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

October 4, 2022 updated by: Jung Wook Huh, Samsung Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Sun Wha Kim
        • Sub-Investigator:
          • Dae Hee Pyo, MD, PhD
        • Principal Investigator:
          • Jung Wook Huh, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients with rectal or rectosigmoid junction adenocarcinoma who will be planned to undergo elective low anterior resection with double stapled technique.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ArtiSential group
Patients undergoing laparoscopic surgery using ArtiSential
Device: ArtiSential
Articulating laparoscopic instrument
Robot group
Patients undergoing robotic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical failure
Time Frame: 1 month
conversion, postoperative complications, or less than 12 harvested lymph nodes
1 month
Cost
Time Frame: 1 month
Total medical cost during hospital stay for surgery
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncologic outcomes
Time Frame: 5-year
5-year Disease-free Survival
5-year
Oncologic outcomes
Time Frame: 5-year
5-year Overall Survival
5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Seoul St. Mary's Hospital
Asan Medical Center
Chonnam National University Hospital
Seoul National University Bundang Hospital
Severance Hospital
Uijeongbu St. Mary Hospital
LivsMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2029

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-2022-01-174

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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