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Kumar versus Olsen clAmp for Laparoscopic cholAngiography (KOALA trial).


- candidate number8601
- NTR NumberNTR2582
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-okt-2010
- Secondary IDs2009/339 METc UMCG
- Public TitleKumar versus Olsen clAmp for Laparoscopic cholAngiography (KOALA trial).
- Scientific TitleKumar versus Olsen clAmp for Laparoscopic cholAngiography (KOALA trial).
- ACRONYMKOALA
- hypothesisIntraoperative cholangiography with the Kumar clamp is faster and easier than with the Olsen clamp.
- Healt Condition(s) or Problem(s) studiedIntraoperative cholangiography, Laparoscopic cholecystectomy
- Inclusion criteriaAdults scheduled for elective laparoscopic cholecystectomy with routine intraoperative cholangiography.
- Exclusion criteriaConversion before cholangiography takes place.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2010
- planned closingdate1-aug-2011
- Target number of participants50
- InterventionsThe intervention group will undergo intraoperative cholangiography (IOC) using the Kumar clamp.

The control group will undergo IOC using the Olsen clamp.
- Primary outcome1. Time necessary for intraoperative cholangiography (IOC), defined as the time between starting of preparation for IOC to the time that interpretation of IOC is completed;
2. Ease of the IOC procedure as measured on a visual analogue scale completed by the operator.
- Secondary outcomeThe success rate of intraoperative cholangiography defined as contrast agent observed at least in the common bile duct.
- TimepointsIntraoperative measurements and postoperative course until the first outpatient visit after discharge.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD Vincent Nieuwenhuijs
- CONTACT for SCIENTIFIC QUERIESMD Vincent Nieuwenhuijs
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryThe KOALA trial is a randomized controlled trial to compare the Kumar clamp and the Olsen clamp for intraoperative cholangiography during elective laparoscopic cholecystectomy in terms of speed and ease of the cholangiography procedure.
- Main changes (audit trail)
- RECORD29-okt-2010 - 7-nov-2010


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