Rectal adenocarcinoma
Conditions
Interventions
Intervention group:The surgery was completed using the CarinaTM modular surgical robot system and the corresponding surgical instruments.
Control group:The surgery was performed using the Da VinciTM integrated surgical robot system and the corresponding surgical instruments.
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 to 80 years old, gender not restricted; 2. Rectal adenocarcinoma confirmed by histopathological examination; 3. The lower edge of the rectal tumor is no more than 10 cm away from the anal margin; 4. The clinical stage of the tumor meets the following criteria: (1) cT1-cT3 (not invading the rectal mesenteric fascia); (2) N0-N1, or N2 that can be surgically removed after assessment; (3) M0 (no distant metastasis). 5. The patients were evaluated by the researchers to be suitable for radical resection of rectal cancer using surgical robots (including preoperative neoadjuvant radiotherapy and chemotherapy); 6. Before the operation, the researchers evaluated that the postoperative patients had sufficient organ functions; 7. Agree to participate in this study and voluntarily sign the informed consent form; 8. Willing to cooperate in completing the follow-up and related examinations, with good compliance; 9. ASA classification: grades I–III.
Exclusion criteria
Exclusion criteria: 1. Patients with severe diseases of the heart, lungs, brain, liver or kidneys who cannot tolerate surgery or anesthesia; 2. Patients who cannot tolerate pneumoperitoneum or who, based on the investigator's judgment, have a high risk of extensive and severe adhesions in the abdominal cavity and are therefore unable to undergo puncture and establishment of pneumoperitoneum; 3. Patients with severe coagulation dysfunction who cannot tolerate surgery; 4. Patients with active pulmonary tuberculosis; 5. Individuals with severe uncontrolled diseases or acute infections; those with severe physical weakness, large amounts of peritoneal effusion, internal bleeding or shock; 6. Patients with distant metastasis of the tumor (cM1) or extensive invasion of adjacent organs (cT4b); 7. Patients who require emergency surgery due to acute intestinal obstruction, massive hemorrhage; 8. In addition to rectal tumors, there are also multiple primary colon tumors that require surgical treatment; 9. Patients with other specific intestinal diseases, such as inflammatory bowel disease and familial adenomatous polyposis, who have been assessed as unsuitable for surgery; 10. Patients with a history of abdominal or pelvic surgeries or radiotherapy and chemotherapy who are not suitable for surgery; 11. Pregnant and lactating women; 12. Patients who are currently participating in other clinical trials of drugs or devices; 13. The researchers identified patients who were not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative complication rate (Clavien-Dindo classification); | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor resection quality indicators (including the integrity of the TME after mesorectal resection, the positive rate of CRM at the circumferential resection margin, the maximum diameter of the tumor, etc.);Safety and efficacy indicators 30 days after surgery (including the incidence of various postoperative complications, anastomotic leakage rate after surgery, reoperation rate within 30 days after surgery, etc.);Intraoperative surgical quality indicators (including surgical conversion rate, mechanical arm Docking time, total operation time, etc.); | — |
Countries
China
Contacts
Public ContactZhu Yuping
Zhejiang Cancer Hospital
Outcome results
None listed