Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Study of Life Expectancy in Patients With Metabolic Syndrome After Weight Loss: a Comparative Randomized Clinical Trial
Brief Summary: Background and study aims:

Surgical and non-surgical normalization of body weight with obesity leads to a significant improvement in health and regression of metabolic syndrome. But as the reduction in body weight with obesity changes the life expectancy remains not clear enough.

The use of endoscopic staplers does not exclude the emergence of serious complications of surgery, for example, including bleeding and leakage in the stapler suture line. Therefore, the advantages of using a band in the bariatrics are justified from a security standpoint.

Currently, the gastric bypass is increasingly performed in the version of the mini gastric bypass (MGB). Another name for the procedure: one anastomosis gastric bypass (OAGB). The proposal to use for the staple-free (stepleless or steplerless) creation of a pouch (band-separated gastric bypass) with use for band a vascular prosthesis is justified, but it requires comparison of this method with a stapler variant.

An important issue is comparing surgical and non-surgical weight loss with obesity and metabolic syndrome and comparing life expectancy with confirmation of changes in telomere length.

This study compares loss of weight, changes in other health conditions that the patient may have (co-morbidities, such as diabetes), telomere length, quality of life, the number of complications and side effects, the degree of complexity of the surgical technique and operating costs of a new laparoscopic band-separated mini- gastric bypass (LBSMGB) procedure compared with the standard stapler (linear cutter) - separated mini-gastric bypass (LSSMGB). Additionally, surgical treatment will be compared with non-surgical treatment (hypocaloric diet therapy).

Who can participate? Obese adult patients with a BMI of between 30 kg/m2 and 50 kg/m2. What does the study involve? Participants are randomly allocated to one of three groups. Those in the first (A) group undergo the laparoscopic band-separated mini-gastric bypass procedure. Those in the second (B) group undergo the linear cutter stapler-separated mini-gastric bypass procedure. In three (C) group including standard lifestyle intervention on weight and hypocaloric diet therapy.

All patients are then followed up one month after surgery and again after 6 and, finally, 12 months after surgery where the changing body mass index, changes in co-morbidities, change telomere length and quality of life are assessed.


Options:
A: Arm Label: Treatment group; Type: ACTIVE_COMPARATOR; Interventions: Device: placement of g-Cath EZ suture anchors, Behavioral: Diet and Exercise | Arm Label: Sham Group; Type: SHAM_COMPARATOR; Interventions: Procedure: Sham procedure, Behavioral: Diet and Exercise | Intervention Type: DEVICE; Name: placement of g-Cath EZ suture anchors; Assigned to Arm(s): Treatment group | Intervention Type: PROCEDURE; Name: Sham procedure; Assigned to Arm(s): Sham Group | Intervention Type: BEHAVIORAL; Name: Diet and Exercise; Assigned to Arm(s): Sham Group, Treatment group
B: N/A
C: Arm Label: Stapleless one anastomosis gastric bypass; Type: EXPERIMENTAL; Interventions: Procedure: Laparoscopic one anastomosis gastric bypass | Arm Label: Staple use mini-gastric bypass; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Laparoscopic one anastomosis gastric bypass | Arm Label: Hypocaloric diet therapy; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Hypocaloric diet therapy | Intervention Type: PROCEDURE; Name: Laparoscopic one anastomosis gastric bypass; Assigned to Arm(s): Staple use mini-gastric bypass, Stapleless one anastomosis gastric bypass | Intervention Type: DIETARY_SUPPLEMENT; Name: Hypocaloric diet therapy; Assigned to Arm(s): Hypocaloric diet therapy
D: Arm Label: Laparoscopic Roux-en-Y gastric bypass; Type: EXPERIMENTAL; Interventions: Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB), Other: Clinical treatment | Arm Label: Clinical treatment; Type: ACTIVE_COMPARATOR; Interventions: Other: Clinical treatment | Intervention Type: PROCEDURE; Name: Laparoscopic Roux-en-Y gastric bypass (LRYGB); Assigned to Arm(s): Laparoscopic Roux-en-Y gastric bypass | Intervention Type: OTHER; Name: Clinical treatment; Assigned to Arm(s): Clinical treatment, Laparoscopic Roux-en-Y gastric bypass

Answer: C