Laparoscopic vs robotic lateral pelvic lymph node dissection in locally advanced rectal cancer: a cohort study comparing peri-operative morbidity and short-term oncological outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- i.Postoperative morbidity
研究概览
简要总结
Robotic surgery has been associated with superior short-term outcomes in patients undergoing total mesorectal excision (TME) for organ-confined rectal cancer. However, whether this approach offers an additional benefit over laparoscopy when performing lateral pelvic lymph node dissection (LPLND) with TME or extended TME in locally-advanced rectal cancer (LARC) with clinically-significant lateral pelvic lymphadenopathy is not known.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •consecutive patients with non-metastatic, histopathologically-proven rectal adenocarcinoma with significant lateral pelvic lymphadenopathy, undergoing elective curative-intent minimally-invasive (laparoscopic or robotic) TME or extended-TME and LPLND, regardless of the receipt of neoadjuvant therapy during the study period.
排除标准
- •Patients with a history of having undergone pelvic surgery in the past, histologies other than adenocarcinoma, or presenting with locally-advanced tumors requiring adjacent organ resections or pelvic exenterations.
- •Pateint with incomplete medical records.
结局指标
主要结局
i.Postoperative morbidity
时间窗: 2 years
ii.Positive margins (including CRM)
时间窗: 2 years
iii.Median LPLN yield (IQR)
时间窗: 2 years
iv.LPLN positivity rate
时间窗: 2 years
v.Lateral Pelvic Recurrence rate
时间窗: 2 years
vi.2-year Event-free Survival
时间窗: 2 years
vii.2-year Overall Survival
时间窗: 2 years
次要结局
- i.Distribution of complications in the postoperative period.(ii.Length of hospital stay)
研究者
Dr Avanish Saklani
Tata Memorial Hospital Dr. Ernest Borges Street, Parel, Mumbai (India)