Clinical trial NCT04762849: A Banded One Anastomosis Gastric Bypass With Use Shape-memory Ring Versus Non-banded One Anastomosis Gastric Bypass
Official title: A Randomized Clinical Trial of Banded One Anastomosis Gastric Bypass With Use Shape-memory Ring Versus Non-banded One Anastomosis Gastric Bypass
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Bariatric surgery
Ring with shape memory
One anastomosis gastric bypass
Lead sponsor: University Medical Center, Kazakhstan
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly allocated to one of two groups:

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

Brief summary: 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.

Detailed 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 \[ Time Frame: Baseline, at 12, 24, 36 months after surgery \]

Eligibility criteria: 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.

Primary outcomes:
measure: Change of body mass index
timeFrame: Baseline, at 12, 24, 36 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: University medical center
Study officials:
affiliation: Corporate Foundation "University Medical Center" (UMC)
name: Oral Ospanov, Professor
role: PRINCIPAL_INVESTIGATOR
References: