Outcome of kidney transplantation with Bricker-type ureterointestinal anastomosis in patients with lower urinary tract dysfunction.
| ISRCTN | ISRCTN23941498 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23941498 |
| Protocol serial number | N/A |
| Sponsor | Medical University of Warsaw (Poland) |
| Funder | Medical University of Warsaw (Poland) |
- Submission date
- 01/11/2014
- Registration date
- 26/01/2015
- Last edited
- 15/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Nowogrodzka 59
Warsaw
02-006
Poland
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational single-centre trial |
| Secondary study design | Single-centre |
| Study type | Participant information sheet |
| Scientific title | Outcome of kidney transplantation with Bricker-type ureterointestinal anastomosis in patients with lower urinary tract infection: a observational single-centre trial |
| Study acronym | N/A |
| Study objectives | 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(s) | Bioethical Committee of Medical University of Warsaw, 04/11/2014, ref. KB/215/2014 |
| 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. |
| 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 | Other |
| Primary outcome measure(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. |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 30/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 74 |
| Key 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. |
| Key exclusion criteria | Patients who refuse their participation in this study. |
| Date of first enrolment | 12/11/2014 |
| Date of final enrolment | 30/09/2015 |
Locations
Countries of recruitment
- Poland
Study participating centre
02-006
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/10/2020: No publications found.
