Phase 2 Study of Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Harvested numbers of lymph node
研究概览
简要总结
Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single incision (Embryonic NOTES) colon surgery has been attempted.
However, there are not sufficient evidences for single incision colon surgery in colon cancer.
The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer.
详细描述
After several randomized clinical trials, laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single Incision (Embryonic NOTES) colon surgery has been attempted. Several studies reported the feasibility of single incision colon surgery.However, there are not sufficient evidences for single incision colon surgery, especially in colon cancer.
The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer. Harvested numbers of lymph node will be assessed for the efficacy and postoperative morbidity and mortality will be assess for the safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients should sign a written informed consent
- •Age between 18-80
- •Patients have sigmoid colon cancer that was proved by pathology
- •Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
- •Adequate kidney function Creatinine ≤ 1.5 mg/dl
- •No remarkable evidence of heart dysfunction and lung dysfunction
排除标准
- •Distant metastasis
- •Tumor diameter > 5 cm
- •Other organ invasion
- •Intestinal obstruction and stent insertion status
- •Patient was used steroid
- •Patients undergo emergency surgery with multiple symptoms
- •Other organ cancer history (except who had radical excision for skin cancer)
- •Presence of other serious disease
- •Mentally ill patients
- •Legally unable to participate in clinical trial
- •Lactating or pregnant women
- •Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
- •Not eligible to participate for other reasons by doctor's decision
研究组 & 干预措施
Single incision sigmoidectomy
Single incision laparoscopic sigmoidectomy for sigmoid colon cancer
干预措施: Single Incision Laparoscopic Surgery (Procedure)
结局指标
主要结局
Harvested numbers of lymph node
时间窗: Within the first 7 days (plus or minus 3 days) after surgery
次要结局
- Postoperative mortality, morbidity(Within 30 days after operation)
研究者
Ji Won Park
Principal Investigator
National Cancer Center, Korea