NCT06236282

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

10.7 years

First QC Date

January 8, 2024

Last Update Submit

January 23, 2024

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Operation time

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

    0 week

Secondary Outcomes (3)

  • Long-term Survival

    2 year

  • Anastomotic leakage (postop outcome)

    4 weeks

  • TME quality (Operative outcome)

    0 weeks

Study Arms (2)

ArtiSential® Use

Laparoscopic low anterior resection, with use of both straight devices and articulated devices

Device: ArtiSential®

ArtiSential® Non-Use

Laparoscopic low anterior resection, with use of straight devices only

Interventions

ArtiSential®DEVICE

Articulated laparoscopic device made by Livsmed Co, South Korea.

ArtiSential® Use

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • combined surgery
  • recurrent rectal cancer surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

February 1, 2024

Study Start

May 1, 2012

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

KR(1)