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Gouden Galsteen Studie.


- candidate number8624
- NTR NumberNTR2587
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-nov-2010
- Secondary IDsGouden_Galsteen_UMCG_1 UMCG
- Public TitleGouden Galsteen Studie.
- Scientific TitleDocumenting the 'critical view of safety': Photograph or video.
- ACRONYMGouden Galsteen Studie
- hypothesisVideo images are superior to photographs in conclusively documenting the 'critical view of safety' during laparoscopic cholecystectomy.
- Healt Condition(s) or Problem(s) studiedLaparoscopic cholecystectomy
- Inclusion criteria1. >17 years old;
2. Laparoscopic cholecystectomy.
- Exclusion criteriaConversion before the 'critical view of safety' is reached.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 5-nov-2010
- planned closingdate4-mei-2011
- Target number of participants80
- InterventionsThree photographs will be taken of the CVS according to a predefined protocol.
Two video's will be taken of the CVS according to a predefined protocol.
- Primary outcomeConclusiveness of the 'critical view of safety' as judged by a panel of GI surgeons.
- Secondary outcomeN/A
- TimepointsIntraoperative only.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. H.S. Hofker
- CONTACT for SCIENTIFIC QUERIESMD. PhD. H.S. Hofker
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryAll patients of 18 years and older that undergo laparoscopic cholecystectomy will be included. Three photographs and two video's will be taken of the 'critical view of safety'. The photographs and video's will later be judged by a panel of GI surgeons on conclusiveness of documentation of the 'critical view of safety'.
- Main changes (audit trail)
- RECORD4-nov-2010 - 19-nov-2010


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