Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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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

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sleeve gastrectomy

Laparoscopic sleeve gastrectomy

Group Type EXPERIMENTAL

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Laparoscopic sleeve gastrectomy

Roux-en-Y gastric bypass

Laparoscopic Roux-en-Y gastric bypass

Group Type EXPERIMENTAL

Laparoscopic Roux-en-Y gastric bypass

Intervention Type PROCEDURE

Laparoscopic Roux-en-Y gastric bypass

Interventions

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Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Laparoscopic Roux-en-Y gastric bypass

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No