ArtiSential® for Rectal Cancer Surgery

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06236282
• Other study ID #: 2208-0071346
• Status: Completed
• Start date: May 1, 2012
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• laparoscopic surgery

Exclusion Criteria:

• combined surgery

• recurrent rectal cancer surgery

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• ArtiSential®
Articulated laparoscopic device made by Livsmed Co, South Korea.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation time	To determine whether the use of articulated device can shorten total operative time	0 week
Secondary	Long-term Survival	2 year recurrence free survival and 2 year overall survival	2 year
Secondary	Anastomotic leakage (postop outcome)	anastomotic leakage within one month	4 weeks
Secondary	TME quality (Operative outcome)	Quality of total mesorectal excision to compare quality of surgery	0 weeks