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临床试验/NCT05267275
NCT05267275招募中不适用

Effect of Splenic Flexure Mobilization With Extended Resection of the Proximal Colon for Rectal Cancer With Neoadjuvant Radiotherapy on Postoperative Complications

Qilu Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
incidence of complications related to rectal anastomosis

研究概览

简要总结

Preoperative neoadjuvant therapy has become the guideline-recommended standard treatment for patients with locally advanced or mid-to-low rectal cancer with suspected regional lymph node metastasis. However, preoperative neoadjuvant radiotherapy caused radiation damage to the pelvic bowel, resulting in varying degrees of edema, vascular stiffness, and insufficient blood supply. According to the traditional rectal cancer surgery, the proximal bowel resection only needs to be more than 10cm above the upper edge of the tumor. However, this range of resection cannot remove all the damaged proximal bowel, and using the damaged proximal bowel for anastomosis may lead to the risk of anastomotic-related complications (including anastomotic leakage, anastomotic stenosis, and anastomotic proximal bowel stiffness, etc.) also increased. Therefore, extended resection of the proximal bowel with splenic flexure mobilization and using healthy proximal bowel for anastomosis may help reduce the incidence of complications related to rectal anastomosis after neoadjuvant therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

入选标准

  • Patients with mid-low rectal cancer who received preoperative neoadjuvant therapy (tumor distance ≤12cm from the anus);
  • The preoperative local stage is cT3-4N0-2M0 or cT3-4N0-2M1 (M1 is limited to liver metastases that can be surgically removed at the same time)
  • Preoperative neoadjuvant therapy (long-course concurrent chemoradiation or TNT)
  • Aged between 18-75 years old;
  • ASA rating: 0-2
  • ECOG Score: 0-2
  • BMI 18-30 kg/m2;
  • Radical surgical resection is expected to be possible on the basis of preserving the anus;
  • Sign the informed consent document.

排除标准

  • History of other malignant tumors;
  • Emergency surgery patients;
  • Severe underlying diseases, unable to tolerate surgery;
  • Without informed consent.

结局指标

主要结局

incidence of complications related to rectal anastomosis

时间窗: From the end of the surgery to 1 year after ileostomy closure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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