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Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass

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ClinicalTrials.gov Identifier: NCT02475590
Recruitment Status : Active, not recruiting
First Posted : June 18, 2015
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
IRCAD
Information provided by (Responsible Party):
IHU Strasbourg

Brief Summary:
Prospective randomized clinical trial aiming to compare laparoscopic Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) with primary outcome on excess weight loss, and secondary outcomes on nutritional status, glycolipid profile, quality of life and pain assessments.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Laparoscopic sleeve gastrectomy Procedure: Laparoscopic Roux-en-Y gastric bypass Not Applicable

Detailed Description:

No consensus is proposed by the Medical and Surgical societies to define and / or prioritize surgical procedures in obesity surgery. Indications are based on patient's age, sex, dietary habits, the importance of overweight and associated comorbidities and even if rarely admitted, based on knowledge of surgical teams and the cost of interventions. Given the decrease of gastric banding procedures, Roux-en-Y gastro-jejunal bypass is often considered the reference procedure.

The gastric bypass, developed in the 60s, is performed laparoscopically since the early 90s. It allows for a 60% to 70% excess weight loss with control over 75% of comorbidities. It is recommended to follow these patients long-term because late complications can occur. These patients require ongoing information and regular monitoring. They must also have a hyper-protein diet and a vitamin substitute long-term (multivitamins, vitamin B12, calcium ...).

The Sleeve gastrectomy (SG) arises as an alternative to RYGB. It was classically proposed to patients with a BMI greater than 60 and significant comorbidities since the procedure let to a significant weight reduction in patients for whom any other procedure was too difficult to perform. The quality of the weight loss achieved in these patients has led many teams to analyze the results of this intervention without conducting an additional procedure. It appears from the literature that even performed alone, SG presents many benefits.

To clarify the role of sleeve gastrectomy in the bariatric procedures range, the investigators propose to conduct a prospective randomized study to compare laparoscopic sleeve gastrectomy to Roux-en-Y gastric bypass.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Morbidly Obese Patients: a Prospective Randomized Clinical Trial
Actual Study Start Date : March 2009
Actual Primary Completion Date : July 2015
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
Experimental: Sleeve gastrectomy
Laparoscopic sleeve gastrectomy
Procedure: Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy

Experimental: Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass
Procedure: Laparoscopic Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass




Primary Outcome Measures :
  1. Excess weight loss at 3 years [ Time Frame: At 36 months ]
    % of excess weight loss

  2. Change in excess weight loss [ Time Frame: At 1, 3, 6, 12, months and every year for 10 years ]
    % of excess weight loss


Secondary Outcome Measures :
  1. Nutritional status and vitamin deficiency [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Albumin

  2. Nutritional status and vitamin deficiency [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Pre-albumin

  3. Nutritional status and vitamin deficiency [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Vitamin A

  4. Nutritional status and vitamin deficiency [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Vitamin D

  5. Nutritional status and vitamin deficiency [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Vitamin B9

  6. Nutritional status and vitamin deficiency [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Vitamin B12

  7. Glycolipid profile [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Fasting plasma glucose

  8. Glycolipid profile [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Serum insulin

  9. Glycolipid profile [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    HbA1c

  10. Glycolipid profile [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Triglycerides

  11. Glycolipid profile [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Cholesterol (total, HDL, LDL)

  12. Quality of life (Moorehead-Ardelt II, Gastro-intestinal Quality of Life Index (GIQLI)) [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Moorehead-Ardelt II, Gastro-intestinal Quality of Life Index (GIQLI)

  13. Pain (visual analog scale) [ Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months ]
    Pain assessment (visual analog scale)



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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:

  • BMI >40 and < 60 kg/m2
  • No contraindication to any of the procedures
  • No contraindication to general anesthesia
  • No known addiction
  • Patient able to provide informed consent

Exclusion Criteria:

  • Contraindication to general anesthesia
  • Known psychiatric pathology
  • Pregnancy
  • Previous major digestive surgery
  • Immunosuppressive treatment including corticoids
  • Coagulopathy (INR>1.5) or platelets < 50 000/µl
  • Anemia (Hb<10g/dl)
  • Severe comorbidity
  • Malabsorptive disease or gastro-intestinal disease
  • Myocardial infarction in previous year, angina, cardiac failure

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): NCT02475590


Locations
France
Service de Chirurgie Digestive et Endocrinienne
Strasbourg, France, 67 000
Sponsors and Collaborators
IHU Strasbourg
IRCAD
Investigators
Principal Investigator: Jacques Marescaux, MD Strasbourg university hospital, IRCAD, IHU Strasbourg

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT02475590     History of Changes
Other Study ID Numbers: 2008-A01590-55
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by IHU Strasbourg:
Sleeve gastrectomy
Roux-en-Y gastric bypass
Excess weight loss
Quality of life

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