Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass

February 27, 2018 updated by: IHU Strasbourg

Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Morbidly Obese Patients: a Prospective Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67 000
        • Service de Chirurgie Digestive et Endocrinienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Excess weight loss at 3 years
Time Frame: At 36 months
% of excess weight loss
At 36 months
Change in excess weight loss
Time Frame: At 1, 3, 6, 12, months and every year for 10 years
% of excess weight loss
At 1, 3, 6, 12, months and every year for 10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nutritional status and vitamin deficiency
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Albumin
At 1, 3, 6, 12, 18, 24, 30 and 36 months
Nutritional status and vitamin deficiency
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Pre-albumin
At 1, 3, 6, 12, 18, 24, 30 and 36 months
Nutritional status and vitamin deficiency
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Vitamin A
At 1, 3, 6, 12, 18, 24, 30 and 36 months
Nutritional status and vitamin deficiency
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Vitamin D
At 1, 3, 6, 12, 18, 24, 30 and 36 months
Nutritional status and vitamin deficiency
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Vitamin B9
At 1, 3, 6, 12, 18, 24, 30 and 36 months
Nutritional status and vitamin deficiency
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Vitamin B12
At 1, 3, 6, 12, 18, 24, 30 and 36 months
Glycolipid profile
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Fasting plasma glucose
At 1, 3, 6, 12, 18, 24, 30 and 36 months
Glycolipid profile
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Serum insulin
At 1, 3, 6, 12, 18, 24, 30 and 36 months
Glycolipid profile
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
HbA1c
At 1, 3, 6, 12, 18, 24, 30 and 36 months
Glycolipid profile
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Triglycerides
At 1, 3, 6, 12, 18, 24, 30 and 36 months
Glycolipid profile
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Cholesterol (total, HDL, LDL)
At 1, 3, 6, 12, 18, 24, 30 and 36 months
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)
At 1, 3, 6, 12, 18, 24, 30 and 36 months
Pain (visual analog scale)
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Pain assessment (visual analog scale)
At 1, 3, 6, 12, 18, 24, 30 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IHU Strasbourg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IRCAD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacques Marescaux, MD, Strasbourg university hospital, IRCAD, IHU Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2008-A01590-55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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