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

Obesity Clinical Trial

— MEMORING  

Official title:

A Randomized Clinical Trial of Banded One Anastomosis Gastric Bypass With Use Shape-memory Ring Versus Non-banded One Anastomosis Gastric Bypass

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04762849
• Other study ID #: UMCKazakhstan
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: University Medical Center, Kazakhstan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 ]

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Laparoscopic one anastomosis gastric bypass
Laparoscopic one anastomosis gastric bypass include the creation of gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. For the creation of a gastric pouch and gastroenterostomy use a linear stapler.

Device:
• A shape-memory ring for adjustable gastric banding
A shape-memory ring (SMR) use for adjustable gastric banding. SMR is placed around the gastric pouch above the gastro-entero-anastomosis.

Locations

Country	Name	City	State
Kazakhstan	University medical center	Astana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center, Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of body mass index	The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2.	Baseline, at 12, 24, 36 months after surgery