Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation (NCT06814093) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation
China2,702 participantsStarted 2021-01-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age from 18 years to 80 years;
✓. American Society of Anesthesiologists (ASA) class I - III;
✓. Histologically proved rectal adenocarcinoma;
✓. Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy;
✓. Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI;
✓. No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, etc;
✓. No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
✓. Received either robotic or laparoscopic surgery; 9） Surgery with radical intent;
Exclusion criteria
✕. Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;
What they're measuring
1
3-year postoperative disease-free survival rate
Timeframe: From surgery to three years postoperatively