Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prospective Randomized Study of Effects of Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy
Brief Summary: The sleeve gastrectomy that has been utilized as a first-stage bariatric procedure to reduce surgical risk in high-risk patients by induction of weight loss is now gaining popularity as a standalone procedure for the treatment of morbid obesity. It appears to be a technically easier and/or faster laparoscopic procedure than Roux-en-Y gastric bypass. It brings good weight loss results, in some studies even comparable to the RYGB and Biliopancreatic Diversion with Duodenal Switch.

The mechanism of action is assumed to be purely restrictive, but some neurohumoral interaction may exist. Almost no data exist on the influence of the sleeve gastrectomy on the medical and general quality of life or resolution of comorbidities.

The rates of the comorbidities resolution 12 to 24 months after sleeve gastrectomy has been reported in the range that seems to be higher than for the purely restrictive procedures.

Our goal is to to compare the surgical and weight loss outcomes between the two procedures, their influence on resolution of common comorbidities and on quality of life change.

150 eligible candidates will be randomized into two groups, one will undergo Laparoscopic Sleeve Gastrectomy, the other will have Laparoscopic Roux-en-Y Gastric Bypass done. Detailed evaluation and preoperative questionnaires will be used to obtain demographic and medical data, and quality of life will be assessed.

General metabolic and nutritional work up will be done, and will be reassessed at different intervals up to 5 years, in order to compare the short and long term results of the two procedures.


Options:
A: Arm Label: 1; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: gastric bypass | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Procedure: sleeve gastrectomy | Intervention Type: PROCEDURE; Name: gastric bypass; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: sleeve gastrectomy; Assigned to Arm(s): 3
B: Arm Label: Bariatric surgery; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Bariatric surgery | Arm Label: Intensive lifestyle intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Intensive lifestyle intervention | Intervention Type: PROCEDURE; Name: Bariatric surgery; Assigned to Arm(s): Bariatric surgery | Intervention Type: BEHAVIORAL; Name: Intensive lifestyle intervention; Assigned to Arm(s): Intensive lifestyle intervention
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: laparoscopic operation Sleeve Gastrectomy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: laparoscopic operation Roux-en-Y Gastric bypass | Intervention Type: PROCEDURE; Name: laparoscopic operation Sleeve Gastrectomy; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: laparoscopic operation Roux-en-Y Gastric bypass; Assigned to Arm(s): 2
D: Arm Label: EndoBarrier Device; Type: EXPERIMENTAL; Interventions: Device: EndoBarrier Device, Behavioral: Diet & Lifestyle Counseling | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Diet & Lifestyle Counseling | Intervention Type: DEVICE; Name: EndoBarrier Device; Assigned to Arm(s): EndoBarrier Device | Intervention Type: BEHAVIORAL; Name: Diet & Lifestyle Counseling; Assigned to Arm(s): Control, EndoBarrier Device

Answer: C