TumorLapVsOpen prtnNCT01093079
Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes
An observational study of Tumor and Nephrectomy, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Partial Nephrectomy is the standard care for small (<4 cm) renal tumors. Despite the expanding use of laparoscopic approach, debate exist regarding the short and long term outcomes compared to the open approach. Our goal is to perform a prospective randomized trial to compare these methods Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Nephrectomy, Laparoscopy
- What is being tested?
- Laparoscopic partial nephrectomy and Open partial nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to partial nephrectomy due to renal lesion , suspected to be a tumor
Who may be able to join
- patients referred to partial nephrectomy
Who cannot join
- Contra-indication for laparocopic surgery
- Complexed , large tumors, single kidney, chronic renal failure
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin medical center
Petah Tikva
shay golan, MD, 972-50-3447573, shaygo1@yahoo.com
About this study
Partial Nephrectomy is the standard care for small (<4 cm) renal tumors. Despite the expanding use of laparoscopic approach, debate exist regarding the short and long term outcomes compared to the open approach. Our goal is to perform a prospective randomized trial to compare these methods
- Conditions
- Tumor, Nephrectomy, Laparoscopy
- Being tested
- Laparoscopic partial nephrectomy, Open partial nephrectomy
- Keywords
- Renal tumor, RCC, Partial nephrectomy, Laparoscopy
- Medical subject headings
- Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic partial nephrectomyProcedure or surgery
Laparoscopic partial nephrectomy
Open partial nephrectomyProcedure or surgery
Open partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic partial nephrectomy | Not described Receives: Procedure: Laparoscopic partial nephrectomy | |
| Open Partial nephrectomy | Not described Receives: Procedure: Open partial nephrectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093079
- Sponsor's protocol ID
- 5489
- Acronym
- LapVsOpen prtn
- Status last verified
- Jul 2009
- First submitted
- 24 Mar 2010
- Last updated
- 25 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes
- ClinicalTrials.gov ID
- NCT01093079
- Acronym / sponsor ID
- LapVsOpen prtn / 5489
- Conditions
- Tumor, Nephrectomy, Laparoscopy
- Keywords
- Renal tumor, RCC, Partial nephrectomy, Laparoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- First posted
- 25 Mar 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.
Partial Nephrectomy is the standard care for small (<4 cm) renal tumors. Despite the expanding use of laparoscopic approach, debate exist regarding the short and long term outcomes compared to the open approach. Our goal is to perform a prospective randomized trial to compare these methods
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic partial nephrectomy | – | Procedure: Laparoscopic partial nephrectomy |
| Open Partial nephrectomy | – | Procedure: Open partial nephrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to partial nephrectomy due to renal lesion , suspected to be a tumor
Key inclusion criteria (1 listed)
- patients referred to partial nephrectomy
Key exclusion criteria (2 listed)
- Contra-indication for laparocopic surgery
- Complexed , large tumors, single kidney, chronic renal failure
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 |
|---|---|---|
| Laparoscopic partial nephrectomyLaparoscopic partial nephrectomy | Procedure or surgery | Laparoscopic partial nephrectomy |
| Open partial nephrectomyOpen partial nephrectomy | Procedure or surgery | Open Partial nephrectomy |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 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.
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 Tumor and Nephrectomy, run by Rabin Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 25 Mar 2010. 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 Israel. 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?
Contact Shay Golan, MD (972-50-7447573, shaygo1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 25 Mar 2010.