Rectal Cancer Clinical Trial
Official title:
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2029 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center | Asan Medical Center, Chonnam National University Hospital, LivsMed, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Severance Hospital, Uijeongbu St. Mary Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical failure | conversion, postoperative complications, or less than 12 harvested lymph nodes | 1 month | |
Primary | Cost | Total medical cost during hospital stay for surgery | 1 month | |
Secondary | Oncologic outcomes | 5-year Disease-free Survival | 5-year | |
Secondary | Oncologic outcomes | 5-year Overall Survival | 5-year |
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