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

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04435171
Collaborator
(none)
129
1
47.1
2.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
129 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Postoperative Early Period Quality of Life of Patients With Open and Robot Assisted Kidney Transplantation: a Prospective Observational Study
Actual Study Start Date :
Jun 15, 2016
Actual Primary Completion Date :
Dec 15, 2018
Actual Study Completion Date :
May 20, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bakirkoy Dr Sadi Konuk Training and Research Hospital, Department of Urology Istanbul Turkey 34275

Sponsors and Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Principal Investigator: Mithat Ekşi, Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT04435171
Other Study ID Numbers:
  • Renal Transplantation
First Posted:
Jun 17, 2020
Last Update Posted:
Jun 19, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study Results

No Results Posted as of Jun 19, 2020