NCT03893656

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

March 24, 2019

Last Update Submit

October 8, 2019

Conditions

Transplant; Complication, Failure

Keywords

Living donor nephrectomyKindey transplantationRetroperitoneoscopic donor nephrectomyHernia

Outcome Measures

Primary Outcomes (6)

  • Operation time

    time from onset to complete of surgery

    at the end of the surgery

  • Blood loss

    amount of bleeding during surgery (mililiter)

    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.

    at the end of the surgery

  • İntraoperative complications

    abnormal problems that may be seen during surgery and require additional intervention.

    at the end of the surgery

  • incisional hernia

    abdominal incision or trocar site defects of donors

    up to 2 years

  • postoperative complication

    abnormal problems that may be seen after surgery and require additional intervention or follow-up (grade I-V)

    up to 1 month

Eligibility Criteria

Age18 Years - 57 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsun Liv Hospital

Samsun, 55020, Turkey (Türkiye)

Location

Ondokuz Mayıs University

Samsun, 55030, Turkey (Türkiye)

Location

Related Publications (3)

  • Ratner LE, Ciseck LJ, Moore RG, Cigarroa FG, Kaufman HS, Kavoussi LR. Laparoscopic live donor nephrectomy. Transplantation. 1995 Nov 15;60(9):1047-9.

    PMID: 7491680RESULT

  • Hsu 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.

    PMID: 21441855RESULT

  • Kumar 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.

    PMID: 30316352RESULT

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Saban Sarıkaya, Professor

    Ondokuz Mayıs University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, MD

Study Record Dates

First Submitted

March 24, 2019

First Posted

March 28, 2019

Study Start

February 25, 2019

Primary Completion

May 8, 2019

Study Completion

July 22, 2019

Last Updated

October 10, 2019

Record last verified: 2019-10

Locations

TU(2)