Pre-operative Very Low-calorie Protein-based Versus Hypocaloric Enteral Nutrition to Improve Intra- and Post-operative Outcomes of Severely Obese Patients Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Surgery duration
研究概览
简要总结
Pre-operative weight loss can reduce the risk intra- and post-operative complications but no optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets (VLCDs) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet. However, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.
详细描述
Bariatric surgery is an important treatment strategy for obese patients having failed multiple diet-induced weight loss attempts. On the other hand, severly obese patients have also a high risk of both intra- and post-operative complications. Pre-operative weight loss can reduce these risks but no optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets (VLCDs) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet. However, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •patient candidate to laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy) after multi-disciplinary pre-operative evaluation
- •Availability to long-term post-operative follow-up
- •Normal kidney function serum creatinine ≤ 1,2 mg/dL and glomerular filtration rate ≥ 90 mL/min
- •Normal liver function (aspartate amino-transferase and/or alanine amino-transferase and/or gamma glutamyl transferase < 2 x N)
- •written informed consent
排除标准
- •age <18 or >60 anni
- •serum creatinine >1,2 mg/dl
- •liver failure (Child-Pugh ≥ A)
- •insuline-dependent diabetes mellitus
- •atrioventricular block with QT > 0,44 ms
- •Cardiac arrythmias
- •Moderate-severe cardiac failure
- •Hypokaliemia
- •Chronic diarrhoea or vomitus
- •12-month previous cardio-vascular disease
- •pregnancy and/or lactation
- •current/previous neoplastic disease
- •psychiatric disorders
- •know gastro-intestinal diseases
- •other controindications to enteral nutrition
- •moderate-severe hypo-albuminemia (<3.0 mg/dL)
- •6-month previous diet-induced weight loss
- •intragastric balloon
- •unavailability to planned measurements
结局指标
主要结局
Surgery duration
时间窗: End of surgery, an expected average of 3.5 hours
from skin incision to wound closure
次要结局
- Composite intra-operative complications(End of surgery, an expected average of 3.5 hours)
- Composite post-operative complications(30 days)
- Intra-operative bleeding(End of surgery, an expected average of 3.5 hours)
- Difficult intubation(Before surgery)
- Time to remove surgical drain(Hospital stay, an avarage of 9 days)
- Total drain fluid production(Hospital stay, an avarage of 9 days)
- Change of multiple biochemical parameters(End of dietary intervention, 28 days)
- Change of multiple anthropometric parameters(End of dietary intervention, 28 days)
- Change in liver fibrosis(End of dietary intervention, 28 days)
- Change in liver volume(End of dietary intervention, 28 days)
- Change in visceral fat(End of dietary intervention, 28 days)
- Change of multiple body composition parameters(End of dietary intervention, 28 days)
- Change in handgrip strength(End of dietary intervention, 28 days)
- Change of multiple cardiac morpho-functional parameters(End of dietary intervention, 28 days)
- Length of hospital stay(Hospital stay, an avarage of 9 days)
- Composite complications of enteral feeding(End of dietary intervention, 28 days)
研究者
Giuseppe Castaldo
Physician
San Giuseppe Moscati Hospital