Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery.

Summary

The ORANGE II trial is a double blinded randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy in terms of time to functional recovery, hospital length of stay, quality of life, readmission percentage, morbidity and mortality, hospital costs, body image and cosmesis, and long term incidence of incisional hernias.

Conditions

• Colorectal Cancer
• Liver Metastasis
• Liver Disease

Interventions

PROCEDURE

laparoscopic left lateral hepatic sectionectomy

laparoscopic left lateral hepatic sectionectomy

PROCEDURE

open left lateral hepatic sectionectomy

open left lateral hepatic sectionectomy

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Medisch Spectrum Twente

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• University Medical Center Nijmegen

  collaborator OTHER

• Onze Lieve Vrouwe Gasthuis

  collaborator OTHER

• Maxima Medical Center

  collaborator OTHER

• Isala

  collaborator OTHER

• San Raffaele University Hospital, Italy

  collaborator OTHER

• University Hospital, Aachen

  collaborator OTHER

• Deventer Ziekenhuis

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Ronald M van Dam, MD · Maastricht University Medical Centre

• Cornelis HC Dejong, MD, PhD · Maastricht University Medical Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• Netherlands

Study Locations