Total Mesorectal Resection With Dissection of the Lateral Pelvic Lymph Nodes in Low Advanced Cancer Rectum Patients; Laparoscopic Versus Open Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- feasibility of procedure
研究概览
简要总结
To compare the open approach and the laparoscopic-assisted approach of dissection of lateral lymph nodes in low advanced rectal cancer patients with clinically suspected nodal metastases in terms of safety, technical feasibility, and patient's oncological outcomes.
详细描述
the investigators collected data of sixty low advanced cancer rectum patients who underwent either laparoscopic (30 cases) or open total mesorectal excision (30 cases) in addition to lateral pelvic dissection. The duration of operation in the laparoscopically assisted procedure was longer than the open procedure (p=0.003). The postoperative hospital stay time was longer in the open group than in the laparoscopic group (P=0.043). No significant differences between both groups regarding the number of excised lymph nodes, disease recurrence, RFS, or OS rate.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 20-70 years with
- •Sure diagnosis of locally advanced (T3 and T4) adenocarcinoma located in the middle or lower part of the rectum
- •Clinical or radiological evidence of lateral pelvic lymph nodes metastases
排除标准
- •Patients refused to be included in the study,
- •Patients with concurrent primary cancer in other locations
- •Patients with recurrent cancer after treatment
- •Patients with distant metastasis
- •Previously managed for pelvic cancer
研究组 & 干预措施
group 2
open excision of mesorectum
干预措施: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision (Procedure)
group 1
underwent laparoscopic-assisted excision of mesorectum
干预措施: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision (Procedure)
结局指标
主要结局
feasibility of procedure
时间窗: operative time
easy or difficult
operative complication
时间窗: durning operative time
bleed-injury of organs -failed procedure
operative time
时间窗: during operative time
time of surgery in minutes
次要结局
- recurrence(5 years)
- mortality(5 years)
- post operative morbidity(5 years)
研究者
osama khalil
assistant professor
Zagazig University