The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid and low rectal cancer surgery. Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No.253 lymph node.
The No.253 lymph node, as the third station in the inferior mesenteric artery lymphatic system, plays a significant role in the lymphatic circulation of the descending colon, sigmoid colon, and rectum. They act as the last barrier for tumor metastasis from the regional to distant areas. However, there is still controversy regarding whether rectal cancer patients universally require dissection of the No.253 lymph node. The rate of metastasis to the No.253 lymph node in rectal cancer patients is extremely low, and dissection may not bring survival benefits. Additionally, postoperative urinary and sexual functions may be impaired due to damage to the sympathetic nerves. However, current prospective randomized controlled trials on the safety of omitting the dissection of the No.253 lymph node have small sample sizes and lack sufficient test power. Further confirmation is needed from large-sample prospective randomized controlled studies. Based on this, the investigator plans to collaborate with Peking Union Medical College Hospital, China-Japan Friendship Hospital, Chinese People's Liberation Army General Hospital, Shanghai Ruijin Hospital, Fudan Cancer Hospital, and West China Hospital of Sichuan University, totaling eight medical centers, to conduct a prospective randomized controlled study. This study aims to confirm the safety of mid and low rectal surgery without dissection of the No.253 lymph node, providing high-level evidence-based medical evidence for the implementation of this surgical technique.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,384
The range of the No.253 lymph node is as follows: medially, it extends from the root of the inferior mesenteric artery to the starting section of the left colonic artery; caudally, from the starting point of the left colonic artery to the intersection with the inferior mesenteric vein; laterally, it is bordered by the outer margin of the inferior mesenteric vein; and cranially, from the horizontal section of the duodenum to the beginning of the jejunum. In the controlled group, the surgery is performed with dissection of the No.253 lymph node.
In the experimental group, the surgery is performed without dissection of the No.253 lymph node.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChinese PLA General Hospital
Beijing, Beijng, China
NOT_YET_RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Chaoyang District, China
RECRUITINGRuijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Hospital Sichuan University
Chengdu, Sichuan, China
NOT_YET_RECRUITING3-year disease free survival rate
Disease free survival refers to the length of time after primary treatment during which a patient survives without any signs or symptoms of the cancer.
Time frame: 3 years after surgery
Number of harvested lymph nodes
Total number of lymph nodes dissected in the pathology report
Time frame: About 10 days after surgery
Incidence of postoperative complications
The proportion of short-term complications occurring within 30 days post-surgery
Time frame: 30 days after surgery
Intraoperative blood loss
Total blood loss during the surgery
Time frame: Intraoperative
Operative duration
total time spent performing a surgical procedure. This time is typically measured from the moment the surgery begins (marked by the initial incision) to its conclusion (marked by the closure of the surgical wound)
Time frame: Intraoperative
Postoperative urination and sexual function
Three months, six months, and one year postoperatively, evaluate patients' urinary and sexual functions using scales.
Time frame: 1 year after surgery
3-year local recurrence rate
Local recurrence refers to the return of cancer in the same area where it originally developed, typically after treatment has been completed.
Time frame: 3 years after surgery
3-year overall survival rate
Overall survival refers to the length of time from the primary treatment that patients are still alive.
Time frame: 3 years after surgery
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