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Clinical Trials/NCT05566249
NCT05566249
Recruiting
Not Applicable

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

Samsung Medical Center1 site in 1 country1,000 target enrollmentOctober 1, 2022

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
December 31, 2029
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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