NCT04435171

Brief Summary

The investigators aimed to investigate the quality of life in patients with end-stage renal disease who underwent open or robot-assisted renal transplantation. Also, the investigators sought to determine the parameters which can affect the quality of life in these patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

June 15, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

2.5 years

First QC Date

May 22, 2020

Last Update Submit

June 17, 2020

Conditions

Keywords

End Stage Renal DiseaseRenal TransplantationQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Percentage of change for Quality of Life (measure : Short Form 36) after open and robot assisted renal transplantation

    Percentage of change for quality of life (measure : Short Form 36) for patients who performed open and robot assisted renal transplantation due to end stage renal disease. Scores of the Short Form-36 Health Survey vary between 0 and 100, a score of 0 corresponds to the lowest quality, while 100 indicates the highest quality.

    From just before the treatment and up to 30 days after the surgery was performed

Study Arms (2)

Open renal transplantation

Patients who were performed open renal transplantation due to end stage renal disease.

Procedure: Renal transplantation

robot assisted renal transplantation

Patients who were performed robot assisted renal transplantation due to end stage renal disease

Procedure: Renal transplantation

Interventions

Open or robot assisted renal transplantation

Open renal transplantationrobot assisted renal transplantation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were performed open or robot assisted renal transplantation due to End Stage Renal Disease

You may qualify if:

  • Patients aged between 18 and 75
  • Who were diagnosed with End Stage Renal Disease (i.e., estimated glomerular filtration rate loer than 20 ml/minute or symptomatic uremia or dialysis requirement)
  • Received a kidney from a live donor

You may not qualify if:

  • Patients with mental retardation, dementia, and psychotic or cognitive disorders, including delirium
  • Patients who underwent deceased renal transplantation and who underwent simple bilateral nephrectomy or any other surgical procedure concurrent with Open renal transplantation
  • Patients who died or had graft failure during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr Sadi Konuk Training and Research Hospital, Department of Urology

Istanbul, 34275, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsOrgan TransplantationTransplantationSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Mithat Ekşi

    Bakırkoy Dr. Sadi Konuk Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2020

First Posted

June 17, 2020

Study Start

June 15, 2016

Primary Completion

December 15, 2018

Study Completion

May 20, 2020

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations