Ureteric stent in kidney transplantation
| ISRCTN | ISRCTN89369862 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89369862 |
| Secondary identifying numbers | 8577 |
- Submission date
- 01/04/2015
- Registration date
- 02/04/2015
- Last edited
- 19/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Clare Griffin
Scientific
Scientific
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Not specified, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Umbilical vein catheter versus double J stent in renal transplantation |
| Study objectives | The current unit policy is to insert D-J stents in all the renal transplant recipients. It is then removed after 6-8 weeks in operating theatre under local anaesthetic with a Flexible Cystoscope. The aim of this study is to evaluate: 1. Increase or decrease in urological complications compared to D-J stents with particular reference to urinary tract infections, urinary leaks and obstruction. 2. The overall effective cost difference between both procedures |
| Ethics approval(s) | 08/H1002/39; First MREC approval date 05/08/2008 |
| Health condition(s) or problem(s) studied | Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders |
| Intervention | Comparison of D-J Stents |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Complications and cost 2. Increase or decrease in urological complications compared to D-J stents with particular reference |
| Secondary outcome measures | N/A |
| Overall study start date | 01/11/2008 |
| Completion date | 31/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300; UK Sample Size: 300 |
| Total final enrolment | 300 |
| Key inclusion criteria | 1. Adult patients, aged 18 years or over receiving renal transplant from deceased or live donor 2. First or retransplants 3. Patient should be able to give an informed consent 4. Lower Age Limit 18 years |
| Key exclusion criteria | 1. Ureteric damage at retrieval 2. Skeletonised ureter with doubtful blood supply 3. Thickened contracted bladder 4. Technical difficulties during surgery 5. Repeat reimplantation after leaks and fistulas 6. Simultaneous Kidney and Pancreas Transplant 7. Patient with a body mass index of greater than 32 (or whose body shape, in the opinion of the operating surgeon, is not suitable for the umbilical vein catheter) 8. Patients who have been anuric for longer than three years |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 31/03/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Manchester
M13 9WL
United Kingdom
Sponsor information
Central Manchester & Manchester Childrens University Hospital NHS Trust
Hospital/treatment centre
Hospital/treatment centre
Department of Gastroenterology
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Government
Astellas Pharma Europe
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- Astellas Pharma Europe Ltd
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 2015 results presented at the American Transplant Congress in https://atcmeetingabstracts.com/abstract/umbilical-vein-catheter-versus-double-j-stent-for-ureteric-anastomosis-in-renal-transplantation-a-single-centre-open-label-randomized-trial/ (added 19/02/2020) |
| IPD sharing plan |
Editorial Notes
19/02/2020: The following changes have been made:
1. A conference abstract has been linked in the publication and dissemination plan.
2. The final enrolment number has been added from the abstract.
11/07/2017: No publications found, verifying study status with principal investigator.
