Transplant ureteric stent removal: early versus standard removal

Completed

Conditions: rological issues in renal transplants
Urological and Genital Diseases
Urological issues

Registration Number: ISRCTN09184595

Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 176

Inclusion Criteria

1. Children aged 2 - 16 years, either sex
2. Adults aged 17 - 75 years, either sex
3. Needing kidney transplant

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stent-related complications, specifically urinary infection, pain and migration. Information collected at each OP visit for 3 months.

Secondary Outcome Measures

Name	Time	Method
1. Rate of transplant ureteric leak or stenosis: information collected at each OP visit for up to 6 months<br>2. Patient acceptability, measured with quality of life questionnaires at week 1 and week 6<br>3. Economic costs (hospital and patient): Patient diary card on day of stent removal, hospital costs can be evaluated at 6 months