Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Perioperative morbidity

Outcome Description:

This study aims to compare major intraoperative and postoperative parameters in patients randomized to either laparoscopic or open liver resection. Pre- and perioperative events relevant for surgical outcomes will be registered. The following intraoperative parameters will be compared: operative time, blood loss, blood transfusion, while intraoperative incidents will be classified according to the Satava classification. Morbidity will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al.

Outcome Time Frame:

Within 4 months after surgery

Safety Issue:

Yes

Principal Investigator

Bjørn Edwin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Oslo University Hospital - The Interventional Centre

Authority:

Norway:National Committee for Medical and Health Research Ethics

Study ID:

2011/1285/REK sør-øst B

NCT ID:

NCT01516710

Start Date:

January 2012

Completion Date:

December 2014

Related Keywords:

• Secondary Malignant Neoplasm of Liver
• Colorectal Neoplasms
• Open liver resection
• Laparoscopic liver resection
• Colorectal cancer liver metastases
• Neoplasms
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary