ORANGE SEGMENTS: Open Versus Laparoscopic Parenchymal Preserving Postero-Superior Liver Segment Resection

Summary

The international and multicentre ORANGE SEGMENTS - Trial is a prospective, double blinded, randomized controlled study comparing patients undergoing parenchymal preserving resection of postero-superior liver segments (involving one or two of segments 4a, 7, 8). All patients will be participating in an enhanced recovery programme.

Primary outcome is time to functional recovery. Secondary study parameters include hospital length of stay, intraoperative blood loss, operation time, liver specific morbidity, readmission percentage, resection margin, quality of life, body image and cosmesis , reasons for delay of discharge after functional recovery, long term incidence of incisional hernias, hospital and societal costs during one year, time to adjuvant chemotherapy initiation, overall five-year survival.

Conditions

• Liver Surgery

Interventions

PROCEDURE

Parenchymal preserving postero-superior liver segment resection

Parenchymal preserving liver segment resection of one or two of the postero-superior liver segments (4A, 7 or 8).

Sponsors & Collaborators

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

  collaborator OTHER

• The Queen Elizabeth Hospital

  collaborator OTHER

• General Hospital Groeninge

  collaborator OTHER

• Liverpool University Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• King's College Hospital NHS Trust

  collaborator OTHER

• San Raffaele University Hospital, Italy

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• Derriford Hospital

  collaborator OTHER

• University Hospital Southampton NHS Foundation Trust

  collaborator OTHER

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• Moscow Clinical Scientific Center

  collaborator OTHER

• San Camillo Hospital, Rome

  collaborator OTHER

• Fondazione Poliambulanza Istituto Ospedaliero

  collaborator OTHER

• Federico II University

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Mohammed Abu Hilal, Prof. · University Hospital Southampton NHS Foundation Trust

• John Primrose, Prof. · University Hospital Southampton NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-01

Primary Completion

2021-11-01

Completion

2026-11-01

Countries

• Belgium
• Italy
• Netherlands
• Norway
• Russia
• United Kingdom

Study Locations