Transplant; Complication, FailureRDNNCT03893656
Retroperitoneoscopic Donor Nephrectomy
An observational study of Transplant; Complication, Failure, run by Samsun Liv Hospital at 2 sites in Turkey (Türkiye).
Trial summary
to compare the results of right and left-sided retroperitoneoscopic donor nephrectomy (RDN). Read more about this study
- Who is it for?
- Ages 18 to 57 years
- Conditions the study is for
- Transplant; Complication, Failure
- How many people
- 158 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Feb 2019to 22 Jul 2019
- 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 57 years
- All sexes
- Adult
Study population: 158 consecutive kidney donors undergoing pure RDN for allotransplantation at Ondokuz Mayıs University from January 2010 to August 2018. All operations were performed by a single surgeon (E. O.).
Who may be able to join
- Adult donors
- Kidney donors undergoing retroperitoneoscopic donor nephrectomy
- Recipients of the kidneys
- Donors with the consent form
- Recipients with consent form
Who cannot join
- open donor nephrectomies
- donors without the consent form
- Recipients without the consent form
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Samsun Liv Hospital
Samsun, 55020
Ondokuz Mayıs University
Samsun, 55030
About this study
Official title: Retroperitoneoscopic Donor Nephrectomy: a Retrospective Single-center Study
to compare the results of right and left-sided retroperitoneoscopic donor nephrectomy (RDN).
Read the detailed description
This was a retrospective study evaluating demographics, intraoperative and postoperative data of 158 kidney donors who underwent RDN from January 2010 to August 2018. Two groups were created according to the side of the surgery including Right RDN (group 1) and left RDN (group 2). The results of the recipients' were also evaluated.
- Conditions
- Transplant; Complication, Failure
- Keywords
- Living donor nephrectomy, Kindey transplantation, Retroperitoneoscopic donor nephrectomy, Hernia
- Medical subject headings
- Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
time from onset to complete of surgery
Measured: at the end of the surgery
Blood loss
amount of bleeding during surgery (mililiter)
Measured: at the end of the surgery
warm ishemia time
time from renal artery and vein dissection of the kidney to the initiation of perfusion on the bench table.
Measured: at the end of the surgery
İntraoperative complications
abnormal problems that may be seen during surgery and require additional intervention.
Measured: at the end of the surgery
incisional hernia
abdominal incision or trocar site defects of donors
Measured: up to 2 years
postoperative complication
abnormal problems that may be seen after surgery and require additional intervention or follow-up (grade I-V)
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start25 Feb 2019
- Primary completion8 May 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transplant; Complication, FailureStudies 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
- Retrospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Liv Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Principal investigator, Mehmet Necmettin Mercimek, Samsun Liv Hospital
- Investigators
- Saban Sarıkaya, Professor, Study chair, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893656
- Sponsor's protocol ID
- OMU KAEK (2019/79)
- Acronym
- RDN
- Status last verified
- Oct 2019
- First submitted
- 24 Mar 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Ratner LE, Ciseck LJ, Moore RG, Cigarroa FG, Kaufman HS, Kavoussi LR. Laparoscopic live donor nephrectomy. Transplantation. 1995 Nov 15;60(9):1047-9.
PubMed 7491680Hsu JW, Reese PP, Naji A, Levine MH, Abt PL. Increased early graft failure in right-sided living donor nephrectomy. Transplantation. 2011 Jan 15;91(1):108-14. doi: 10.1097/TP.0b013e3181fd0179.
PubMed 21441855Kumar A, Chaturvedi S, Gulia A, Maheshwari R, Dassi V, Desai P. Laparoscopic Live Donor Nephrectomy: Comparison of Outcomes Right Versus Left. Transplant Proc. 2018 Oct;50(8):2327-2332. doi: 10.1016/j.transproceed.2018.03.034. Epub 2018 Mar 16.
PubMed 30316352
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retroperitoneoscopic Donor Nephrectomy: a Retrospective Single-center Study
- ClinicalTrials.gov ID
- NCT03893656
- Acronym / sponsor ID
- RDN / OMU KAEK (2019/79)
- Conditions
- Transplant; Complication, Failure
- Keywords
- Living donor nephrectomy, Kindey transplantation, Retroperitoneoscopic donor nephrectomy, Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Samsun Liv HospitalUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 28 Mar 2019 (actual)
- 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.
to compare the results of right and left-sided retroperitoneoscopic donor nephrectomy (RDN).
Detailed description
This was a retrospective study evaluating demographics, intraoperative and postoperative data of 158 kidney donors who underwent RDN from January 2010 to August 2018. Two groups were created according to the side of the surgery including Right RDN (group 1) and left RDN (group 2). The results of the recipients' were also evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 57 years
- Sex
- All
- Age groups
- Adult
- Study population
- 158 consecutive kidney donors undergoing pure RDN for allotransplantation at Ondokuz Mayıs University from January 2010 to August 2018. All operations were performed by a single surgeon (E. O.).
Key inclusion criteria (5 listed)
- Adult donors
- Kidney donors undergoing retroperitoneoscopic donor nephrectomy
- Recipients of the kidneys
- Donors with the consent form
- Recipients with consent form
Key exclusion criteria (3 listed)
- open donor nephrectomies
- donors without the consent form
- Recipients without the consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Operation time
Time frame: at the end of the surgery
time from onset to complete of surgery
Blood loss
Time frame: at the end of the surgery
amount of bleeding during surgery (mililiter)
warm ishemia time
Time frame: at the end of the surgery
time from renal artery and vein dissection of the kidney to the initiation of perfusion on the bench table.
İntraoperative complications
Time frame: at the end of the surgery
abnormal problems that may be seen during surgery and require additional intervention.
incisional hernia
Time frame: up to 2 years
abdominal incision or trocar site defects of donors
postoperative complication
Time frame: up to 1 month
abnormal problems that may be seen after surgery and require additional intervention or follow-up (grade I-V)
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 10 Oct 2019.
- Results publication: PubMed 7491680Ratner LE, Ciseck LJ, Moore RG, Cigarroa FG, Kaufman HS, Kavoussi LR. Laparoscopic live donor nephrectomy. Transplantation. 1995 Nov 15;60(9):1047-9.
- Results publication: PubMed 21441855Hsu JW, Reese PP, Naji A, Levine MH, Abt PL. Increased early graft failure in right-sided living donor nephrectomy. Transplantation. 2011 Jan 15;91(1):108-14. doi: 10.1097/TP.0b013e3181fd0179.
- Results publication: PubMed 30316352Kumar A, Chaturvedi S, Gulia A, Maheshwari R, Dassi V, Desai P. Laparoscopic Live Donor Nephrectomy: Comparison of Outcomes Right Versus Left. Transplant Proc. 2018 Oct;50(8):2327-2332. doi: 10.1016/j.transproceed.2018.03.034. Epub 2018 Mar 16.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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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.
Saban Sarıkaya, Professor study chair
Ondokuz Mayıs University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant; Complication, Failure, run by Samsun Liv Hospital at 2 sites in Turkey (Türkiye).
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 5 inclusion and 3 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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 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?
Operation time (time frame: at the end of the surgery). The study lists 6 primary outcomes in all. 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 NCT03893656, which also lists 3 linked publications.
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 10 Oct 2019; AzTrials last refreshed its copy on 27 Oct 2026.