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Open versus laparoscopische plaatsing van de catheter gebruikt voor buikspoelingen.


- candidate number6592
- NTR NumberNTR2066
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-okt-2009
- Secondary IDsNL28836.068.09 CCMO
- Public TitleOpen versus laparoscopische plaatsing van de catheter gebruikt voor buikspoelingen.
- Scientific TitleOpen vs Laparoscopic CAPD catheter placement.
- ACRONYMCAPD-Trial
- hypothesisLaparoscopic CAPD catheter placement is superior to the open surgical approach considering the catheter survival and the incidence of short and long-term postoperative complications.
- Healt Condition(s) or Problem(s) studiedLaparoscopy, Open surgery, Peritoneal dialysis
- Inclusion criteria1. Age >18 years;
2. Randomisation by computer
3. Suitable for common CAPD catheter and in tervention strategy.
- Exclusion criteria1. No informed consent;
2. Life expectancy <1year;
3. Other intervention during same surgical procedure.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-jan-2009
- planned closingdate31-dec-2011
- Target number of participants70
- Interventions1. Open surgical CAPD catheter placement;
2. Laparoscopic CAPD catheter placement.
- Primary outcomeCatheter survival.
- Secondary outcome1. Short-term complications;
2. Long-term complications;
3. Patency of CAPD catheter.
- Timepoints1. 1 months;
2. 3 months;
3. 6 months;
4. 12 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD14-okt-2009 - 27-okt-2009


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