Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Rectal Cancer: a Multicentre Propensity Score-Matched Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 636
- 试验地点
- 8
- 主要终点
- Complication rate
研究概览
简要总结
A retrospective cohort study, conducted nationwide（China） and across multiple centers, aimed to compare the surgical quality and short-term outcomes of R-NOSES （robotic natural orifice specimen extraction surgery）with R-TSES （robotic transabdominal specimen extraction surgery） for early-stage rectal cancer.
详细描述
In this retrospective cohort study, data from 1086 patients who underwent R-NOSES or R-TSES for early-stage rectal cancer between October 2015 and November 2023 were collected from a prospectively maintained database of 8 experienced surgeons from 8 high-volume centers in china. The study was aimed to compare the surgical quality and short-term outcomes of R-NOSES with R-TSES for early-stage rectal cancer.
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
- 20 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed rectal adenocarcinoma
- •robotic TME for rectal adenocarcinoma
- •postoperative pathological staging of T1-2N0M0
- •complete surgical and postoperative follow-up information
排除标准
- •body mass index (BMI) ≥ 35 kg/m2
- •history of abdominal surgery
- •history of pelvic surgery
- •presence of another primary cancer
- •previous endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)
- •anal or vaginal disease
- •ileostomy or transverse colostomy
- •conversion to open operation
- •tumor distant metastasis
结局指标
主要结局
Complication rate
时间窗: Up to 30 days postoperatively
Complication rate within 1 month postoperatively.All complications of surgery will be documented and graded by the Clavien-Dindo classification system,generally including anastomotic leakage, abdominal infection, bleeding, incision infection, incision implantation, intestinal obstruction, and rectovaginal fistula.
次要结局
- EORTC QLQ-C30(Three months after surgery)
- Estimated blood loss(Intraoperative)
- Pain assessment(1, 3, 5 days postoperatively)
- Operative time(Intraoperative)
- Postoperative hospital stay(Up to 4 weeks)
- C-reactive protein (CRP)(1, 3, 5 days postoperatively)
- Postoperative recovery composite(Up to 2 weeks)
- Postoperative white blood(1, 3, 5 days postoperatively)
- BIQ(Three months after surgery)
研究者
Taiyuan Li
Professor
The First Affiliated Hospital of Nanchang University