rectal cancer
Conditions
Interventions
Group NOSE:operation+natural orifice specimen extraction
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. According to NCCN rectal cancer diagnosis and treatment guidelines, no anti-tumor treatment (cT1-2N0M0) or standard neoadjuvant chemoradiotherapy (cT3-4N0M0 or any T, N1-2) was applied before the clinical trial; 2. Aged between 18 and 80 years old; 3. Colonoscopy was performed and rectal carcinoma was pathologically diagnosed; 4. Tumor position: 2cm-18cm from the dentate line; 5. Preoperative MRI evaluation: T1-3, N0 - N1, feasible for standard laparoscopic TME Dixon operation (AJCC 2010 7th edition); 6. Good bone marrow function, blood routine meet the following conditions: white blood cell count = 3.5 x 10^9/L, neutrophils = 1.5 x 10^9/L, platelet count = 100 x 10^9/L , hemoglobin = 70 g/L; 7. Good viscera function and biochemical tests meet the following conditions: ALT =2.5 times of upper limit of normal(ULN), AST = 2.5 times of ULN, serum total bilirubin =1.5 times of ULN, serum creatinine =1.5 times of ULN. 8. ECOG score 0-2; 9. Radiographic evaluation of tumor diameter is not greater than 5cm; 10. BMI = 28 kg/m2; 11. Consent to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. 5 years history of other malignant tumors; 2. Multiple colorectal cancer or other malignant tumors; 3. Distant metastases (M1); 4. Preoperative imaging evaluation: lateral pelvic lymph nodes, para-aortic lymph node metastasis; 5. Preoperative rectal cancer with intestinal obstruction or a history of colorectal surgery; 6. Tumor invasion of dentate line or anal levator; 7. Serious medical disorders (including hepatic dysfunction, renal failure, severe diabetes, lung function failure, etc.); 8. Long-term use of hormone or immunosuppressants; 9. Serious or uncontrol mental illness; 10. Abuse of drugs and medical, psychological or social conditions may interfere the results of assessment; 11. Any unstable situation or may endanger the patient's safety and compliance; 12. Receiving anticancer drug therapy in other clinical trail.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year DFS;3-year OS;3-year DFS;Recurrence rate;operating time;CHIPPS;Postoperative exhaust time;postoperative morbidity;QOL;incisional hernia; | — |
Countries
China
Contacts
Public ContactHan Fanghai
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed