The Effect of Visceral Fat Removal for Gastric Cancer Patients With Metabolic Syndrome, Randomized Pilot Study: Omentectomy for Metabolic Syndrome (OMS)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- HOMA-IR change
研究概览
简要总结
Many features of the metabolic syndrome are associated with insulin resistance. And, metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the investigators hypothesized that visceral fat removal (omentectomy) can make favorable results for the insulin resistance and metabolic syndrome. As the omentectomy is optional procedure during a surgery for early gastric cancer, the investigators will divide patients randomly into two groups, total omentectomy group and omentum preserving group.
详细描述
The investigators will compare the change of insulin resistance (HOMA-IR) and improvement of metabolic syndrome between total omentectomy and omentum preserving 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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma in stomach
- •Aged≥20 years and ≤80 years
- •Scheduled as laparoscopic distal gastrectomy (cT1N0M0 or cT2N0M0)
- •Metabolic syndrome (NCEP:ATP III (National Cholesterol Education Program and Adult Treatment Panel III) -harmonizing definition criteria
- •ECOG 0 (Eastern Cooperative Oncology Group)
- •ASA score class I-III (American Society of Anesthesiologists)
- •patient has given their written informed consent to participate in the study
排除标准
- •Simultaneously combined resection of other organ
- •Active other malignancy
- •Expected to severe intra-abdominal adhesion due to previous abdominal operation history
- •Uncontrolled co-morbidity
- •Vulnerable patients
研究组 & 干预措施
Omentum preserving
Omentum preserving: The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed.
干预措施: Omentum preserving (Procedure)
Total omentectomy
Total omentectomy: Whole omentum will be removed.
干预措施: Total omentectomy (Procedure)
结局指标
主要结局
HOMA-IR change
时间窗: pre-operative and post-operative 12months
HOMA-IR change after operation
次要结局
- Complication(within 30days)
- prevalence of metabolic syndrome(pre-operative and post-operative 12months)
- HOMA-IR change according to anastomosis type(pre-operative and post-operative 12months)
研究者
Seung Wan Ryu
Director of Gastrointesinal surgery, associate professor
Keimyung University Dongsan Medical Center