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

NCT ID: NCT06814093

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2702 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-04-30

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.

Conditions

Rectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Robotic group

Patients received robotic surgery for middle and low rectal cancer

Robotic surgery

Intervention Type: PROCEDURE

Robotic surgery for radical resection of middle and low rectal cancer

Laparoscopic group

Patients received laparoscopic surgery for middle and low rectal cancer

Laparoscopic surgery

Intervention Type: PROCEDURE

Laparoscopic surgery for radical resection of middle and low rectal cancer

Interventions

Robotic surgery

Robotic surgery for radical resection of middle and low rectal cancer

Intervention Type: PROCEDURE

Laparoscopic surgery

Laparoscopic surgery for radical resection of middle and low rectal cancer

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xu jianmin

OTHER

Sponsor Role: lead

Responsible Party

Xu jianmin

Director of Colorectal Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhongshan Hospital, Fudan University, Shanghai, China

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CCS-DASET-TTE-REAL

Identifier Type: -

Identifier Source: org_study_id