Rectal CancerNCT01125111
The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer
An observational study of Rectal Cancer, run by Yonsei University.
Trial summary
The clinical study of making the evidence with application of Da vinci-Robot assisted low anterior resection in rectal cancer Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- surgery(robot versus laparoscopy)
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Mar 2010
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients who visit Severance Hospital for rectal cancer
Who may be able to join
- 75 > age > 20
- Rectal cancer
- Non-distance metastasis
- Agree with this study
Who cannot join
- Benign prostate hyperplasia
- Previous history of urinary bladder or prostate gland operation
- Severe erectile dysfunction
- Defined as patients whose erectile scores were less than 10 in a preoperative questionnaire of the International Index of Erectile Function (IIEF)
About this study
The clinical study of making the evidence with application of Da vinci-Robot assisted low anterior resection in rectal cancer
- Conditions
- Rectal Cancer
- Being tested
- surgery(robot versus laparoscopy)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery(robot versus laparoscopy)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| robotic surgery group | Not described Receives: Procedure: surgery(robot versus laparoscopy) | |
| laparoscopic surgery group | Not described Receives: Procedure: surgery(robot versus laparoscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in 1 month between two surgical methods in terms of Bladder function.
The robotic surgery for rectal cancer seemed to be associated with a much earlier recovery of normal voiding and sexual function compared to those of laparoscopic surgery although it needs to be verified by larger prospective comparative studies
Measured: 1 month
Secondary outcomes (2)
The difference in 3 months between two surgical methods in tems of Sexual function.
Measured: 3 months
The serial change of Bladder and sexual function according to times, in each operation method.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startJun 2009
- Primary completionMar 2010
- Study completionMar 2010
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 Yonsei UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Nam Kyu Kim, Principal investigator, Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125111
- Sponsor's protocol ID
- 4-2009-0210
- Status last verified
- May 2010
- First submitted
- 10 May 2010
- Last updated
- 18 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer
- ClinicalTrials.gov ID
- NCT01125111
- Acronym / sponsor ID
- 4-2009-0210
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 18 May 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 clinical study of making the evidence with application of Da vinci-Robot assisted low anterior resection in rectal cancer
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic surgery group | – | Procedure: surgery(robot versus laparoscopy) |
| laparoscopic surgery group | – | Procedure: surgery(robot versus laparoscopy) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who visit Severance Hospital for rectal cancer
Key inclusion criteria (4 listed)
- 75 > age > 20
- Rectal cancer
- Non-distance metastasis
- Agree with this study
Key exclusion criteria (4 listed)
- Benign prostate hyperplasia
- Previous history of urinary bladder or prostate gland operation
- Severe erectile dysfunction
- Defined as patients whose erectile scores were less than 10 in a preoperative questionnaire of the International Index of Erectile Function (IIEF)
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 |
|---|---|---|
| surgery(robot versus laparoscopy) | Procedure or surgery | laparoscopic surgery group, robotic surgery group |
Primary outcome
The difference in 1 month between two surgical methods in terms of Bladder function.
Time frame: 1 month
The robotic surgery for rectal cancer seemed to be associated with a much earlier recovery of normal voiding and sexual function compared to those of laparoscopic surgery although it needs to be verified by larger prospective comparative studies
2 secondary outcomes
The difference in 3 months between two surgical methods in tems of Sexual function.
Time frame: 3 months
The serial change of Bladder and sexual function according to times, in each operation method.
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 18 May 2010.
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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.
Nam Kyu Kim principal investigator
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Yonsei University.
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 4 inclusion and 4 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 18 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The difference in 1 month between two surgical methods in terms of Bladder function. (time frame: 1 month). 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 18 May 2010.