Comparision of the Outcomes and Learning Curve of Rectectomy for Rectal Cancer Using Diverse Minimally Technologies: Surgical Robot "Micro Hand S", Laparoscope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Quality of specimen
研究概览
简要总结
Central South University in collaboration with Tianjin University developed the first domestically produced Chinese minimally invasive surgical (MIS) robot system which named "Micro Hand S" in 2013. This new MIS robot had been authorized to enter the clinical trial stage by the Ethics Committee of the Third Xiangya Hospital at Central South University. The Micro Hand S robot is safe and feasible in the preliminary study. However, compared with minimally invasive approaches (da Vici, laparoscope), the merits and demrits of rectectomy for rectal cancer are unclear. Therefore, the investigators conduct this retrospective study to focus on this concern.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •histologically confirmed rectal cancer; ASA score < 3
排除标准
- •palliative resections, combined resections, distant metastasis, a previous history of abdominal/or pelvic surgery
结局指标
主要结局
Quality of specimen
时间窗: up to 1 month after operation
The quality of the speciman was graded according to the protocol proposed by Quirke
Type of surgical procedure
时间窗: up to 1 week after operation
It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection
Operative time (min)
时间窗: up to 1 week after operation
It was defined as the duration from skin incision to skin closure
Protective ileostomy
时间窗: up to 1 month after operation
It was defined as ileostomy which diverted the feces to To ensure anastomotic healing
pTNM stage
时间窗: up to 1 month after operation
It was defined as the pathological stage of the tumor according the TNM classification
Disease free survival
时间窗: at least 1 years after operation
It was defined as the duration between the operation and date of the tumor recurrence
Conversion
时间窗: up to 1 week after operation
Conversion was defined as any change in strategy to open surgery
Bloos loss (ml)
时间窗: up to 1 week after operation
It was defined as the amount of blood in the whole surgical time
Hospital stay (day)
时间窗: up to 1 month after operation
It was defined as the length of hospital stay
Tumor size (cm)
时间窗: up to 1 month after operation
It was defined as the longitudinal diameter of the tumor
Retrieved lymph node
时间窗: up to 1 month after operation
It was defined as the number of all the lymph nodes for each patien
Status of the surgical margin
时间窗: up to 1 month after operation
It was defined as whether the distal and circumferential resection margins was involved the tumor cell under microscope
Postoperative complication
时间窗: up to 1 month after operation
It was defined as the adverse events after operation and the complications were classfied according to the Clavien-Dindo (C-D) classification
Local recurrence
时间窗: at least 1 years after operation
It was defined as the tumor was again found in the pelvic cavity
Length of distal ressction margin (cm)
时间窗: up to 1 month after operation
It was defined as the distance betwen the distal resection margin and the low margin of the tumor
International Prostate Symptom Score
时间窗: at least12 months after operation
It assessed the urination with 7 items
International Index of Erectile Function
时间窗: at least 12 months after operation
It assessed erectile function with 5 items
次要结局
未报告次要终点