ArtiSential® for Rectal Cancer Surgery

Safety and Efficacy of Flexible Articulated Instrument (ArtiSential®) in Laparoscopic Surgery for Rectal Cancer

This study aimed to assess efficacy of ArtiSential® in reducing laparoscopic rectal cancer surgery duration. We retrospectively reviewed the data of patients who underwent laparoscopic low or ultralow anterior resection for primary mid-to-low rectal cancer, performed by a single surgeon in 2012-2022. Patients were divided into groups, use group vs. non-use group, based on the use or non-use of the ArtiSential®. The total mesorectal excision quality and resection margin status did not differ between the groups. ArtiSential® reduced operative time without impairing surgical quality or oncologic outcomes.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Device: ArtiSential®

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent laparoscopic resection for mid-to low rectal cancer located within 10 cm of the anal verge, performed by a single experienced surgeon between 2012 and 2022.

Description

Inclusion Criteria:

• mid-to-low rectal caner (witing 10cm of the anal verge)
• laparoscopic surgery

Exclusion Criteria:

• combined surgery
• recurrent rectal cancer surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ArtiSential® Use; Laparoscopic low anterior resection, with use of both straight devices and articulated devices	Device: ArtiSential®; Articulated laparoscopic device made by Livsmed Co, South Korea.
ArtiSential® Non-Use; Laparoscopic low anterior resection, with use of straight devices only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	To determine whether the use of articulated device can shorten total operative time	0 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term Survival	2 year recurrence free survival and 2 year overall survival	2 year
Anastomotic leakage (postop outcome)	anastomotic leakage within one month	4 weeks
TME quality (Operative outcome)	Quality of total mesorectal excision to compare quality of surgery	0 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 2208-0071346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No