The Total Wrapping of the Fundus of the Gastric Excluded Part (FundoRing) Versus Non- Wrapping (Non-banded) Standard Method of Laparoscopic One Anastomosis Gastric Bypass/Mini - Gastric Bypass: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change of body mass index
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI from 30 to 50 kg / m
- •The person is generally fit for anesthesia (ASA grading 1-2) and surgery.
- •The person commits to the need for long-term follow-up.
排除标准
- •BMI less than 30 kg / m2 and more than 50 kg / m
- •Prosthetic (mesh) Hiatal herniorrhaphy or large hiatal hernia;
- •Esophageal shortening
- •Los Angeles Classification of Oesophagitis (LA grade) C or D reflux esophagitis
- •History of surgery on the stomach or esophagus
- •Less than 18 or more than 60 years of age
- •Not fit for bariatric surgery
- •Psychiatric illness
- •Patients unwilling or unable to provide informed consent
研究组 & 干预措施
FundoRingOAGB group
laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part (and suture cruroplasty if present hiatal hernia).
干预措施: FundoRingOAGB (Procedure)
OAGB group
laparoscopic one anastomosis gastric bypass (and suture cruroplasty if present hiatal hernia).
干预措施: OAGB (Procedure)
结局指标
主要结局
Change of body mass index
时间窗: Baseline, at 12, 24, 36, 60 months after surgery
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.
Cases of recurrent weight gain (The percentage total weight loss (%TWL) lower than 35%)
时间窗: 60 months after surgery
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.
Change of body mass index
时间窗: Baseline, at 12, 24, 36 months after surgery
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.
Number of participants with bile reflux in esophagus
时间窗: at 12, 24, 36 months after surgery
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
Number of participants with GERD symptoms
时间窗: Baseline, 12, 24, 36 months after surgery
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 1. = Symptoms noticeable but not bothersome 2. = Symptoms noticeable and bothersome but not every day 3. = Symptoms bothersome every day 4. = Symptoms affect daily activities 5. = Symptoms are incapacitating - unable to do daily activities
Frequency of late (>30 day) postoperative complication in each groups
时间窗: >30 days, at 12, 24, 36 months after surgery
Namber participants with late postoperative complication ( dumping syndrome, marginal ulcer, food intolerance, protein malnutrition, anemia, thiamine deficiency)
Chance of the components of Metabolic Syndrome (MetS) after surgery
时间窗: baseline, 1 and 3-year follow-up
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.
次要结局
- Oral glucose tolerance tests(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(6, 12, 24, 36 months after surgery)