Changes in Lipid Indices and Body Composition One Year After Laparoscopic Gastrectomy: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in body composition (changes in lean tissue mass and fatty tissue mass Using DEXA machine produced by Hologic)
研究概览
简要总结
Nutritional status including changes of body composition is one of the most important clinical determinants of outcome after gastrectomy for gastric cancer. Various type of gastric operations are widely used with favorable outcome in South Korea. It was reported that several advantages of laparoscopic gastrectomy are the prevention of overt weight loss and enhanced recovery of muscle mass at 6 months after surgery. But there have been no longitudinal studies evaluating changes in the body composition according to the different type of anastomosis of laparoscopic gastrectomy.
The purpose of this prospective study was to investigate changes in lipid indices associated with whole body composition during 1 year of follow-up after laparoscopic gastrectomy. Gastrectomy resulted in improved lipid indices and a reduction in body weight, fat and LBM. The HDL-Csignificantly increased in the non-obese group for 1 year after gastrectomy and the reduction of TG level was positively correlated with fat, especially with trunk fat.
详细描述
- All patients will undergo a laparoscopic gastrectomy for their gastric cancer (proved to be stage I or II) or benign gastric neoplasm by preoperative screening diagnostic procedure. They will receive laparoscopic gastrectomy as follows: (1) wedge resection, subtotal or total gastrectomy with or without lymph node dissection; (2) R0 resection; (3) laparoscopic gastrectomy; (4 gastroduodenal anastomosis or duodenal bypass, including Roux-en-Y or gastrojejunostomy.
- Pre-operative, 6 and 12 months post-operative body composition measurement will be performed on each patient. The whole body composition measurement will be assessed by Hologic 4500/A dual energy X-ray absorptiometry system. The software performs calculations of the differential attenuations of the two photon energies and present data of percentage of fat, fat mass (g), lean mass (g), bone mineral content (g), bone mineral density (g/cm2), and total mass (g).
- Laboratory analysis - There is a battery of labs that are ordered in both the pre-operative, 6 and 12 months post-operative time frame. These labs are ordered independent of the patient's participation in the study. These labs are ordered to evaluate and to assist management of the patient's medical comorbidities as well as to assess for adequate nutritional intake and balance.
- Queries on nutritional intake and exercise will be made at each post-operative appointment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with gastric cancer or benign gastric neoplasm planning gastric operation
- •Stage I and II patients by preoperative screening
排除标准
- •Distant metastasis
- •Severe comorbidity
- •Malnourished state
- •Inability of access to enteral feeding
研究组 & 干预措施
Non-Obese
Patients who underwent laparoscopic gastrectomy and with BMI < 25 kg/m2
干预措施: Laparoscopic gastrectomy (Procedure)
Obese
Patients who underwent laparoscopic gastrectomy and with BMI ≥ 25 kg/m2
干预措施: Laparoscopic gastrectomy (Procedure)
结局指标
主要结局
Change in body composition (changes in lean tissue mass and fatty tissue mass Using DEXA machine produced by Hologic)
时间窗: pre-surgery, 6 and 12 months post-surgery
Using DEXA machine produced by Hologic (QDR 4500), changes in lean tissue mass and fatty tissue mass following gastric operation assessed
次要结局
- Changes in lipid profile(pre-surgery, 6 and 12 months post-surgery)
研究者
Ji Young Kim
Clinical Professor
Hanyang University Seoul Hospital