NCT05566249
Recruiting
Not Applicable
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- Samsung Medical Center
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Cost
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Jung Wook Huh
Professor
Samsung Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Cost
Time Frame: 1 month
Total medical cost during hospital stay for surgery
Surgical failure
Time Frame: 1 month
conversion, postoperative complications, or less than 12 harvested lymph nodes
Secondary Outcomes
- Oncologic outcomes(5-year)
Study Sites (1)
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