Comparison of Postoperative Early Period Quality of Life of Patients With Open and Robot Assisted Kidney Transplantation
1 other identifier
observational
129
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2020
CompletedFirst Submitted
Initial submission to the registry
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 17, 2020
CompletedJune 19, 2020
June 1, 2020
2.5 years
May 22, 2020
June 17, 2020
Conditions
Keywords
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.
robot assisted renal transplantation
Patients who were performed robot assisted renal transplantation due to end stage renal disease
Interventions
Open or robot assisted renal transplantation
Eligibility Criteria
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)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mithat Ekşi
Bakırkoy Dr. Sadi Konuk Training and Research Hospital
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