Living Renal DonorNCT00460889
Renal Donor Comparison of Outcomes: Hand Assist Versus Laparoscopic Nephrectomy
An observational study of Living Renal Donor, run by Columbia University at 1 site in United States.
Trial summary
This study is designed to look at outcomes of patients who have undergone hand assisted laparoscopic donor nephrectomy versus totally laparoscopic donor nephrectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Living Renal Donor
- What is being tested?
- donor nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 2008
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Surgical clinic
Who may be able to join
- any person undergoing minimally invasive donor nephrectomy surgery at NewYork Hospital/Columbia.
Who cannot join
- any person undergoing open donor nephrectomy surgery at NewYork Hospital/Columbia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University College of Physicians and Surgeons
New York, New York, 10032
About this study
This study is designed to look at outcomes of patients who have undergone hand assisted laparoscopic donor nephrectomy versus totally laparoscopic donor nephrectomy.
- Conditions
- Living Renal Donor
- Being tested
- donor nephrectomy
- Keywords
- hand assist, laparoscopy, renal donor, outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donor nephrectomyProcedure or surgery
The objective of this protocol is to look at the outcomes of laparoscopic donor nephrectomy performed by using hand assisted (HA)or entirely laparoscopic (LDN) surgical techniques. To define the advantages of each technique, we will use records of patients who underwent laparoscopic live kidney donation with HALDN.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of postoperative comfort and hospital stay satisfaction with HALDN
Measured: 1 week
Prevalence of postoperative comfort and hospital stay satisfaction with LDN
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startOct 2006
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Principal Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Renal DonorStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis L Fowler, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460889
- Sponsor's protocol ID
- AAAB9478
- Status last verified
- Apr 2015
- First submitted
- 13 Apr 2007
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Donor Comparison of Outcomes: Hand Assist Versus Laparoscopic Nephrectomy
- ClinicalTrials.gov ID
- NCT00460889
- Acronym / sponsor ID
- AAAB9478
- Conditions
- Living Renal Donor
- Keywords
- hand assist, laparoscopy, renal donor, outcomes
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 17 Apr 2007 (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 is designed to look at outcomes of patients who have undergone hand assisted laparoscopic donor nephrectomy versus totally laparoscopic donor nephrectomy.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical clinic
Key inclusion criteria (1 listed)
- any person undergoing minimally invasive donor nephrectomy surgery at NewYork Hospital/Columbia.
Key exclusion criteria (1 listed)
- any person undergoing open donor nephrectomy surgery at NewYork Hospital/Columbia.
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 |
|---|---|---|
| donor nephrectomyThe objective of this protocol is to look at the outcomes of laparoscopic donor nephrectomy performed by using hand assisted (HA)or entirely laparoscopic (LDN) surgical techniques. To define the advantages of each technique, we will use records of patients who underwent laparoscopic live kidney donation with HALDN. | Procedure or surgery | – |
Primary outcome
Prevalence of postoperative comfort and hospital stay satisfaction with HALDN
Time frame: 1 week
Prevalence of postoperative comfort and hospital stay satisfaction with LDN
Time frame: 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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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.
Dennis L Fowler, MD principal investigator
Columbia University
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 Living Renal Donor, run by Columbia University at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 6 Apr 2015. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Prevalence of postoperative comfort and hospital stay satisfaction with HALDN (time frame: 1 week). The study lists 2 primary outcomes in all. 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 6 Apr 2015.