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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05431049
Other study ID # 2021-8/4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 7, 2021
Est. completion date November 17, 2021

Study information

Verified date June 2022
Source Bursa City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to compare the anesthesia methods in percutaneous nephrolithotomy in terms of safety and effectiveness in elderly men.


Description:

Data recorded since 2003 will be analyzed retrospectively. Elderly men with PNL will be divided into two groups according to the type of anesthesia. The results determined in both arms will be compared with appropriate statistical methods.


Recruitment information / eligibility

Status Completed
Enrollment 184
Est. completion date November 17, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender Male
Age group 65 Years to 100 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of Renal Stone Disease - Above 65 years of age - Male sex Exclusion Criteria: - Having low hemoglobin level before surgery - Presence of hematology disease causing bleeding diathesis - Presence of stones in an ectopic or transplanted kidney

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Percutaneous nephrolithotomy surgery (PNL)
Percutaneous nephrolithotomy (PNL) surgery was performed in all arms of the study to remove the renal stones. This surgery was performed with 2 anesthesia methods, CSEA and GA. These formed the groups of the study.

Locations

Country Name City State
Turkey Bursa City Hospital Bursa

Sponsors (2)

Lead Sponsor Collaborator
Sedat Önen Bursa City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stone free rates These are the success percentages depending on the outcome of the surgical procedure in both groups. Post-surgery day 1
Primary Complication rates These are the complication percentages depending on the outcome of the surgical procedure in both groups. During surgery to 24 hours after surgery
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