Laparoscopic Gastric Bypass With the Total Wrapping of the Fundus of Gastric Excluded Part for Treating Obesity and GERD
Study Details
Study Description
Brief Summary
Background and study aims:
Currently, one anastomosis Gastric Bypass/Mini Gastric Bypass (OAGB/MGB) is a common bariatric procedure.
Obesity and gastroesophageal reflux disease are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. In these cases, most often, hiatus cruroraphy is performed, and less often fundoplication using the fundus of the excluded part of the stomach. We hypothesize that total fundoplication can not only treat GERD but also prevent the return of weight like a banded gastric bypass.
The aim study is to compare bariatric and antireflux results after OAGB/MGB plus suture cruroplasty (SCP) with and without total fundoplication.
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) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty (OAGB + SCP + TF group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with only suture cruroplasty (OAGB + SCP group). All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index and change of GERD symptoms (GERD-HRQL).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
One anastomosis Gastric Bypass/Mini Gastric Bypass (OAGB/MGB) is gaining popularity as a primary surgical treatment for morbid obesity. The total fundoplication is the gold standard for treating GERD. Morbid obesity and GERD require simultaneous surgical treatment. We hypothesize that total fundoplication can not only treat GERD but also prevent the return of weight like a banded gastric bypass.
The aim study is to compare bariatric and antireflux results after OAGB/MGB plus suture cruroplasty (SCP) with and without total fundoplication.
Adult participants (n=100) are randomly allocated to one of two groups:
Experimental surgical bariatric procedure in the first (A) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty (OAGB + SCP + TF group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with only suture cruroplasty (OAGB + SCP group). All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index and change of GERD symptoms (GERD-HRQL).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Antireflux OAGB group Antireflux laparoscopic one anastomosis gastric bypass with suture cruroplasty and the total wrapping of the fundus of the gastric excluded part. |
Procedure: Antireflux laparoscopic one anastomosis gastric bypass
Laparoscopic gastric bypass with suture cruroplasty and total wrapping of the fundus of gastric excluded part.
|
| Active Comparator: Standard OAGB group laparoscopic one anastomosis gastric bypass with only suture cruroplasty. |
Procedure: Standard laparoscopic one anastomosis gastric bypass
laparoscopic gastric bypass with only suture cruroplasty. Not used fundoplication.
|
Outcome Measures
Primary Outcome Measures
- Change of body mass index [Baseline, at 12, 24, 36 months after surgery]
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.
- Change of GERD symptoms (GERD-HRQL) [12, 24, 36 months after surgery]
Success; ≥50% improvement in the baseline GERD-HRQL score Failure; <50% improvement in the baseline GERD-HRQL score at 12,24, 36 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
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BMI from 30 to 50 kg / m2.
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Gastroesophageal reflux diseases
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The person is generally fit for anesthesia (ASA grading 1-2) and surgery.
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The person commits to the need for long-term follow-up.
Exclusion Criteria:
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BMI less than 30 kg / m2 and more than 50 kg / m2.
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Prosthetic (mesh) hiatal herniorrhaphy or large hiatal hernia;
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Esophageal shortening
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Los Angeles Classification of Oesophagitis (LA grade) C or D reflux esophagitis
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History of surgery on the stomach or esophagus
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Less than 18 or more than 60 years of age
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Not fit for bariatric surgery
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Psychiatric illness
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Patients unwilling or unable to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oral Ospanov | Astana | Kazakhstan | 020000 |
Sponsors and Collaborators
- The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Investigators
- Principal Investigator: Oral Ospanov, Professor, President of Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OAGB/FUNDO