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Register:	ISRCTN
Last refreshed on:	26 October 2020
Main ID:	ISRCTN23941498
Date of registration:	26/01/2015
Prospective Registration:	No
Primary sponsor:	Medical University of Warsaw (Poland)
Public title:	Outcome of kidney transplantation with Bricker-type ureterointestinal anastomosis in patients with lower urinary tract dysfunction.
Scientific title:	Outcome of kidney transplantation with Bricker-type ureterointestinal anastomosis in patients with lower urinary tract infection: a observational single-centre trial
Date of first enrolment:	12/11/2014
Target sample size:	74
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN23941498
Study type:	Observational
Study design:	Observational single-centre trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
Poland

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Agnieszka Józwik
Address:	Nowogrodzka 59 02-006 Warsaw Poland
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients with lower urinary tract dysfunction who underwent kidney transplantation with Bricker-type ureterointestinal anastomosis at study center, from 1999 to 2014 (experimental group)
2. Age range 20 to 64
3. Control group - patients who had kidney transplantation and obtained a kidney from the same deceased donor as a participant from the experimental group.
4. In the case of patients, who have received a kidney from a living donor, comparisons between control and experimental group participants will be made with others that have recieved a kidney from a living donor.

Exclusion criteria: Patients who refuse their participation in this study.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Patients with end stage renal disease and lower urinary tract dysfunction who underwent kidney transplantation with Bricker-type ureterointestinal anastomosis in our center.
Urological and Genital Diseases

Intervention(s)

We will compare results of the following for experimental and control group patients:
1. Blood tests
2. Urine tests
3. Ultrasound
4. Renal scintigraphy
5. eGFR (creatinine clearace, Cocroft-Gault formula, MDRD formula, CKD - EPI formula)

Primary Outcome(s)

1. Blood tests: complete blood count, sodium, potassium, chloride, bicarbonate, blood urea nitrogen, magnesium, creatinine, glucose, calcium, lipid profile, cystatin C, C Reactive Protein, AST, ALT, bilirubin, serum albumin, vitamin B12, folic acid, transferrin, ferritin, parathormone.
2. Urine tests: routine and microscopy, cretinine, bacterial cultures.
3. Ultrasound of the abdomen and graft.
4. Renal scintigraphy.

Secondary Outcome(s)

Secondary ID(s)

N/A

Source(s) of Monetary Support

Medical University of Warsaw (Poland)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Bioethical Committee of Medical University of Warsaw, 04/11/2014, ref. KB/215/2014

Results

Results available:	Yes
Date Posted:
Date Completed:	30/09/2015
URL:

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