ArtiSential® for Rectal Cancer Surgery | NCT06236282

Studies
ArtiSential® for Rectal Cancer Surgery

NCT06236282

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Feb 1, 2024Actual

Enrollment

93Actual

Phase

Not provided

Conditions

Rectal Cancer

Interventions

ArtiSential®

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2012Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Mar 31, 2023Actual

First Submitted Date

Jan 8, 2024

First Submission Date that Met QC Criteria

Jan 23, 2024

First Posted Date

Feb 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2024

Last Update Posted Date

Feb 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ArtiSential®	Device	Articulated laparoscopic device made by Livsmed Co, South Korea.	ArtiSential® Use

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

combined surgery
recurrent rectal cancer surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided