A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry

Samsung Medical Center

Status: Enrolling

Conditions: Rectosigmoid Cancer; Rectosigmoid Junction Cancer; Rectal Cancer

Treatments: Device: ArtiSential

Study type: Observational

Funder types: Other

Identifiers

NCT05566249

SMC-2022-01-174

Details and patient eligibility

About

This study is to validate the safety and feasibility of ArtiSential (Articulating laparoscopic instrument) colorectal surgery and compare it with robotic surgery for patients with rectal cancer and rectosigmoid junction cancer.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age : 18 ~ 80 year old male or female
• Biopsy-proven adenocarcinoma
• Rectal cancer or Rectosigmoid junction cancer
• Primary cancer
• Non-metastatic cancer
• Planned (or elective) curative resection
• Low anterior resection with double-stapled technique

Exclusion criteria

• Preoperative systemic chemotherapy
• Distant metastasis at initial diagnosis
• Palliative surgery
• Emergent surgery
• Lynch syndrome or FAP-associated cancer

Trial design

1,000 participants in 2 patient groups

ArtiSential group

Description:

Patients undergoing laparoscopic surgery using ArtiSential

Treatment:

Device: ArtiSential

Robot group

Description:

Patients undergoing robotic surgery