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

NCT04762849 | Withdrawn

• 1 other identifier: UMCKazakhstan
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Bariatric surgery; Ring with shape memory; One anastomosis gastric bypass

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

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

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

ACTIVE COMPARATOR

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.

Procedure: Laparoscopic one anastomosis gastric bypass

Interventions

Laparoscopic one anastomosis gastric bypass PROCEDURE

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.

laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR); laparoscopic one anastomosis gastric bypass (MGB/OAGB) without band: standard surgery

A shape-memory ring for adjustable gastric banding DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center, Kazakhstan: lead

Study Sites (1)

University medical center

Astana, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oral Ospanov, Professor

  Corporate Foundation "University Medical Center" (UMC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Oral Ospanov

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 21, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)