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

Recruiting

• Conditions: Rectal Cancer; Rectosigmoid Cancer; Rectosigmoid Junction Cancer
• Interventions: Device: ArtiSential

• Registration Number: NCT05566249
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-30
• Status Verified: 2022-10
• Study Start: 2022-10-01
• Study First Posted: 2022-10-04
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-06
• Primary Completion: 2024-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ArtiSential group	ArtiSential	Patients undergoing laparoscopic surgery using ArtiSential

Primary Outcome Measures

Name	Time	Method
Surgical failure	1 month	conversion, postoperative complications, or less than 12 harvested lymph nodes
Cost	1 month	Total medical cost during hospital stay for surgery

Secondary Outcome Measures

Name	Time	Method
Oncologic outcomes	5-year	5-year Overall Survival

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of