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Currently, one anastomosis gastric bypass (OAGB) or mini-gastric bypass (MGB) is a common bariatric procedure for treating obesity. Weight gain after surgery is a big problem in bariatric practice. Therefore, adjustable bands and rings are used, for example, "FobiRing". But foreign material can cause complications - the erosion of the stomach wall. For this reason, surgeons avoid the use of various mechanical devices on living tissues.
The greatest criticism is of the OAGB for the likelihood of biliary reflux. In case of reflux of bile into the esophagus after surgery, as a rule, a second operation is required with conversion OAGB to the Roux-en-Y method.
In addition, along with obesity, gastroesophageal reflux disease (GERD) are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. In these cases, most often in bariatric practice, 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 significant prevent the return of weight like after a banded gastric bypass and prevent postoperative bile reflux in the esophagus.
The aim study is to compare primary outcome as weight loss after total wrapping of the fundus of the gastric excluded part (FundoRing) and non - wrapping (non - banded) standard method of laparoscopic one anastomosis gastric bypass and measure secondary outcome: bile reflux in the esophagus and GERD symptoms.
Methods: Adult participants (n=1000) are randomly allocated to one of two groups:
Experimental surgical bariatric procedure in the first (A) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty if present hiatal hernia (FundoRingOAGB group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass and with only suture cruroplasty if present hiatal hernia (OAGB group).
One anastomosis Gastric Bypass/Mini Gastric Bypass (OAGB/MGB) is gaining popularity as a primary surgical treatment for morbid obesity.
The aim study is to compare primary outcome as weight loss after total wrapping of the fundus of the gastric excluded part (FundoRing) and non - wrapping (non - banded) standard method of laparoscopic one anastomosis gastric bypass and measure secondary outcome: bile reflux in the esophagus and GERD symptoms.
Methods: Adult participants (n=1000) are randomly allocated to one of two groups:
Experimental surgical bariatric procedure in the first (A) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty if present hiatal hernia (FundoRingOAGB group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass and with only suture cruroplasty if present hiatal hernia (OAGB group). All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index and and measure secondary outcome: bile reflux in the esophagus and GERD symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FundoRingOAGB group | Experimental | laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part (and suture cruroplasty if present hiatal hernia). |
|
| OAGB group | Active Comparator | laparoscopic one anastomosis gastric bypass (and suture cruroplasty if present hiatal hernia). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FundoRingOAGB | Procedure | laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and with suture cruroplasty if present hiatal hernia |
| Measure | Description | Time Frame |
|---|---|---|
| Change of body mass index | The measure is assessing a change of body mass index (kg/m2) in groups . 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, 60 months after surgery |
| Number of participants with bile reflux in esophagus | Endoscopic assessment of bile reflux in esophagus and 24-hour pH-impedance monitoring to detect number of postoperative esophageal bile reflux (non-acid reflux) in in each group | at 12, 24, 36 months after surgery |
| Number of participants with GERD symptoms | Change of GERD symptoms (use GERD Health-related Quality of Life (GERD-HRQL) Questionnaire) if present GERD or number of participants with postoperative de Novo GERD. Scoring Scale 0 = No symptoms
| Baseline, 12, 24, 36 months after surgery |
| Frequency of late (>30 day) postoperative complication in each groups | Namber participants with late postoperative complication ( dumping syndrome, marginal ulcer, food intolerance, protein malnutrition, anemia, thiamine deficiency) | >30 days, at 12, 24, 36 months after surgery |
| Chance of the components of Metabolic Syndrome (MetS) after surgery | Chance of level of HbA1c (<5,7%), level of HOMA-IR (<2.7) , < number participants with type 2 diabetes and arterial hypertension and chanqe of Lipid profile (Total Cholesterol: <200 mg/dL, LDL Cholesterol: <100 mg/dL (optimal), HDL Cholesterol: >60 mg/dL (desirable), Triglycerides: <150 mg/dL) at 1 and 3-year follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral glucose tolerance tests | A standard 3-hour oral glucose tolerance tests performs using 75 g glucose | Blood samples for glucose collects at 0, 15, 30, 60, 120, 150 and 180 minutes, while those for insulin collects at 0, 30, 60, 120 and 180 minutes |
| Sigstad score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oral Ospanov | President of Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Ospanov | Astana | 010000 | Kazakhstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35392958 | Result | Ospanov O, Yeleuov G, Fursov A, Yelembayev B, Fursov R, Sergazin Z, Mustafin A. A laparoscopic one anastomosis gastric bypass with wrapping versus nonwrapping fundus of the excluded part of the stomach to treat obese patients (FundoRingOAGB trial): study protocol for a randomized controlled trial. Trials. 2022 Apr 7;23(1):264. doi: 10.1186/s13063-022-06252-6. | |
| 36800158 |
| Label | URL |
|---|---|
| A laparoscopic one anastomosis gastric bypass with wrapping versus nonwrapping fundus of the excluded part of the stomach to treat obese patients (FundoRingOAGB trial): study protocol for a randomized controlled trial | View source |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| OAGB | Procedure | laparoscopic one anastomosis gastric bypass with suture cruroplasty if present hiatal hernia |
|
| baseline, 1 and 3-year follow-up |
| Cases of recurrent weight gain (The percentage total weight loss (%TWL) lower than 35%) | Maintenance of a weight loss of 35% or more after weight loss surgery at 5 years was classified as superior weight loss (no significant weight regain). Patients with a weight loss of less than 35% at 60 months after surgery were classified as having weight regain (recurence). For comparison with earlier studies, the percentage of excess weight loss (%EWL) was also calculated for each time point using the following formula: (baseline weight - weight at follow-up)/(baseline weight - ideal body weight) × 100. Ideal body weight was set at a BMI of 25, resulting in the following formula: weight (kg) = 25 × height (m)². | 60 months after surgery |
Sigstad score for questionnaire of diagnostic the dumping syndrome. The Sigstad score is a diagnostic index for dumping syndrome, with a score >7 indicating a high probability of the condition, while a score < 4 suggests alternative diagnoses. Key Elements of the Sigstad Scoring System:
|
| 6, 12, 24, 36 months after surgery |
| Ospanov O. The Surgical Technique of Primary Modified Fundoplication Using the Excluded Stomach with Simultaneous Gastric Bypass. Obes Surg. 2023 Apr;33(4):1311-1313. doi: 10.1007/s11695-023-06505-6. Epub 2023 Feb 17. |
| 37099252 | Result | Ospanov O, Yeleuov G, Buchwald JN, Zharov N, Yelembayev B, Sultanov K. A Randomized Controlled Trial of Acid and Bile Reflux Esophagitis Prevention by Modified Fundoplication of the Excluded Stomach in One-Anastomosis Gastric Bypass: 1-Year Results of the FundoRing Trial. Obes Surg. 2023 Jul;33(7):1974-1983. doi: 10.1007/s11695-023-06618-y. Epub 2023 Apr 26. |
| 41331600 | Derived | Ospanov O, Yelembayev B, Buchwald JN, Sultanov K, Rakhmetov M, Duysenov G, Tuleuov B. Comparative endoscopic ultrasound assessment of the gastric pouch after FundoRing-OAGB and OAGB. BMC Surg. 2025 Dec 2;26(1):23. doi: 10.1186/s12893-025-03386-7. |
| 34059995 | Derived | Ospanov OB. The Gastric Bypass and Fundoplication in Bariatric Surgery: the Comments on Published Papers and Our Classification of Combination Procedures. Obes Surg. 2021 Oct;31(10):4643-4644. doi: 10.1007/s11695-021-05505-8. Epub 2021 Jun 1. |
| The Surgical Technique of Primary Modified Fundoplication Using the Excluded Stomach with Simultaneous Gastric Bypass | View source |
| A Randomized Controlled Trial of Acid and Bile Reflux Esophagitis Prevention by Modified Fundoplication of the Excluded Stomach in One-Anastomosis Gastric Bypass: 1-Year Results of the FundoRing Trial | View source |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |