Lymph Node Dissection
ProcedureThe extent of lymph node dissection varies between groups
Other names: Fluorescence-guided laparoscopic surgery, Radical operation for rectal cancer and sigmoid Cancer
NCT Number: NCT05730595
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The extent of lymph node dissection varies between groups
Other names: Fluorescence-guided laparoscopic surgery, Radical operation for rectal cancer and sigmoid Cancer
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.
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 overall survival assessment is the last follow-up or patient death. Follow-up time is up to 36 months.
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: Until the pathological result is available , an average of 14 days.
The number of lymph nodes removed during surgery, which is obtained by postoperative pathological results
Time frame: Until the end of the operation, an average of 8 hours.
Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).
Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.
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 is defined as the length of time from the end of surgery
Time frame: Until one year after the patient's surgery
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.
Contact information is provided by the study sponsor or research team.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Other
A Randomized Controlled Trial of Fluorescence Laparoscopic Navigation of the Extent of Lymph Node Dissection for High Rectal Cancer and Sigmoid Colon Cancer
Acronym: FLORA-01
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