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Surgical technique for continuous ambulant peritoneal dialysis catheter insertion: Laparoscopic or Open Catheter Insertion?


- candidate number27076
- NTR NumberNTR6372
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-apr-2017
- Secondary IDsNL48474.078.14 MEC-2015-277
- Public TitleSurgical technique for continuous ambulant peritoneal dialysis catheter insertion: Laparoscopic or Open Catheter Insertion?
- Scientific TitleSurgical technique for continuous ambulant peritoneal dialysis catheter insertion: Laparoscopic or Open Catheter Insertion?
- ACRONYMThe LOCI 2 Study
- hypothesisLaparoscopic catheter insertion is better than open catheter insertion for peritoneal dialysis
- Healt Condition(s) or Problem(s) studiedRenal disease, Peritoneal dialysis
- Inclusion criteria- ESRD patient with an indication for CAPD
- 18 years or older
- Exclusion criteria- Patients younger than 18 years
- Mental retardation
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jun-2015
- planned closingdate31-dec-2017
- Target number of participants254
- InterventionsLaparoscopic catheter insertion
Open catheter insertion
- Primary outcomeIs there a difference in incidence at 1 year postoperatively in malfunctioning CAPD-catheters comparing the laparoscopic insertion and open insertion technique?
- Secondary outcomeAre there differences in catheter longevity and the rate of surgical complications, mortality, leakage, catheter migration, re-admissions, exit-site infections, peritonitis and duration of hospital stay comparing the laparoscopic and open technique? Does the quality of life and the scale of postoperative pain differ between both techniques?
- TimepointsPreoperative
Postoperative
Day 0
Day 1
Day 2
Day 3
Start CAPD-training
Year 1
- Trial web sitewww.locitrial.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Nuts/Ohra
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD12-apr-2017 - 19-jun-2017


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