Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/11/2011
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 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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes