Living DonorsNCT01236326

Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation

A study testing Laparoendoscopic single site donor nephrectomy and Conventional laparoscopic donor nephrectomy in people with Living Donors and Nephrectomy, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Living Donors, Nephrectomy, Kidney Transplantation
What is being tested?: Laparoendoscopic single site donor nephrectomy and Conventional laparoscopic donor nephrectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 1 siteUnited States
Study dates: Nov 2010to Oct 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

All patients scheduled to undergo laparoscopic living donor nephrectomy will be eligible for the study.

Who cannot join

There are no exclusion criteria.

Trial locations and contacts

1 site in 1 country.

United States1 site

NewYork-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065

Other trials in United States

About this study

Official title: A Randomized, Prospective, Parallel Group Study of Conventional Laparoscopic Donor Nephrectomy (LDN) Versus Laparoendoscopic Single Site Donor Nephrectomy (LESS-DN) in Living Donor Kidney Transplantation

Laparoscopic nephrectomy (removal of the kidney) is the most common procedure for people donating a kidney to be used for living donor kidney transplantation. Laparoscopic donor nephrectomy (LDN) was a great advance in the field of living donor kidney transplantation due to the many advantages it offers over open nephrectomy, including significantly shorter hospitalization and recovery time, and significantly improved cosmetic result related to the nephrectomy scar(s). More recently, a new procedure has been introduced to the field of laparoscopic nephrectomy, called laparoendoscopic single site donor nephrectomy (LESS-DN). In the LESS-DN procedure, a single natural orifice (the umbilicus or belly button) is used as the single incision site through which the entire donor nephrectomy is performed. The LESS-DN procedure may further decrease donor morbidity by further decreasing length of stay, lessening recovery time, and improving satisfaction with the surgical scar. The investigators propose to evaluate conventional LDN versus a LESS-DN in a randomized, controlled trial in living kidney donors. The investigators will compare operative times and intra-operative donor management, intra- and post-operative complications, pain scores, analgesic requirements, length of stay, recovery parameters, surgical scar satisfaction, and function and survival of the transplanted kidney for the two groups of subjects: (1) the group that has the conventional laparoscopic donor nephrectomy; and, (2) the group that has the laparoendoscopic single site donor nephrectomy.

Conditions: Living Donors, Nephrectomy, Kidney Transplantation, Surgery, Laparoscopic
Being tested: Laparoendoscopic single site donor nephrectomy, Conventional laparoscopic donor nephrectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laparoendoscopic single site donor nephrectomyProcedure or surgery
Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
Conventional laparoscopic donor nephrectomyProcedure or surgery
Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy

Study groups in NCT01236326
Study group	Role	What they receive
LESS-DN	Active comparator	Not described Receives: Procedure: Laparoendoscopic single site donor nephrectomy
Conventional LDN	Active comparator	Not described Receives: Procedure: Conventional laparoscopic donor nephrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity.
The Primary Endpoint of the Study Will be Patient Self-reported "Return to 100%", as Measured by the Number of Days Post-surgery That the Patient Reports His or Her Return to 100% Functioning Capacity.
Measured: 1 year

Secondary outcomes (4)

Days on Oral Pain Medication After Discharge
Measured: 2 months
Days Before Going Back to Work
Measured: 2 months
Days to Normal Day-to-day Activities
Measured: 2 months
Recovered by 2 Months After Donation
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Oct 2013

First posted8 Nov 2010 (estimated)
Study startNov 2010
Primary completionJun 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Living DonorsStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01236326
Sponsor's protocol ID: 1009011249
Status last verified: May 2019
First submitted: 4 Nov 2010
Last updated: 12 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Living Donors trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Prospective, Parallel Group Study of Conventional Laparoscopic Donor Nephrectomy (LDN) Versus Laparoendoscopic Single Site Donor Nephrectomy (LESS-DN) in Living Donor Kidney Transplantation
ClinicalTrials.gov ID: NCT01236326
Acronym / sponsor ID: 1009011249
Conditions: Living Donors, Nephrectomy, Kidney Transplantation, Surgery, Laparoscopic
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Study start: Nov 2010
Primary completion: Jun 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 8 Nov 2010 (estimated)
Results: Posted 26 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LESS-DN	Active comparator	Procedure: Laparoendoscopic single site donor nephrectomy
Conventional LDN	Active comparator	Procedure: Conventional laparoscopic donor nephrectomy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All patients scheduled to undergo laparoscopic living donor nephrectomy will be eligible for the study.

Key exclusion criteria (1 listed)

There are no exclusion criteria.

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
Laparoendoscopic single site donor nephrectomyPatients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy	Procedure or surgery	LESS-DN
Conventional laparoscopic donor nephrectomyPatients randomized to this arm will undergo conventional laparoscopic donor nephrectomy	Procedure or surgery	Conventional LDN

Primary outcome

The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity.
Time frame: 1 year
The Primary Endpoint of the Study Will be Patient Self-reported "Return to 100%", as Measured by the Number of Days Post-surgery That the Patient Reports His or Her Return to 100% Functioning Capacity.

4 secondary outcomes

Days on Oral Pain Medication After Discharge
Time frame: 2 months
Days Before Going Back to Work
Time frame: 2 months
Days to Normal Day-to-day Activities
Time frame: 2 months
Recovered by 2 Months After Donation
Time frame: 2 months

Results and safety

Results posted to the registry on 26 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LESS-DN	50	49
Conventional LDN	55	51

Primary outcome: The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity.

Time frame: 1 year. Mean (Standard Deviation). Unit: days

Measure	LESS-DN n = 36	Conventional LDN n = 39
Value	43 (15)	45 (22)

Population analysed: The number of participants analyzed is lower than the number of baseline participants because overall, 25% of subjects did not return the 2-month questionnaire (26.5% of the LESS-DN group and 23.5% of the Conventional LDN group).

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LESS-DN	0 of 49 (0%)	9 of 49 (18.4%)	Not reported
Conventional LDN	0 of 51 (0%)	7 of 51 (13.7%)	Not reported

Limitations and caveats (from the sponsor): Inability to secure complete data on the donor questionnaires (25% of subjects did not return 2-month questionnaire); no validated tool available to assess donor recovery and satisfaction; clinical donor follow-up was suboptimal.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 4
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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.

Joseph J Del Pizzo, M.D. principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 12 Jun 2019. 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?

Yes. Results are posted in the registry (first posted 26 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity. (time frame: 1 year). 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 NCT01236326.

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 12 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.