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| autoid | 1 |
| crg_id | CRG050600001 |
| titleoftrial | A RANDOMIZED, CONTROLLED TRIAL OF STRAIGHT VERSUS COILED TENCKHOFF CATHETERS IN PERITONEAL DIALYSIS PATIENTS |
| acronymnoftrial | N/A |
| website | http:// |
| identificationno | N/A |
| leadprefix | Prof |
| leadsurname | Johnson |
| leadgivennames | David Wayne |
| leadposition | Director |
| leaddepartment | Department of Nephrology |
| leadorganisation | Princess Alexandra Hospital |
| leadaddress | Ipswich Road, Woolloongabba, Brisbane ,Qld 4102 Australia |
| leademail | david_johnson@health.qld.gov.au |
| leadphone | +61 7 3240 5080 |
| leadfax | +61 7 3240 5480 |
| leadsuffix | |
| contactprefix | Prof |
| contactsurname | Johnson |
| contactgivennames | David Wayne |
| contactposition | Director |
| contactdepartment | Department of Nephrology |
| contactorganisation | Princess Alexandra Hospital |
| contactaddress | Ipswich Road, Woolloongabba, Brisbane ,Qld 4102 Australia |
| contactemail | david_johnson@health.qld.gov.au |
| contactphone | +61 7 3240 5080 |
| contactfax | +61 7 3240 5480 |
| funding | other |
| otherfunding | Renal Research Trust Fund |
| fundingnameofsponsors | Queensland Health |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | June 2003 |
| actualstart | June 2003 |
| proposedcompletiondate | Dec 2006 |
| actualcompletiondate | Dec 2006 |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | Australia |
| researchquestion | Do complication rates (particularly displacement and blockage) differ between straight versus coiled Tenckhoff catheters in peritoneal dialysis patients. |
| study_status_recruitment | ongoing |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | End-stage kidney failure treated with peritoneal dialysis |
| intervention1 | Straight Tenckhoff catheter insertion |
| intervention2 | Coiled Tenckhoff catheter insertion |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 18 - no upper age limit |
| totalrecruitment | 124 |
| inclusion | 1. Patients requiring the insertion of a Tenckhoff catheter for the provision of peritoneal dialysis.
2. 18 years or over. 3. Able to give informed consent. |
| exclusion | 1. Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study. |
| primaryoutcomes | The primary outcome measures will be the frequencies of drainage failure, catheter tip migration and the need for laparoscopic repositioning of the catheter. |
| secondaryoutcomes | Secondary outcome measures will include time to first catheter-associated infection (exit site infection, tunnel infection or peritonitis), time to first catheter blockage and catheter survival. |
| reference | 1. Johnson DW. Wong J. Wiggins KJ. Kirwan R. Griffin A. Preston J. Wall D. Campbell SB. Isbel NM. Mudge DW. Hawley CM. Nicol DL. A randomized controlled trial of coiled versus straight swan-neck Tenckhoff catheters in peritoneal dialysis patients. American Journal of Kidney Diseases. 48(5):812-21, 2006 Nov. [added by Gail Higgins 20/08/2007] |