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

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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Procedure: Renal transplantation

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34275
    • Bakirkoy Dr Sadi Konuk Training and Research Hospital, Department of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open renal transplantation; Patients who were performed open renal transplantation due to end stage renal disease.	Procedure: Renal transplantation; Open or robot assisted renal transplantation
robot assisted renal transplantation; Patients who were performed robot assisted renal transplantation due to end stage renal disease	Procedure: Renal transplantation; Open or robot assisted renal transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Principal Investigator: Mithat Ekşi, Bakırköy Dr. Sadi Konuk Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2016
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Renal Transplantation; Quality of Life
• Other Study ID Numbers: Renal Transplantation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No