Rectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female; 2. subjects 18 - 70 of age; BMI less than 3030kg/m2; 3. biopsy-proven adenocarcinoma of the rectum; 4. no previous abdominal surgery, no distant metastasis or synchronous colon cancer; 5. clinical staging (T1 or T2 or T3) with N1-2M0; 6. distance from tumor to anal verge should greater than 3cm; 7. the diameter of primary tumor should smaller than 5cm; 8. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 9. American Society of Anesthesiology (ASA) class I to III lesions; 10. after the evaluation of Multi-disciplinary team (MDT), whether receive neoadjuvant chemoradiotherapy or not; 11. written informed consent.
Exclusion criteria
Exclusion criteria: 1. obstructing, perforated or hemorrhagic rectal cancer require for emergent surgery; 2. T4 tumor that invade the external sphincter or levator ani muscle or neighbor organs that should undergo multivisceral resection; 3. pregnant or breast-feeding women; 4. fecal incontinence; 5. mental disorder or disease; 6. history of inflammatory bowel disease; 7. other malignancies diagnosed within the previous year; 8. severe impaired renal and hepatic function, coagulopathy or other severe comorbidities that cannot tolerate surgery; 9. any evidence of active infection; 10. cannot reach written informed consent.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| recovery outcome;postoperative pain evaluation;defecation, urinary and sexual function;Quality of life;3 year disease free survival;3 year overall surviva; | — |
Primary
| Measure | Time frame |
|---|---|
| Operative time;Estimated blood loss;intraoperative complications;conver to Hybrid NOTES with assistance of conventional laparoscopic surgery;conver to open surgery;postoperative complication;pathological outcome;cost of hospitalization; | — |
Countries
China