Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: A Retrospective Cohort Study Emulating the Target Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2,702
- Locations
- 1
- Primary Endpoint
- 3-year postoperative disease-free survival rate
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
3-year postoperative disease-free survival rate
Time Frame: From surgery to three years postoperatively
Disease-free survival event is defined as any death or locoregional recurrence or distant metastases.
Secondary Outcomes
- Circumferential resection margin positivity rate(14 days during postoperative pathological examination)
- 30-day postoperative complication rate (Clavien-Dindo grade 2 or higher grade)(From surgery to 30 days postoperatively)
- rate of abdominoperineal resection(30 days after surgery)
- 3-year postoperative locoregional recurrence rate(From surgery to three years postoperatively)
Investigators
Xu jianmin
Director of Colorectal Surgery
Fudan University