Intraoperative cholangiography with the Kumar clamp is faster and easier than with the Olsen clamp.
ID
Bron
Verkorte titel
Aandoening
intraoperative cholangiography
laparoscopic cholecystectomy
intraoperatieve cholangiografie
laparoscopische cholecystectomie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. 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;<br>
2. Ease of the IOC procedure as measured on a visual analogue scale completed by the operator.
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
Intraoperative cholangiography with the Kumar clamp is faster and easier than with the Olsen clamp.
Onderzoeksopzet
Intraoperative measurements and postoperative course until the first outpatient visit after discharge.
Onderzoeksproduct en/of interventie
The intervention group will undergo intraoperative cholangiography (IOC) using the Kumar clamp.
The control group will undergo IOC using the Olsen clamp.
Publiek
Vincent Nieuwenhuijs
University Medical Center Groningen, Department of Surgery, Division of Abdominal Surgery
Groningen 9700 RB
The Netherlands
+31 (0)50 3616161
v.b.nieuwenhuijs@chir.umcg.nl
Wetenschappelijk
Vincent Nieuwenhuijs
University Medical Center Groningen, Department of Surgery, Division of Abdominal Surgery
Groningen 9700 RB
The Netherlands
+31 (0)50 3616161
v.b.nieuwenhuijs@chir.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Adults scheduled for elective laparoscopic cholecystectomy with routine intraoperative cholangiography.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Conversion before cholangiography takes place.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2466 |
| NTR-old | NTR2582 |
| Ander register | METc UMCG : 2009/339 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |