Contact information
Type
Scientific
Primary contact
Mr Sudhanshu Chitale
ORCID ID
Contact details
Department of Urology
Norfolk and Norwich University Hospital NHS Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom
+44
sudhanshu.chitale@nnuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0547147994
Study information
Scientific title
Acronym
Study hypothesis
Is performing percutaneous renal surgery without leaving a tube drain in the kidney postoperatively as safe as with the placement of a postop drain? Our hypothesis is that, in selected cases, it is not only as safe but also associated with reduced postoperative morbidity and hospital stay.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Renal
Intervention
Comparison of two different approaches to keyhole surgery of the kidney with stone disease.
Added 26 August 2008: trial stopped due to poor recruitment and lack of funding.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Postoperatve blood loss, postoperative incidence of infection and urinary leak (urinoma).
Secondary outcome measures
Analgesic requirement, hospital stay, readmission rates.
Overall trial start date
01/09/2003
Overall trial end date
01/09/2005
Reason abandoned
Lack of funding & poor recruitment
Eligibility
Participant inclusion criteria
Adults with small-moderate size pelvicalyceal stones.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
115 in each arm = 230
Participant exclusion criteria
Patients with complete stones, solitary functioning kidney, renal insufficiency
Recruitment start date
01/09/2003
Recruitment end date
01/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Urology
Norwich
NR4 7UY
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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