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

NCT06814093 | Active Not Recruiting

• 1 other identifier: CCS-DASET-TTE-REAL
• Study Type: observational
• Target: 2,702
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 3-year postoperative disease-free survival rate

  Disease-free survival event is defined as any death or locoregional recurrence or distant metastases.

  From surgery to three years postoperatively

Secondary Outcomes (4)

• 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

Study Arms (2)

Robotic group

Patients received robotic surgery for middle and low rectal cancer

Procedure: Robotic surgery

Laparoscopic group

Patients received laparoscopic surgery for middle and low rectal cancer

Procedure: Laparoscopic surgery

Interventions

Robotic surgery PROCEDURE

Robotic surgery for radical resection of middle and low rectal cancer

Robotic group

Laparoscopic surgery PROCEDURE

Laparoscopic surgery for radical resection of middle and low rectal cancer

Laparoscopic group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The data is sourced from the Colorectal Cancer Specialty Cohort Database and Biobank, established through the "Construction and Application of the Shanghai Colorectal Cancer Specialty Cohort Database and Biobank" project. The research will utilize cohort data collected from January 2021 to May 2022 (17 months). This specialized database was led by Zhongshan Hospital, Fudan University, in collaboration with Shanghai Tenth People's Hospital, Fudan University Shanghai Cancer Center, First Affiliated Hospital of Naval Medical University (Changhai Hospital), Renji Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Shanghai First People's Hospital.

You may qualify if:

• 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;
• \) Informed consent.

You may not qualify if:

• Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;
• Synchronous colon surgery for multiple colorectal tumors or other schedules;
• Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
• Co-existent inflammatory bowel disease;
• Pregnancy or lactation;
• Patients received treatment other than preoperative radio- or chemoradiotherapy.

Sponsors & Collaborators

• Xu jianmin: lead

Study Sites (1)

Zhongshan Hospital, Fudan University, Shanghai, China

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Robotic Surgical Procedures; Laparoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Colorectal Surgery

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: January 1, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)