Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes