A Banded One Anastomosis Gastric Bypass With Use Shape-memory Ring Versus Non-banded One Anastomosis Gastric Bypass (MEMORING)

University Medical Center, Kazakhstan

Status: Withdrawn

Conditions: Obesity

Treatments: Procedure: Laparoscopic one anastomosis gastric bypass; Device: A shape-memory ring for adjustable gastric banding

Study type: Interventional

Funder types: Other

Identifiers

NCT04762849

UMCKazakhstan

Details and patient eligibility

About

Background and study aims:

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). Insufficient weight loss after bariatric surgery or weight gain after surgery is a common big problem in weight loss surgery.

The use of unregulated and uncontrolled bands and rings is not always effective according to previous studies.

This study compares the loss of weight after the laparoscopic banded one anastomosis gastric bypass with the use of a shape-memory ring and standard laparoscopic one anastomosis gastric bypass.

Methods: Adult participants (n=100) are randomly allocated to one of two groups:

Experimental surgical bariatric procedure in the first (A) group: patients (n=50) will undergo the laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) will undergo the laparoscopic one anastomosis gastric bypass (MGB/OAGB group) without band: standard surgery.

All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index.

Full description

This study compares the loss of weight after the laparoscopic banded one anastomosis gastric bypass with the use of a shape-memory ring and standard laparoscopic one anastomosis gastric bypass.

Inclusion Criteria:

• BMI from 30 to 50 kg / m2;
• Ages Eligible for Study: 18 Years to 55 Years

Outcome Measures: Change of body mass index [ Time Frame: Baseline, at 12, 24, 36 months after surgery ]

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of Obesity;
2. BMI from 30 to 50 kg / m2.

Exclusion criteria

1. Insulin-dependent diabetes;
2. BMI less than 30 kg / m2 and more than 50 kg / m2.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR)

Experimental group

Description:

Laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR) include the creation of a gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. A ring with shape memory put on the gastric pouch

Treatment:

Device: A shape-memory ring for adjustable gastric banding

Procedure: Laparoscopic one anastomosis gastric bypass

laparoscopic one anastomosis gastric bypass (MGB/OAGB) without band: standard surgery

Active Comparator group

Description:

Laparoscopic one anastomosis gastric bypass (MGB/OAGB) include the creation of a gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch.

Treatment:

Procedure: Laparoscopic one anastomosis gastric bypass