Condition category
Urological and Genital Diseases
Date applied
01/11/2014
Date assigned
26/01/2015
Last edited
26/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Kidney transplantation is the best treatment for kidney failure but for patients with lower urinary tract (bladder and urethra) dysfunction (for example, due to an infection), it is often impossible perform that surgery in a classic way. A Bricker-type ureterointestinal anastomosis (a tube connecting the ureter to the small intestine) is a widely used technique for performing ureteroenteric anastomosis (a technique for diverting the flow of urine from its normal route) in these cases. Here, we want to investigate how well patients do having undergone a Bricker-type ureterointestinal anastomosis during their kidney transplant compared to patients who have a classic kidney transplant

Who can participate?
Adults (aged 20-64) with lower urinary tract dysfunction that underwent a kidney transplantation with Bricker-type ureterointestinal anastomosis from 1999 to 2014 (experimental group). A control group consisting of participants who have had a classic kidney transplant, receiving either the second kidney of a deceased donor from which a participant from the experimental group has been given the first, or a kidney from a living donor is also recruited. In the case of patients whose kidney is from living donor, comparisons are made with people in the experimental group who have also received a kidney from a living donor.

What does the study involve?
Participants are invited to our hospital, where they undergo an examination and a number of tests (blood tests, urine tests, ultrasound, renal scintigraphy). The results from the experimental group are then compared to those of the control group.

What are the possible benefits and risks of participating?
All participants will be given the results of our tests. If we find some disorders or abnormalities we will try to treat them. The risk to participants is close to zero.

Where is the study run from?
Department of General and Transplantation Surgery of Infant Jesus Hospital in Warsaw (Poland)

When is the study starting and how long is it expected to run for?
November 2014 to September 2015.

Who is funding the study?
Medical University of Warsaw (Poland)

Who is the main contact?
Agnieszka Jóźwik
agniechaaj@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Miss Agnieszka Jóźwik

ORCID ID

Contact details

Nowogrodzka 59
Warsaw
02-006
Poland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Outcome of kidney transplantation with Bricker-type ureterointestinal anastomosis in patients with lower urinary tract infection: a observational single-centre trial

Acronym

N/A

Study hypothesis

Study hypothesis is that outcome of kidney transplantation with Bricker-type ureterointestinal anastomosis, is as good as outcome of kidney transplantation with normal urinary drainage. There is the same kidney function, number of complications after transplantation, graft and patient survival.

Ethics approval

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

Study design

Observational single-centre trial

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Intervention

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)

Intervention type

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

N/A

Overall trial start date

12/11/2014

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

74 (37 patients that have undergone kidney transplantation with Bricker-type ureterointestinal anastomosis and 37 patients that have undergone kidney transplantation with normal urinary drainage).

Participant exclusion criteria

Patients who refuse their participation in this study.

Recruitment start date

12/11/2014

Recruitment end date

30/09/2015

Locations

Countries of recruitment

Poland

Trial participating centre

Nowogrodzka 59
Warsaw
02-006
Poland

Sponsor information

Organisation

Medical University of Warsaw (Poland)

Sponsor details

Żwirki i Wigury 61
Warsaw
02-091
Poland

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Medical University of Warsaw (Poland)

Alternative name(s)

Medical University of Warsaw, WUM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Poland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes