Rectal CancerNCT06236282
ArtiSential® for Rectal Cancer Surgery
An observational study of Rectal Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- ArtiSential®
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2012to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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.
Who may be able to join
- mid-to-low rectal caner (witing 10cm of the anal verge)
- laparoscopic surgery
Who cannot join
- combined surgery
- recurrent rectal cancer surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rectal Cancer
- Being tested
- ArtiSential®
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtiSential®Device
Articulated laparoscopic device made by Livsmed Co, South Korea.
| Study group | Role | What they receive |
|---|---|---|
| ArtiSential® Use | Laparoscopic low anterior resection, with use of both straight devices and articulated devices Receives: Device: ArtiSential® | |
| ArtiSential® Non-Use | Laparoscopic low anterior resection, with use of straight devices only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
To determine whether the use of articulated device can shorten total operative time
Measured: 0 week
Secondary outcomes (3)
Long-term Survival
2 year recurrence free survival and 2 year overall survival
Measured: 2 year
Anastomotic leakage (postop outcome)
anastomotic leakage within one month
Measured: 4 weeks
TME quality (Operative outcome)
Quality of total mesorectal excision to compare quality of surgery
Measured: 0 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 May 2012
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236282
- Sponsor's protocol ID
- 2208-0071346
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Flexible Articulated Instrument (ArtiSential®) in Laparoscopic Surgery for Rectal Cancer
- ClinicalTrials.gov ID
- NCT06236282
- Acronym / sponsor ID
- 2208-0071346
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ArtiSential® Use | – | Device: ArtiSential®Laparoscopic low anterior resection, with use of both straight devices and articulated devices |
| ArtiSential® Non-Use | – | –Laparoscopic low anterior resection, with use of straight devices only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (2 listed)
- mid-to-low rectal caner (witing 10cm of the anal verge)
- laparoscopic surgery
Key exclusion criteria (2 listed)
- combined surgery
- recurrent rectal cancer surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArtiSential®Articulated laparoscopic device made by Livsmed Co, South Korea. | Device | ArtiSential® Use |
Primary outcome
Operation time
Time frame: 0 week
To determine whether the use of articulated device can shorten total operative time
3 secondary outcomes
Long-term Survival
Time frame: 2 year
Anastomotic leakage (postop outcome)
Time frame: 4 weeks
TME quality (Operative outcome)
Time frame: 0 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: 0 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.