Postoperative Pain and Quality of Life After Single-incision Distal Gastrectomy Versus Totally Laparoscopic Distal Gastrectomy for Early Gastric Cancer - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Maximum pain score using VAS at postoperative day#1
研究概览
简要总结
- Compare the immune response and postoperative complications between pure SIDG (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal gastrectomy) for early gastric cancer (EGC)
- Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC)
详细描述
There are some trends of reducing the numbers and lengths of wounds in the fields of laparoscopic surgery.
Recently, Beyond laparoscopy-assisted distal gastrectomy (LADG), which has the mini-laparotomy, TLDG, which has no mini-laparotomy in epigastrium but in umbilicus, has been popular procedure in the treatment of gastric cancer. Furthermore, the report on early experience of SIDG, which has no incision except umbilicus port, is going to be published.
However, there've been no objective reports and data on real minimal invasiveness and benefits between 2 procedures. In this study, I would like to find out the benefits of the reducing port and wound size by comparing the above 2 procedures' immune response and postoperative complications.
This study is planned as a phase II study.
There are no references on this subject, so the investigators set the numbers of each groups into 30, which is minimal requirement for the parametric comparisons.
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
- •clinically early gastric cancer, potentially possible to perform distal gastrectomy (cancer in the distal 2/3rds)
- •20< Age < 80
排除标准
- •history of other malignancy
- •received preoperative chemotherapy
研究组 & 干预措施
Multi-port laparoscopic distal gastrectomy
Laparoscopic distal gastrectomy using the conventional 5-port access
干预措施: Approach Method (Procedure)
Single incision distal gastrectomy
Pure single incision distal gastrectomy using one transumbilical incision
干预措施: Approach Method (Procedure)
结局指标
主要结局
Maximum pain score using VAS at postoperative day#1
时间窗: Postoperative day 1
Maximum postoperative pain using the visual analogue scale
次要结局
- Estimated blood loss(During operation)
- Time to first soft fluid diet(Days until first soft fluid diet)
- Operation time(Time during operation)
- Hospital stay(Days until discharge)
- Maximum pain scores using VAS(From postoperative day 0 to 5)
- Early postoperative complication(within 30 days from the operation)
- Time to first flatus(Days until first flatus)
- EORTC-C30 and STO22(Preoperative, 2 weeks after surgery, 1 month after surgery, 6 months after surgery, 12 months after surgery)
研究者
Sang-Hoon Ahn
Professor
Seoul National University Bundang Hospital