Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation

Xu jianmin

Status: Active, not recruiting

Conditions: Rectal Cancer

Treatments: Procedure: Laparoscopic surgery; Procedure: Robotic surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06814093

CCS-DASET-TTE-REAL

Details and patient eligibility

About

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.

Enrollment: 2,702 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

2,702 participants in 2 patient groups

Robotic group

Description:

Patients received robotic surgery for middle and low rectal cancer

Treatment:

Procedure: Robotic surgery

Laparoscopic group

Description:

Patients received laparoscopic surgery for middle and low rectal cancer

Treatment:

Procedure: Laparoscopic surgery