Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 主要终点
- Overall survival
研究概览
简要总结
Robotic rectal cancer resection with natural orifice extraction is a recently developed minimally invasive surgery for patients with rectal cancer. However, it's safety and feasibility remain undiscussed and controversial. This study reported the clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice extraction to discuss aforementioned question.
详细描述
Robotic rectal cancer resection with natural orifice extraction is a recently developed minimally invasive surgery for patients with rectal cancer. However, it's safety and feasibility remain undiscussed and controversial. This study reported the clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice extraction to discuss aforementioned question. From January 2015 to November 2016, a consecutive wave of 49 patients underwent robotic rectal cancer resection with natural orifice extraction and 49 matched patients underwent conventional robotic assisted rectal cancer resection were systematically analyzed in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T stage 1-3;
- •aged between 18 to 75;
- •the tumor margin is at least 4 cm from the anus;
- •body mass index ≤30kg/m2;
- •no distant metastases； (6）tumor size≤5cm.
排除标准
- •emergency surgery for intestinal obstruction or massive bleeding;
- •history of abdominal or pelvic surgery.
结局指标
主要结局
Overall survival
时间窗: Up to 36 months
To determine the survival differences between NOSE group and RARC group. Overall survival is defined as the time from surgery to death from any causes
Disease-free survival
时间窗: Up to 36 months
To determine the survival differences between NOSE group and RARC group. Disease-free survival is defined as the time from surgery to local or distant recurrence
次要结局
- Operation time(1 day)
- Estimated intraoperative blood loss(1 day)
- Postoperative hospital stay(30 days)
- Postoperative visual analogue scale scale on day 1(1 day)
- Time to pass flatus(30 days)
- Hospitalization costs(30 day)
- Specimen length(30 day)
- Proximal margin(30 day)
- Distal margin(30 days)
- Postoperative white blood cell count(30 days)
- Postoperative procalcitonin(30 days)
- Histological differentiation(30 days)
- Number of lymph nodes harvested(30 days)
- Postoperative C-reactive protein(30 days)
研究者
Taiyuan Li
Prof., Chief physician, Head of The Fifth Department of General Surgery
The First Affiliated Hospital of Nanchang University