NCT07736131已完成不适用
The Influence of the Learning Curve on the Short-term and Long-term Efficacy of Single-incision Laparoscopic Rectal and Sigmoid Colon Surgery: An Observational Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 主要终点
- Number of cases for the learning curve
研究概览
简要总结
Based on the data analysis of the General Surgery Department (Northern Department) of Ruijin Hospital from December 2013 to June 2021, we conducted a retrospective cohort study. Multivariate risk-adjusted cumulative sum analysis (RA-CUSUM) was used to evaluate the learning curve of single-incision laparoscopic surgery performed by the same surgical team based on short-term surgical outcomes. Subsequently, by comparing the 5-year follow-up results of patients who received treatment at different stages of the learning curve, analyses of overall survival and progression-free survival were conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Patients with indications for single-port laparoscopic surgery; 2) A single tumor was found during colonoscopy; 3) Preoperative biopsy confirmed by pathology as cancer or high-grade intraepithelial neoplasia; 4) The lesion is located in the lower segment of the sigmoid colon (20 cm to 25 cm from the proximal rectum), the junction of the sigmoid colon (16 cm to 20 cm from the proximal rectum), or the upper segment of the rectum (12 cm to 16 cm from the proximal rectum) [31-33]; 5) Intestinal anastomosis in vivo was performed through a tubular stapler.
排除标准
- •1) Has undergone colorectal resection; 2) Preoperative CT assessment shows that the tumor stage is stage IV (as defined in the 8th edition of the American Joint Committee on Cancer (AJCC) "Cancer Staging Manual"); 3) Intestinal anastomosis was performed in vitro or not; 4) Received neoadjuvant therapy; 5) ASA classification is III-IV (in accordance with the ASA standards of the American Society of Anesthesiologists); 6) Life expectancy is less than one year; 7) There is a history of cancers other than thyroid cancer.
结局指标
主要结局
Number of cases for the learning curve
时间窗: week 4
次要结局
未报告次要终点
研究者
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