Colon CancerPhase 2NCT01042743
Laparoscopic Surgery Versus Robot Surgery for Right-side Colon Cancer: Short-term Outcome of a Randomised Clinical Trial
A Phase 2 study testing robot-assisted surgery and laparoscopic right-hemicolectomy in people with Colon Cancer, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
The recent introduction of robotic surgical system has revolutionized the field of minimally invasive surgery. The investigators hypothesized that adoption of a robotic surgical system for patients with right-side colon cancer seems appealing because This system provides high-definition three-dimensional vision… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- robot-assisted surgery and laparoscopic right-hemicolectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Dec 2011
- Phase
- Phase 2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary cancer
- right-side located tumor (from cecum to proximal transverse colon)
Who cannot join
- tumor with obstruction
- tumor with perforation
- clinically advanced tumor (T4 stage)
- tumor with distant metastases
- synchronous tumor
Trial locations and contacts
1 site in 1 country.
About this study
The recent introduction of robotic surgical system has revolutionized the field of minimally invasive surgery. The investigators hypothesized that adoption of a robotic surgical system for patients with right-side colon cancer seems appealing because This system provides high-definition three-dimensional vision, eliminates physiologic tremor, and better ergonomics. This randomized controlled trial was designed to determine the safety and efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.
- Conditions
- Colon Cancer
- Being tested
- robot-assisted surgery, laparoscopic right-hemicolectomy
- Keywords
- colon cancer, robot, laparoscopy, primary, right-side colon cancer, robot-assisted surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted surgeryProcedure or surgery
da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA)
laparoscopic right-hemicolectomyProcedure or surgery
Conventional laparoscopic procedures
| Study group | Role | What they receive |
|---|---|---|
| RAP | Experimental | individuals who underwent robot-assisted surgery for primary right-sied colon cancer Receives: Procedure: robot-assisted surgery |
| LAP | Active comparator | Individuals who underwent laparoscopic surgery for primary right-side colon cancer Receives: Procedure: laparoscopic right-hemicolectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical quality based on pathological examination
Measured: during perioperative period (1-30 days after operation)
Secondary outcomes (1)
complication
Measured: during perioperative period ( 1-30 days after primary operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gyu-Seog Choi, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042743
- Sponsor's protocol ID
- KNUHCRC001
- Status last verified
- Dec 2011
- First submitted
- 5 Jan 2010
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park JS, Lee SM, Choi GS, Park SY, Kim HJ, Song SH, Min BS, Kim NK, Kim SH, Lee KY. Comparison of Laparoscopic Versus Robot-Assisted Surgery for Rectal Cancers: The COLRAR Randomized Controlled Trial. Ann Surg. 2023 Jul 1;278(1):31-38. doi: 10.1097/SLA.0000000000005788. Epub 2023 Jan 3.
PubMed 36594748Park JS, Choi GS, Park SY, Kim HJ, Ryuk JP. Randomized clinical trial of robot-assisted versus standard laparoscopic right colectomy. Br J Surg. 2012 Sep;99(9):1219-26. doi: 10.1002/bjs.8841.
PubMed 22864881
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Surgery Versus Robot Surgery for Right-side Colon Cancer: Short-term Outcome of a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01042743
- Acronym / sponsor ID
- KNUHCRC001
- Conditions
- Colon Cancer
- Keywords
- colon cancer, robot, laparoscopy, primary, right-side colon cancer, robot-assisted surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Jan 2010 (estimated)
- 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.
The recent introduction of robotic surgical system has revolutionized the field of minimally invasive surgery. The investigators hypothesized that adoption of a robotic surgical system for patients with right-side colon cancer seems appealing because This system provides high-definition three-dimensional vision, eliminates physiologic tremor, and better ergonomics. This randomized controlled trial was designed to determine the safety and efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAP | Experimental | Procedure: robot-assisted surgeryindividuals who underwent robot-assisted surgery for primary right-sied colon cancer |
| LAP | Active comparator | Procedure: laparoscopic right-hemicolectomyIndividuals who underwent laparoscopic surgery for primary right-side colon cancer |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary cancer
- right-side located tumor (from cecum to proximal transverse colon)
Key exclusion criteria (5 listed)
- tumor with obstruction
- tumor with perforation
- clinically advanced tumor (T4 stage)
- tumor with distant metastases
- synchronous tumor
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 |
|---|---|---|
| robot-assisted surgeryda Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA) | Procedure or surgery | RAP |
| laparoscopic right-hemicolectomyConventional laparoscopic procedures | Procedure or surgery | LAP |
Primary outcome
surgical quality based on pathological examination
Time frame: during perioperative period (1-30 days after operation)
1 secondary outcome
complication
Time frame: during perioperative period ( 1-30 days after primary operation)
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 20 Dec 2011.
- Derived from this study: PubMed 36594748Park JS, Lee SM, Choi GS, Park SY, Kim HJ, Song SH, Min BS, Kim NK, Kim SH, Lee KY. Comparison of Laparoscopic Versus Robot-Assisted Surgery for Rectal Cancers: The COLRAR Randomized Controlled Trial. Ann Surg. 2023 Jul 1;278(1):31-38. doi: 10.1097/SLA.0000000000005788. Epub 2023 Jan 3.
- Derived from this study: PubMed 22864881Park JS, Choi GS, Park SY, Kim HJ, Ryuk JP. Randomized clinical trial of robot-assisted versus standard laparoscopic right colectomy. Br J Surg. 2012 Sep;99(9):1219-26. doi: 10.1002/bjs.8841.
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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?
A Phase 2 study testing robot-assisted surgery and laparoscopic right-hemicolectomy in people with Colon Cancer, run by Kyungpook 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 5 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 20 Dec 2011. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
surgical quality based on pathological examination (time frame: during perioperative period (1-30 days after operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01042743, which also lists 2 linked publications.
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 20 Dec 2011.