Condition category
Urological and Genital Diseases
Date applied
01/04/2015
Date assigned
02/04/2015
Last edited
02/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Clare Griffin

ORCID ID

Contact details

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8577

Study information

Scientific title

Umbilical vein catheter versus double J stent in renal transplantation

Acronym

Study hypothesis

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.

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

08/H1002/39; First MREC approval date 05/08/2008

Study design

Randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders

Intervention

Comparison of D-J Stents

Intervention type

Device

Phase

Drug names

Primary outcome measures

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 trial start date

01/11/2008

Overall trial end date

31/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients,18 yrs 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300

Participant 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

Recruitment start date

01/11/2008

Recruitment end date

31/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

Central Manchester & Manchester Childrens University Hospital NHS Trust

Sponsor details

Department of Gastroenterology
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Astellas Pharma Europe

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

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