Conversion of Failed Sleeve Gastrectomy Due to Weight Regain to SADI-S, RYGB or OAGB
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- somscore of food tolerance
研究概览
简要总结
Assess what revisional surgery is superior and provides the best weight loss after primary LSG. What is the occurrence of complications and the nutritional laboratory status? And if the resolution and /or improvement of associated medical problems after the weight loss will occur.
详细描述
Laparoscopic sleeve gastrectomy (LSG) gained popularity and has become one of the most performed weight loss procedures worldwide. In the long-term follow-up, the literature states that the incidence of gastroesophageal reflux disease (GERD) accounts for 16%, and weight regains accounting for 70% after LSG. These are the two most common complications which can necessitate further surgical intervention.
The hypotheses are that laparoscopic conversion from LSG to Single anastomosis duodeno-ileal bypass (SADI-S), Roux-en-Y gastric bypass (RYGB), or one anastomosis gastric bypass (OAGB) will provide a new significant weight loss, improvement in obesity-related health problems and provide no nutritional deficiency in all cases.
Since the three types of procedures have other anatomical presentations, whereby these is not well tested next to each other in a blinded, controlled setting for the patient, this study is designed to discover if the procedures are superior to each other or not and what the best outcome is for the patient.
A sample size is calculated and with a medium effect size of 0.5 corresponds to a mean difference in %EBMIL between SADI-S, RYGB, and OAGB of at least 10%. Using a power of 0.8 with an alpha of 0.05 resulted in a sample size of 64 patients per group.
Considering a possible loss of patients to follow-up, an additional 20% increase in sample size was included per group, resulting in a minimum of 78 patients per group.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergone primary laparoscopic sleeve gastrectomy in the past
- •Weight regain
- •defined as any increase in weight above the nadir as reported by the patient
- •BMI at the time of revisional surgery was around 45 kg/m2
- •weight regain was defined as an increase in BMI after bariatric surgery to exceed 35
- •With or without Gastroesophageal reflux disease (GERD) grade A and B o Patients with grade C or higher GERD, according to the Los Angeles (LA) classification [7] will be excluded from the study
排除标准
- •Didn't follow preoperative consultation
- •Cannot give of sign informed consent
结局指标
主要结局
somscore of food tolerance
时间窗: 2,6 weeks and 3,6,12,24 months
validated food tolerance questions: Food tolerance (FT) was evaluated using a one-page questionnaire divided into 4 sections, 3 of which were used to calculate the score: overall patient satisfaction with eating (score: 1-5); tolerability to certain food types (score: 0-16); and frequency of vomiting/regurgitation (score: 0-6), with a total score between 1 and 27; higher scores indicate better food tolerance
The number of participants who will have early complications related to surgery
时间窗: 6 weeks
the incidence of re-operation, bleeding or leakages
The percentage Excess body weight loss (%EWL)
时间窗: 3,6,12,24 months
the amount of weight loss after revision surgery
次要结局
- Incidence of Reflux(3,6,12,24 months)
- Metabolic biomarkers Peptide YY ( PYY)(3,6,12,24 months)
- Nutritional levels of proteinemia(3,6,12,24 months)
- Metabolic biomarkers Glucagon-like peptide-1 (GLP1)(3,6,12,24 months)
- Metabolic biomarkers Leptin(3,6,12,24 months)
- Metabolic biomarkers Ghrelin(3,6,12,24 months)
- VAS/NRS (incidence of pain)(3,6,12,24 months)
- Metabolic biomarkers Insulin(3,6,12,24 months)
- Nutritional levels of albuminemia(3,6,12,24 months)
- Nutritional levels of anemia(3,6,12,24 months)
- Nutritional levels of calcemic(3,6,12,24 months)
- The number of participants who will have late complications related to surgery(3,6,12,24 months)
- Short Form 36 Quality of life(3,6,12,24 months)
研究者
Mohamed Hany Ashour
ass professor
General Committee of Teaching Hospitals and Institutes, Egypt