Contact information
Type
Scientific
Primary contact
Mr S Sudhindran
ORCID ID
Contact details
Box No 210
Transplant Unit
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)7623 851784
sudhindran@bigfoot.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0544093499
Study information
Scientific title
Acronym
Study hypothesis
Laparoscopic versus closed insertion of peritoneal dialysis catheters
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Peritoneal dialysis
Intervention
Patients 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 type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/09/2000
Overall trial end date
11/09/2003
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
100 patients (PROJ)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
11/09/2000
Recruitment end date
11/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Box No 210
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Cambridge Consortium - Addenbrooke's (UK)
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