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

Completed

• Conditions: Quality of Life
• Interventions: Procedure: Renal transplantation

• Registration Number: NCT04435171
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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

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 Timeline

• Study Start: 2016-06-15
• Primary Completion: 2018-12-15
• Study Completion: 2020-05-20
• Study First Submitted: 2020-05-22
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-17
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open renal transplantation	Renal transplantation	Patients who were performed open renal transplantation due to end stage renal disease.
robot assisted renal transplantation	Renal transplantation	Patients who were performed robot assisted renal transplantation due to end stage renal disease

Primary Outcome Measures

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

Trial Locations

Locations (1)

Bakirkoy Dr Sadi Konuk Training and Research Hospital, Department of Urology; 🇹🇷 Istanbul, Turkey