ArtiSential® for Rectal Cancer Surgery

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

combined surgery
recurrent rectal cancer surgery

Treatment and study plan

ArtiSential®

Device

Articulated laparoscopic device made by Livsmed Co, South Korea.

Primary outcomes

Operation time

Time frame: 0 week

To determine whether the use of articulated device can shorten total operative time

Secondary outcomes

Long-term Survival

Time frame: 2 year

2 year recurrence free survival and 2 year overall survival
Anastomotic leakage (postop outcome)

Time frame: 4 weeks

anastomotic leakage within one month
TME quality (Operative outcome)

Time frame: 0 weeks

Quality of total mesorectal excision to compare quality of surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2022
Study completion: 2023
First posted: Feb 1, 2024
Registry last updated: Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed