No registrations found.
ID
Source
Brief title
Health condition
intraoperative cholangiography
laparoscopic cholecystectomy
intraoperatieve cholangiografie
laparoscopische cholecystectomie
Sponsors and support
Intervention
Outcome measures
Primary outcome
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;
2. Ease of the IOC procedure as measured on a visual analogue scale completed by the operator.
Secondary outcome
The success rate of intraoperative cholangiography defined as contrast agent observed at least in the common bile duct.
Background summary
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.
Study objective
Intraoperative cholangiography with the Kumar clamp is faster and easier than with the Olsen clamp.
Study design
Intraoperative measurements and postoperative course until the first outpatient visit after discharge.
Intervention
The intervention group will undergo intraoperative cholangiography (IOC) using the Kumar clamp.
The control group will undergo IOC using the Olsen clamp.
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
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
Inclusion criteria
Adults scheduled for elective laparoscopic cholecystectomy with routine intraoperative cholangiography.
Exclusion criteria
Conversion before cholangiography takes place.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2466 |
| NTR-old | NTR2582 |
| Other | METc UMCG : 2009/339 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |