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Kumar clamp versus Olsen cAtheter for Laparoscopic intraoperative cholAngiography (KOALA)

Kumar clamp versus Olsen cAtheter for Laparoscopic intraoperative cholAngiography (KOALA) - KOALA (kumar versus Olsen)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34943
Enrollment
50
Registered
2010-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholelithiasis gall stones

Interventions

Patients in both arms of the study will undergo laparoscopic cholecystectomy using the standard critical view of safety technique. Patients in the control arm will undergo IOC in the standard manner

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-70 with an indication for laparoscopic cholecystectomy with intraoperative cholangiography.

Exclusion criteria

Exclusion criteria: Malignancies of the gallbladder.

Design outcomes

Primary

MeasureTime frame
The main endpoint of the study is the time necessary for IOC, defined as the time from insertion of the instrument for cystic ductotomy (control arm) or the Kumar clamp (intervention arm) to the time that the x-ray arm is rolled out of the operative field.

Secondary

MeasureTime frame
The secondary endpoint is the surgeon's judgement of the ease of the procedure (measured by questionnaire).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)