Retroperitoneoscopic Donor Nephrectomy (RDN)

October 8, 2019 updated by: Mehmet Necmettin Mercimek, Samsun Liv Hospital

Retroperitoneoscopic Donor Nephrectomy: a Retrospective Single-center Study

to compare the results of right and left-sided retroperitoneoscopic donor nephrectomy (RDN).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55020
        • Samsun Liv Hospital
      • Samsun, Turkey, 55030
        • Ondokuz Mayıs University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 57 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.).

Description

Inclusion Criteria:

  • Adult donors
  • Kidney donors undergoing retroperitoneoscopic donor nephrectomy
  • Recipients of the kidneys
  • Donors with the consent form
  • Recipients with consent form

Exclusion Criteria:

  • open donor nephrectomies
  • donors without the consent form
  • Recipients without the consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: at the end of the surgery
time from onset to complete of surgery
at the end of the surgery
Blood loss
Time Frame: at the end of the surgery
amount of bleeding during surgery (mililiter)
at the end of the surgery
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.
at the end of the surgery
İntraoperative complications
Time Frame: at the end of the surgery
abnormal problems that may be seen during surgery and require additional intervention.
at the end of the surgery
incisional hernia
Time Frame: up to 2 years
abdominal incision or trocar site defects of donors
up to 2 years
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)
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun Liv Hospital

Collaborators

Ondokuz Mayıs University

Investigators

  • Study Chair: Saban Sarıkaya, Professor, Ondokuz Mayıs University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Actual)

May 8, 2019

Study Completion (Actual)

July 22, 2019

Study Registration Dates

First Submitted

March 24, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMU KAEK (2019/79)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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