To explore the short-term and long-term outcomes of fluorescence laparoscopic navigation D2 lymph node dissection for colorectal cancer surgery by comparing it with D3 lymph node dissection.
Lymph node metastasis is the most common metastatic mechanisms for colorectal cancer. Therefore, regional lymph node dissection is the key part in radical surgery for colorectal cancer. In patients who have developed lymph node metastases, inadequate lymph node dissection will promote tumor recurrence. In patients who do not develop lymph node metastases, excessive lymph node dissection not only does not improve the patient's prognosis, but also increases surgical trauma and destroys the antitumor effect of the lymphoid immune system. There is still some controversy over whether to choose D3 lymph node dissection or D2 lymph node dissection for rectal and sigmoid cancer. Fluorescence laparoscopic navigation techniques can guide lymph node dissection by visualizing lymph nodes more clearly during surgery. This study will compare the short-term and long-term oncological outcomes between fluorescence laparoscopic navigation D2 and D3 lymph node dissection by conducting a randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
550
The extent of lymph node dissection varies between groups
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Disease-free survival
Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months.
Time frame: The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 36 months.
Overall survival
Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.
Time frame: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 36 months.
The number of lymph node resection
The number of lymph nodes removed during surgery, which is obtained by postoperative pathological results
Time frame: Until the pathological result is available , an average of 14 days.
Blood loss
Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).
Time frame: Until the end of the operation, an average of 8 hours.
Complications
Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.
Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.
Hospital stay after surgery
Hospital stay after surgery is defined as the length of time from the end of surgery
Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Chengdu, China
Fujian Province Tumor Hospital
Fuzhou, Fujian, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
...and 9 more locations
Function score
Function score includes International Prostate Symptom Score, low anterior resection syndrome score and International Index of Erectile Function-5 score, which are used for assess the physical function.
Time frame: Until one year after the patient's surgery