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Completed

NCT Number: NCT04435171

Comparison of Postoperative Early Period Quality of Life of Patients With Open and Robot Assisted Kidney Transplantation

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Istanbul, 34275, Turkey (Türkiye)

About this study

Patients who underwent open or robot-assisted renal transplantation at Bakirkoy Sadi Konuk Training and Research Hospital between June 2016 and December 2018 constituted the target population of this study. After application of the inclusion and exclusion criteria, the patient group was divided into two groups as per the surgical technique (i.e., open vs. robot-assisted). Demographic data, preoperative and postoperative data of all patients were collected prospectively. The quality of life of the patients was assessed preoperatively and on the postoperative 30th day

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Renal transplantation

Procedure

Open or robot assisted renal transplantation

Primary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Comparison of Postoperative Early Period Quality of Life of Patients With Open and Robot Assisted Kidney Transplantation: a Prospective Observational Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jun 17, 2020
Registry last updated
Jun 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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