Transplant ureteric stent removal: early versus standard removal

ISRCTN	ISRCTN09184595
DOI	https://doi.org/10.1186/ISRCTN09184595
Secondary identifying numbers	N/A

Submission date: 17/02/2010
Registration date: 22/04/2010
Last edited: 13/02/2017

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Jonathon Olsburgh
Scientific

Guy's Hospital
6th Floor Renal Offices
St Thomas Street
London
SE1 9RT
United Kingdom

Study information

Study design	Randomised controlled trial
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 the contact details to request a patient information sheet
Scientific title	Transplant ureteric stent removal: early versus standard removal - a randomised controlled trial
Study acronym	TrUST
Study objectives	During kidney transplantation a plastic tube (stent) is placed in the transplant ureter, between the renal pelvis and the bladder. Meta-analyses of randomised controlled trials on the use of transplant ureteric stents (TUS) have shown that routine use of a TUS reduces major post-transplant urological complications, particularly urinary leaks and ureteric stenosis. However stent complications occur in around 20% of patients, both adults and children. Studies suggest that TUS complications; which include urine infection, stent migration and pain; are related to the time stents remain in-situ. The optimum timing for stent removal is currently not known, however recent studies suggest that stents should be removed at 2 to 4 weeks post-transplantation. In our centre we have reduced the time that our ureteric stents remain in-situ from 12 to 6 weeks post-transplant on the basis of internal audit of transplant stent complications. Nevertheless, we continue to observe a 15 - 20% post transplant ureteric stent complication rate. We currently remove the stent using cystoscopy and to minimise associated risks do not advocate routinely performing the procedure before 6 weeks post-transplantation. A new technique of suturing the ureteric stent to the urethral catheter was described in 1998. This technique allows early removal of both the stent and urethral catheter together without the need for cystoscopy. We hypothesise that this new technique would enable us to remove the stent at an earlier date and reduce the complication rate associated to ureteric stents in-situ for prolonged periods.
Ethics approval(s)	London Research Ethics Committee (REC), 27/01/2010, ref: 10/H0718/5
Health condition(s) or problem(s) studied	Urological issues in renal transplants
Intervention	There are two potential study arms to which patients are allocated: Group 1: Standard technique for Transplant Ureteric Stent removal (sTUSr), or Group 2: New technique with early Transplant Ureteric Stent removal (eTUSr) A TUS is placed at the time of surgery along with a urinary catheter in all patients. Patients in the standard arm (Group 1) will have the urinary catheter removed on the ward on the 5th post-operative day. They will then undergo a cystoscopy, under either local or general anaesthetic, at week 6 to remove the TUS. Patients in the trial arm (Group 2) will have the TUS attached to the urinary catheter at the time of surgery. These patients will have the urinary catheter removed on the ward on the 5th post-operative day in the standard way. As the TUS is attached to the catheter it will be removed at the same time as removal of the catheter. This group therefore do not require cystoscopy. The study will be performed prospectively. Patients that require kidney transplantation will be recruited and allocated to a study arm. Participants of the study will be followed up in the same way as non-participants. A diary card will be completed by those in group 1 on the day of their cystoscopy. Stent related symptom assessment and quality of life questionnaires will be completed by all participants at week 1 and week 6. Data will be collected on all participants regarding ureteric complications, stent related complications, health economics and patient quality of life assessments for 3 months post-transplantation. Complications of ureteric stenosis will monitored for up to 6 months post-transplantation.
Intervention type	Procedure/Surgery
Primary outcome measure	Stent-related complications, specifically urinary infection, pain and migration. Information collected at each OP visit for 3 months.
Secondary outcome measures	1. Rate of transplant ureteric leak or stenosis: information collected at each OP visit for up to 6 months 2. Patient acceptability, measured with quality of life questionnaires at week 1 and week 6 3. Economic costs (hospital and patient): Patient diary card on day of stent removal, hospital costs can be evaluated at 6 months
Overall study start date	01/04/2010
Completion date	15/12/2015

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	88 patients per group (176 patients in total)
Key inclusion criteria	1. Children aged 2 - 16 years, either sex 2. Adults aged 17 - 75 years, either sex 3. Needing kidney transplant
Key exclusion criteria	1. Urinary Tract exclusion: 1.1. Urinary diversion e.g. ileal conduit, cutaneous ureterostomy, mitrofanoff 1.2. Duplex transplant ureter 1.3. Pelviureteric junction obstruction 1.4. Surgical concern regarding the vascularity of the transplant ureter 1.5. Donor kidney stone and use of bench (ex-vivo) ureteroscopy 1.6. Early use of mammalian target of rapamycin (mTOR) inhibitors (early use is very uncommon as the drug has well documented concerns regarding worse tissue healing) 2. Risk of bleeding: 2.1. Kidney capsule removed at retrieval 2.2. Need for post-operative systemic heparinisation 2.3. Greater than 3 cycles of pre-operative plasma exchange (DFFP) as part of transplant desensitisation program 3. Simultaneous kidney and pancreas transplant (SPK)
Date of first enrolment	27/05/2010
Date of final enrolment	22/11/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Guy's Hospital

London
SE1 9RT
United Kingdom

Sponsor information

Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Jennifer Boston
Guy's Hospital
2nd Floor Conybeare House
St Thomas Street
London
SE1 9RT
England
United Kingdom

Phone	+44 (0)20 7188 5736
Email	Jennifer.boston@gstt.nhs.uk
Website	http://www.guysandstthomas.nhs.uk/
"ROR"	https://ror.org/00j161312

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-0909-20047) - grant pending, outcome due July 2010

No information available

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	The results are expected to be published in early 2016
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version v2	14/12/2010	28/09/2016	No	No
Results article	results	01/08/2017		Yes	No

Additional files

ISRCTN09184595_PROTOCOL_v2_14Dec10.pdf: - Protocol (not peer reviewed) uploaded 28/09/2016

Editorial Notes

13/02/2017: Publication reference added.

28/09/2016: Changed overall end date from 01/10/2012 to 15/12/2015. Changed recruitment start date from 01/04/2010 to 27/05/2010. Changed recruitment end date from 01/10/2012 to 22/11/2013. Uploaded protocol (not peered reviewed