A Banded One Anastomosis Gastric Bypass With Use Shape-memory Ring Versus Non-banded One Anastomosis Gastric Bypass
NCT ID: NCT04762849
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-04-01
2024-05-01
Brief Summary
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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.
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Detailed Description
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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 \[ Time Frame: Baseline, at 12, 24, 36 months after surgery \]
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR)
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
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.
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.
laparoscopic one anastomosis gastric bypass (MGB/OAGB) without band: standard surgery
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. BMI from 30 to 50 kg / m2.
Exclusion Criteria
2. BMI less than 30 kg / m2 and more than 50 kg / m2.
18 Years
60 Years
ALL
No
Sponsors
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University Medical Center, Kazakhstan
OTHER
Responsible Party
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Oral Ospanov
Professor Oral Ospanov
Principal Investigators
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Oral Ospanov, Professor
Role: PRINCIPAL_INVESTIGATOR
Corporate Foundation "University Medical Center" (UMC)
Locations
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University medical center
Astana, , Kazakhstan
Countries
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Other Identifiers
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UMCKazakhstan
Identifier Type: -
Identifier Source: org_study_id
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