Prospective randomised trial of laparoscopic versus closed insertion of Tenckhoff catheters for peritoneal dialysis access

ISRCTN ISRCTN87054124
DOI https://doi.org/10.1186/ISRCTN87054124
Secondary identifying numbers N0544093499
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
22/11/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr S Sudhindran
Scientific

Box No 210
Transplant Unit
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Phone +44 (0)7623 851784
Email sudhindran@bigfoot.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesLaparoscopic versus closed insertion of peritoneal dialysis catheters
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPeritoneal dialysis
InterventionPatients who are admitted to Addenbrooke's Hospital for insertion of peritoneal dialysis catheters will be randomised to undergo the procedure by one of the two methods:
1. Percutaneous closed insertion under local anaesthesia in the ward
2. Laparoscopic insertion under general anaesthesia in the main operating theatre

The failure rates and complications of the two procedures will be compared. Both these techniques are normally done in this hospital. The only additional requirement from the patient is consent for randomisation.

Trial stopped due to poor recruitment.
Intervention typeProcedure/Surgery
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date11/09/2000
Completion date11/09/2003
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants100
Key inclusion criteria100 patients (PROJ)
Key exclusion criteriaNot provided at time of registration
Date of first enrolment11/09/2000
Date of final enrolment11/09/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Box No 210
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Cambridge Consortium - Addenbrooke's (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan