expressed in terms of improvement, aggravation or onset.
Number of patients readmitted	30 days after surgery	Number of patients readmitted within 30 days after surgery.
Overall complications rate	Within 24 months after surgery	Rate of medical and surgical (\> or = grade III) complications within 24 months after surgery using the Dindo-Clavien classification, described as : Grade I = Any deviation from the normal postoperative course. Grade II = Requiring pharmacological treatment with drugs other than such allowed for grade I complications.; Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.
Type of late complications	Within 2 years after surgery	Type (medical or surgical) of late complications (after 30 days) for each procedure.
Absolute weight loss assessment	1, 3, 6, 12, 18 and 24 months after surgery	Weight loss at 1, 3, 6, 12, 18 and 24 months after surgery, according to absolute weight loss (aWL) in kg.
Excess Weight Loss percentage assessment	1, 3, 6, 12, 18 and 24 months after surgery	Weight loss at 1, 3, 6, 12, 18 and 24 months after surgery, according to Excess Weight Loss percentage (EWL%), calculated using the following formula: ((weight at visit X - initial weight) / (initial weight - ideal weight)) X 100
Excess BMI Loss percentage assessment	1, 3, 6, 12, 18 and 24 months after surgery	Weight loss at 1, 3, 6, 12, 18 and 24 months after surgery, according Excess BMI Loss percentage (EBL%), according to the formula : ((BMI at visit X - initial BMI) / (initial BMI - ideal BMI)) X 100 with Ideal BMI = 25 kg/m²
Quality of life assessed with GIQLI questionnaire	Before surgery and at 6, 12 and 24 months after surgery	This questionnaire consists of 36 items exploring 5 dimensions or subscales: symptoms, physical condition, emotions, social integration and the effect of any medical treatment. For each item, 5 responses will be proposed to the patients and for each answer, a score ranging from 0 to 4 (highest score = 144) will be assigned. A high score defines a more favorable health state
Quality of life assessed with SF36 questionnaire	Before surgery and at 6, 12 and 24 months after surgery	This questionnaire taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/tiredness, and general health perceptions. It also includes a single item that provides an indication of a perceived change in health
Quality of life assessed with Sigstad questionnaire	Before surgery and at 1, 3, 6, 12, 18 and 24 months after surgery	The Sigstad questionnaire allows the identification and diagnosis of postoperative dumping syndrome and early hypoglycaemia: a score \>7 suggests a dumping syndrome

Trial Locations

Locations (1)

Hôpital Bichat Claude-Bernard; 🇫🇷 Paris, France