Rectal Cancer
Conditions
Brief summary
This study aims to compare the effectiveness of robotic surgery versus laparoscopic surgery in treating low rectal cancer. While robotic surgery has gained popularity, there is limited long-term evidence regarding its outcomes. By using real-world data from a specialized multicenter colorectal cancer database in Shanghai, China, this retrospective cohort study will emulate the target trial to evaluate whether robotic surgery offers advantages over laparoscopic surgery. Key factors such as disease-free survival, locoregional recurrence, circumferential margin positivity, and postoperative complications will be examined. The goal is to provide stronger, evidence-based support for the clinical use of robotic surgery in treating low rectal cancer.
Interventions
PROCEDURERobotic surgery
Robotic surgery for radical resection of middle and low rectal cancer
PROCEDURELaparoscopic surgery
Laparoscopic surgery for radical resection of middle and low rectal cancer
Sponsors
Xu jianmin
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age from 18 years to 80 years; 2. American Society of Anesthesiologists (ASA) class I - III; 3. Histologically proved rectal adenocarcinoma; 4. Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy; 5. Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI; 6. No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, etc; 7. No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri; 8. Received either robotic or laparoscopic surgery; 9） Surgery with radical intent; 10\) Informed consent.
Exclusion criteria
1. Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc; 2. Synchronous colon surgery for multiple colorectal tumors or other schedules; 3. Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.); 4. Co-existent inflammatory bowel disease; 5. Pregnancy or lactation; 6. Patients received treatment other than preoperative radio- or chemoradiotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year postoperative disease-free survival rate | From surgery to three years postoperatively | Disease-free survival event is defined as any death or locoregional recurrence or distant metastases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circumferential resection margin positivity rate | 14 days during postoperative pathological examination | Circumferential resection margin positivity is defined as 1 mm or less from the tumor. |
| 30-day postoperative complication rate (Clavien-Dindo grade 2 or higher grade) | From surgery to 30 days postoperatively | 30-day postoperative complication rate is defined according to the Clavien-Dindo grade system. Only complications in grade 2 or higher grade will be calculated. |
| rate of abdominoperineal resection | 30 days after surgery | percentage of patients received abdominoperineal resection |
| 3-year postoperative locoregional recurrence rate | From surgery to three years postoperatively | Locoregional recurrence is defined as any cancer recurrence in the pelvic or perineal area. |
Countries
China
Outcome results
None listed