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Recruiting Observational

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

NCT05566249 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2022-10-01
Last updated
2022-10-06

Condition(s) studied

Rectal CancerRectosigmoid CancerRectosigmoid Junction Cancer

Investigational drug(s) / intervention(s)

ArtiSential

ArtiSential: Articulating laparoscopic instrument

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05566249 on ClinicalTrials.gov ↗ ← All trials in South Korea