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Morbid ObesityNCT02475590

Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass

A study testing Laparoscopic sleeve gastrectomy and Laparoscopic Roux-en-Y gastric bypass in people with Morbid Obesity, run by IHU Strasbourg at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Morbid Obesity
What is being tested?
Laparoscopic sleeve gastrectomy and Laparoscopic Roux-en-Y gastric bypass
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteFrance
Study dates
Mar 2009to Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Anemia (Hb<10g/dl)
  • Severe comorbidity
  • Malabsorptive disease or gastro-intestinal disease
  • Myocardial infarction in previous year, angina, cardiac failure

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service de Chirurgie Digestive et Endocrinienne

    Strasbourg, 67 000

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Morbid Obesity
Being tested
Laparoscopic sleeve gastrectomy, Laparoscopic Roux-en-Y gastric bypass
Keywords
Sleeve gastrectomy, Roux-en-Y gastric bypass, Excess weight loss, Quality of life
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic sleeve gastrectomyProcedure or surgery

    Laparoscopic sleeve gastrectomy

  • Laparoscopic Roux-en-Y gastric bypassProcedure or surgery

    Laparoscopic Roux-en-Y gastric bypass

Study groups in NCT02475590
Study groupRoleWhat they receive
Sleeve gastrectomyExperimentalLaparoscopic sleeve gastrectomy
Receives: Procedure: Laparoscopic sleeve gastrectomy
Roux-en-Y gastric bypassExperimentalLaparoscopic Roux-en-Y gastric bypass
Receives: Procedure: Laparoscopic Roux-en-Y gastric bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Excess weight loss at 3 years

    % of excess weight loss

    Measured: At 36 months

  2. Change in excess weight loss

    % of excess weight loss

    Measured: At 1, 3, 6, 12, months and every year for 10 years

Secondary outcomes (13)

  1. Nutritional status and vitamin deficiency

    Albumin

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  2. Nutritional status and vitamin deficiency

    Pre-albumin

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  3. Nutritional status and vitamin deficiency

    Vitamin A

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  4. Nutritional status and vitamin deficiency

    Vitamin D

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  5. Nutritional status and vitamin deficiency

    Vitamin B9

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  6. Nutritional status and vitamin deficiency

    Vitamin B12

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  7. Glycolipid profile

    Fasting plasma glucose

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  8. Glycolipid profile

    Serum insulin

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  9. Glycolipid profile

    HbA1c

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  10. Glycolipid profile

    Triglycerides

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  11. Glycolipid profile

    Cholesterol (total, HDL, LDL)

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  12. Quality of life (Moorehead-Ardelt II, Gastro-intestinal Quality of Life Index (GIQLI))

    Moorehead-Ardelt II, Gastro-intestinal Quality of Life Index (GIQLI)

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

  13. Pain (visual analog scale)

    Pain assessment (visual analog scale)

    Measured: At 1, 3, 6, 12, 18, 24, 30 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2015 (estimated)
  2. Study startMar 2009
  3. Primary completionJul 2015
  4. Study completionJul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02475590
Sponsor's protocol ID
2008-A01590-55
Status last verified
Feb 2018
First submitted
26 May 2015
Last updated
28 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • Vix M, Liu KH, Diana M, D'Urso A, Mutter D, Marescaux J. Impact of Roux-en-Y gastric bypass versus sleeve gastrectomy on vitamin D metabolism: short-term results from a prospective randomized clinical trial. Surg Endosc. 2014 Mar;28(3):821-6. doi: 10.1007/s00464-013-3276-x. Epub 2013 Nov 7.

    PubMed 24196556

  • Vix M, Diana M, Liu KH, D'Urso A, Mutter D, Wu HS, Marescaux J. Evolution of glycolipid profile after sleeve gastrectomy vs. Roux-en-Y gastric bypass: results of a prospective randomized clinical trial. Obes Surg. 2013 May;23(5):613-21. doi: 10.1007/s11695-012-0827-5.

    PubMed 23207829

  • Ignat M, Vix M, Imad I, D'Urso A, Perretta S, Marescaux J, Mutter D. Randomized trial of Roux-en-Y gastric bypass versus sleeve gastrectomy in achieving excess weight loss. Br J Surg. 2017 Feb;104(3):248-256. doi: 10.1002/bjs.10400. Epub 2016 Nov 30.

    PubMed 27901287

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic sleeve gastrectomy and Laparoscopic Roux-en-Y gastric bypass in people with Morbid Obesity, run by IHU Strasbourg at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Excess weight loss at 3 years (time frame: At 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02475590, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.

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