Rectal CancerPhase 3COLRARNCT01423214
A Trial to Assess Robot-assisted Surgery and Laparoscopy-assisted Surgery in Patients With Mid or Low Rectal Cancer
A Phase 3 study testing robot-assisted surgery and Laparoscopic surgery in people with Rectal Cancer, run by Kyungpook National University Hospital at 3 sites in South Korea.
Trial summary
This study sets up the final study end point and three detailed goals as the following. The main objective of study: This trial is done to assess the safety and benefit of robotic resection compared with conventional laparoscopy-assisted resection for curative treatment of patients with cancer of the mid or low… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- robot-assisted surgery and Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jun 2013to Dec 2018
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility rule of enrollment
- Rectal adenocarcinoma that were 10 cm or less from the anal verge
- at least 18 years old \& at most 80 years old
- Clinically diagnosed cT3N0-2 disease
- Clinical diagnosis of carcinoma involving a single rectal segment
- Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography
Who cannot join
- The presence of metastasis to the liver, lung, brain, bone, abdominal aortic lymph node, lateral pelvic wall lymph node and inguinal lymph node
- A past history of the cancer occurring in other body areas than the rectal cancer (except for a past history of the radical resection due to skin cancer)
- Severe cardiac diseases or failure
- Severe pulmonary diseases or dysfunction
- The presence of psychiatric diseases
- The concurrent presence of other severe medical diseases
- An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Gyu seog Choi
Daegu, 702-210
Jun seok Park, M.D., +82-53-200-2166, caumed5@naver.com
- Not yet recruiting
Nam Kyu Kim
Seoul, 120-752
Byung Soh Min, M.D., bsmin@yuhs.ac
- Recruiting
Seon-Hahn Kim
Seoul, 136-705
Sae Jin Baek, D.M., xezin@korea.ac.kr
About this study
This study sets up the final study end point and three detailed goals as the following.
The main objective of study: This trial is done to assess the safety and benefit of robotic resection compared with conventional laparoscopy-assisted resection for curative treatment of patients with cancer of the mid or low rectum.
Read more
Detailed goal of study:
The primary endpoint: This study is designed to assess whether robotic surgical system improves the quality of rectal cancer surgery, especially in total mesorectal excision quality and a circumferential margin positivity rate
The secondary endpoint: This study aims to compare 3- and 5-year disease-free survival and overall survival after robot and laparoscopic resection of distal rectal cancer. This study will also assess the pelvic autonomic nerve preservation, short-term morbidity, pathological quality (i.e. number of harvested lymph node), local recurrence, and blood loss during surgery.
Read the detailed description
Recently, the efficacy and oncological safety of laparoscopy has been demonstrated for treating colon cancer, and similar long-term results at 5-year confirmed by the several multicenter study trial. However, conventional laparoscopic surgery for rectal cancer is technically more difficult than colonic resection because of the confined space in the pelvis and the limitations of existing laparoscopic instruments which have a restricted range of movement compared with the provided by the surgeon's hand. Consequently, recent studies which compared short-term outcomes between open and laparoscopic rectal resections have reported higher rates of conversion to open surgery, positive circumferential margins, and increased anastomotic leakage in patients who underwent laparoscopic approach.
The da Vinci® Surgical System (Intuitive surgical, Sunnyvale, CA, USA) was introduced as the next advance in minimally invasive surgery to overcome the technical limitations of laparoscopy. The advantages of robotic assistance include enhanced dexterity, improved three-dimensional vision, and more intuitive instrument manipulation. This device eases the technical challenges of the minimally invasive approach and may make a complex surgical task more accessible to surgeons without extensive laparoscopic experience.
With its dependence on precise dissection in a narrow pelvic cavity, it is anticipated that rectal cancer surgery is one of the indications most likely to benefit from robot assistance. However, it is difficult to conclude whether robot assistance leads to better outcomes because few studies have directly compared the three existing techniques. Although robotic rectal excision has been reported to be safe and feasible in the recent literatures, a number of these results were based on small number of case series. There have been no randomized trials demonstrating the safety of robotic surgery in the treatment of rectal cancer. This study is designed to assess the efficacy and safety of robotic surgery compared with that of laparoscopic surgery for mid or low rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- robot-assisted surgery, Laparoscopic surgery
- Keywords
- rectal cancer, robot, laparoscopy, total mesorectal excision, robotic surgery
- Medical subject headings
- Rectal 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 surgeryProcedure or surgery
Conventional laparoscopic procedures
| Study group | Role | What they receive |
|---|---|---|
| Robotic LAR | Experimental | Individuals who underwent robot-assisted surgery for primary rectal cancer Receives: Procedure: robot-assisted surgery |
| Lap LAR | Active comparator | Individuals who underwent laparoscopic surgery for primary rectal cancer Receives: Procedure: Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical quality based on pathological examination
A comparison of completeness of total mesorectal excision
Measured: up to 4 weeks after operation
Secondary outcomes (5)
Postoperative morbidity
A comparison of the postoperative recovery variables, the postoperative complications and mortality
Measured: up to 30 dyas after operation
Pelvic autonomic nerve preservation (intraoperative confirmation of pelvic nerve preservation)
During procedure, a surgeon indentifies pelvic autonomic nerve and confirm whether the nerves are preserved or sacrificed.
Measured: The day of operation
Change from Baseline in QLQ 30, IIEF-5(5-item Version of the International Index of Erectile Function), IPSS(International Prostate Symptom Score), FSFI(Female Sexual Function Index), and Wexner's scoring
EORTC QLQ 30:an assessment tool for measuring the quality of life IIEF-5 : an assessment tool for measuring male erectile function IPSS : an assessment tool for measuring voiding function FSFI : an assessment tool for measuring female sexual function Wexner's scoring : an assessment tool for measuring anal sphincter function Time points : 1,3,6, and 12months after operation
Measured: up to 12months after operation
5-year overall survival rate
A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
Measured: up to 5 yearsa after operation
5-year disease-free survival rate
A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
Measured: up to 5 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startJun 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
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
- Investigators
- Gyu seog Choi, M.D, Study chair, Kyunpook National Univercity Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423214
- Sponsor's protocol ID
- KNUHCRC003
- Acronym
- COLRAR
- Status last verified
- Mar 2015
- First submitted
- 1 Aug 2011
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Song SH, Min BS, Park JS, Lee KY, Kim NK, Kim SH, Park SY, Kim HJ, Lee SM, Choi GS. Long-term oncological outcomes of robotic versus laparoscopic total mesorectal excision for rectal cancer: COLRAR randomized clinical trial. Br J Surg. 2026 Oct 5;113(10):znag114. doi: 10.1093/bjs/znag114.
PubMed 42929021
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Assess Robot-assisted Surgery and Laparoscopy-assisted Surgery in Patients With Mid or Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT01423214
- Acronym / sponsor ID
- COLRAR / KNUHCRC003
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, robot, laparoscopy, total mesorectal excision, robotic surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Aug 2011 (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.
This study sets up the final study end point and three detailed goals as the following.
The main objective of study: This trial is done to assess the safety and benefit of robotic resection compared with conventional laparoscopy-assisted resection for curative treatment of patients with cancer of the mid or low rectum.
Detailed goal of study:
The primary endpoint: This study is designed to assess whether robotic surgical system improves the quality of rectal cancer surgery, especially in total mesorectal excision quality and a circumferential margin positivity rate
The secondary endpoint: This study aims to compare 3- and 5-year disease-free survival and overall survival after robot and laparoscopic resection of distal rectal cancer. This study will also assess the pelvic autonomic nerve preservation, short-term morbidity, pathological quality (i.e. number of harvested lymph node), local recurrence, and blood loss during surgery.
Detailed description
Recently, the efficacy and oncological safety of laparoscopy has been demonstrated for treating colon cancer, and similar long-term results at 5-year confirmed by the several multicenter study trial. However, conventional laparoscopic surgery for rectal cancer is technically more difficult than colonic resection because of the confined space in the pelvis and the limitations of existing laparoscopic instruments which have a restricted range of movement compared with the provided by the surgeon's hand. Consequently, recent studies which compared short-term outcomes between open and laparoscopic rectal resections have reported higher rates of conversion to open surgery, positive circumferential margins, and increased anastomotic leakage in patients who underwent laparoscopic approach.
The da Vinci® Surgical System (Intuitive surgical, Sunnyvale, CA, USA) was introduced as the next advance in minimally invasive surgery to overcome the technical limitations of laparoscopy. The advantages of robotic assistance include enhanced dexterity, improved three-dimensional vision, and more intuitive instrument manipulation. This device eases the technical challenges of the minimally invasive approach and may make a complex surgical task more accessible to surgeons without extensive laparoscopic experience.
With its dependence on precise dissection in a narrow pelvic cavity, it is anticipated that rectal cancer surgery is one of the indications most likely to benefit from robot assistance. However, it is difficult to conclude whether robot assistance leads to better outcomes because few studies have directly compared the three existing techniques. Although robotic rectal excision has been reported to be safe and feasible in the recent literatures, a number of these results were based on small number of case series. There have been no randomized trials demonstrating the safety of robotic surgery in the treatment of rectal cancer. This study is designed to assess the efficacy and safety of robotic surgery compared with that of laparoscopic surgery for mid or low rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic LAR | Experimental | Procedure: robot-assisted surgeryIndividuals who underwent robot-assisted surgery for primary rectal cancer |
| Lap LAR | Active comparator | Procedure: Laparoscopic surgeryIndividuals who underwent laparoscopic surgery for primary rectal cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligibility rule of enrollment
- Rectal adenocarcinoma that were 10 cm or less from the anal verge
- at least 18 years old \& at most 80 years old
- Clinically diagnosed cT3N0-2 disease
- Clinical diagnosis of carcinoma involving a single rectal segment
Key exclusion criteria (7 listed)
- The presence of metastasis to the liver, lung, brain, bone, abdominal aortic lymph node, lateral pelvic wall lymph node and inguinal lymph node
- A past history of the cancer occurring in other body areas than the rectal cancer (except for a past history of the radical resection due to skin cancer)
- Severe cardiac diseases or failure
- Severe pulmonary diseases or dysfunction
- The presence of psychiatric diseases
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 | Robotic LAR |
| Laparoscopic surgeryConventional laparoscopic procedures | Procedure or surgery | Lap LAR |
Primary outcome
Surgical quality based on pathological examination
Time frame: up to 4 weeks after operation
A comparison of completeness of total mesorectal excision
5 secondary outcomes
Postoperative morbidity
Time frame: up to 30 dyas after operation
Pelvic autonomic nerve preservation (intraoperative confirmation of pelvic nerve preservation)
Time frame: The day of operation
Change from Baseline in QLQ 30, IIEF-5(5-item Version of the International Index of Erectile Function), IPSS(International Prostate Symptom Score), FSFI(Female Sexual Function Index), and Wexner's scoring
Time frame: up to 12months after operation
5-year overall survival rate
Time frame: up to 5 yearsa after operation
5-year disease-free survival rate
Time frame: up to 5 years after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Derived from this study: PubMed 42929021Song SH, Min BS, Park JS, Lee KY, Kim NK, Kim SH, Park SY, Kim HJ, Lee SM, Choi GS. Long-term oncological outcomes of robotic versus laparoscopic total mesorectal excision for rectal cancer: COLRAR randomized clinical trial. Br J Surg. 2026 Oct 5;113(10):znag114. doi: 10.1093/bjs/znag114.
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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.
Gyu seog Choi, M.D study chair
Kyunpook National Univercity Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing robot-assisted surgery and Laparoscopic surgery in people with Rectal Cancer, run by Kyungpook National University Hospital at 3 sites 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gyu-Seog Choi, M.D. (+82-53-200-2166, kyuschoi@mail.knu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical quality based on pathological examination (time frame: up to 4 weeks 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 NCT01423214, which also lists 1 linked publication.
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 11 Mar 2015.