A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedFirst Posted
Study publicly available on registry
October 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
ExpectedOctober 6, 2022
October 1, 2022
2.3 years
September 28, 2022
October 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Surgical failure
conversion, postoperative complications, or less than 12 harvested lymph nodes
1 month
Cost
Total medical cost during hospital stay for surgery
1 month
Secondary Outcomes (2)
Oncologic outcomes
5-year
Oncologic outcomes
5-year
Study Arms (2)
ArtiSential group
Patients undergoing laparoscopic surgery using ArtiSential
Robot group
Patients undergoing robotic surgery
Interventions
Eligibility Criteria
The patients with rectal or rectosigmoid junction adenocarcinoma who will be planned to undergo elective low anterior resection with double stapled technique.
You may qualify if:
- 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
You may not qualify if:
- Preoperative systemic chemotherapy
- Distant metastasis at initial diagnosis
- Palliative surgery
- Emergent surgery
- Lynch syndrome or FAP-associated cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Asan Medical Centercollaborator
- Seoul St. Mary's Hospitalcollaborator
- Chonnam National University Hospitalcollaborator
- Severance Hospitalcollaborator
- Seoul National University Bundang Hospitalcollaborator
- Uijeongbu St. Mary Hospitalcollaborator
- LivsMedcollaborator
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
Related Publications (1)
Pyo DH, Kim S, Do M, Huh JW. Laparoscopic Ultralow Anterior Resection Using a New Articulating Device. Dis Colon Rectum. 2025 Jan 1;68(1):e5. doi: 10.1097/DCR.0000000000003287. Epub 2024 Sep 12. No abstract available.
PMID: 39264062DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 28, 2022
First Posted
October 4, 2022
Study Start
October 1, 2022
Primary Completion
December 31, 2024
Study Completion (Estimated)
December 31, 2029
Last Updated
October 6, 2022
Record last verified: 2022-10