Localized Renal Cell CarcinomaLESSNCT00945984
Laparoendoscopic Single-site Radical Nephrectomy for Localized Renal Cell Carcinoma
An observational study of Localized Renal Cell Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Surgical resection is the only potential curative treatment available for renal cell carcinoma. The purpose of this study is to clarify the surgical and oncologic outcomes of laparoendoscopic single-site radical nephrectomy for localized Renal Cell Carcinoma. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Localized Renal Cell Carcinoma
- What is being tested?
- Radical nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to not given
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Tertiary care center
Who may be able to join
- Patients with localized renal cell carcinoma
Who cannot join
- Patients with lymph node or distant metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Laparoendoscopic Single-site Radical Nephrectomy With Conventional Laparoscopic Radical Nephrectomy for Localized Renal Cell Carcinoma
Surgical resection is the only potential curative treatment available for renal cell carcinoma. The purpose of this study is to clarify the surgical and oncologic outcomes of laparoendoscopic single-site radical nephrectomy for localized Renal Cell Carcinoma.
- Conditions
- Localized Renal Cell Carcinoma
- Being tested
- Radical nephrectomy
- Keywords
- Localized renal cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical nephrectomyProcedure or surgery
Surgical options to treat localized renal cell carcinoma
| Study group | Role | What they receive |
|---|---|---|
| LESS | Patients who underwent LESS radical nephrectomy Receives: Procedure: Radical nephrectomy | |
| Conventional laparoscopy | Patients who underwent conventional laparoscopic radical nephrectomy Receives: Procedure: Radical nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical outcomes such as operative time, estimated blood loss
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Renal Cell CarcinomaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hyeon Hoe Kim, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945984
- Sponsor's protocol ID
- LESSRNx
- Acronym
- LESS
- Status last verified
- Jul 2009
- First submitted
- 22 Jul 2009
- Last updated
- 28 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoendoscopic Single-site Radical Nephrectomy With Conventional Laparoscopic Radical Nephrectomy for Localized Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00945984
- Acronym / sponsor ID
- LESS / LESSRNx
- Conditions
- Localized Renal Cell Carcinoma
- Keywords
- Localized renal cell carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- First posted
- 24 Jul 2009 (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.
Surgical resection is the only potential curative treatment available for renal cell carcinoma. The purpose of this study is to clarify the surgical and oncologic outcomes of laparoendoscopic single-site radical nephrectomy for localized Renal Cell Carcinoma.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LESS | – | Procedure: Radical nephrectomyPatients who underwent LESS radical nephrectomy |
| Conventional laparoscopy | – | Procedure: Radical nephrectomyPatients who underwent conventional laparoscopic radical nephrectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care center
Key inclusion criteria (1 listed)
- Patients with localized renal cell carcinoma
Key exclusion criteria (1 listed)
- Patients with lymph node or distant metastasis
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 |
|---|---|---|
| Radical nephrectomySurgical options to treat localized renal cell carcinoma | Procedure or surgery | Conventional laparoscopy, LESS |
Primary outcome
Surgical outcomes such as operative time, estimated blood loss
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2009.
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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.
Hyeon Hoe Kim, PhD study chair
Seoul National University Hospital
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 Localized Renal Cell Carcinoma, 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 1 inclusion and 1 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 28 Jul 2009. 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?
Results are not available in the source record.
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 outcomes such as operative time, estimated blood loss (time frame: 1 year). 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 28 Jul 2009.