Robotic surgery: Robotic surgery for radical resection of middle and low rectal cancer
Laparoscopic surgery: Laparoscopic surgery for radical resection of middle and low rectal cancer
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Zhongshan Hospital, Fudan University, Shanghai, China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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