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ACTIVE NOT RECRUITING
NCT03270917
NA

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

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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.

Official title: The ORANGE SEGMENTS - Trial: an International Multicentre Randomized Controlled Trial of Open Versus Laparoscopic Parenchymal Preserving Postero-superior Liver Segment Resection

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2017-11-01

Completion Date

2026-11-01

Last Updated

2025-05-19

Healthy Volunteers

No

Conditions

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).

Locations (16)

General Hospital Groeninge

Kortrijk, Belgium

Poliambulanza Hospital

Brescia, Italy

San Raffaele Hospital

Milan, Italy

San Camillo-Forlanini Hospital

Rome, Italy

Academic Medical Center

Amsterdam, Netherlands

Maastricht University Medical Center+

Maastricht, Netherlands

University Hospital Oslo

Oslo, Norway

Moscow Clinical Scientific Center

Moscow, Russia

Aintree University Hospital

Aintree, United Kingdom

Queen Elizabeth Hospital

Birmingham, United Kingdom

King's College Hospital

London, United Kingdom

Manchester Royal Infirmary

Manchester, United Kingdom

Freeman Hospital

Newcastle, United Kingdom

Oxford University Hospitals

Oxford, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

University Hospital Southampton

Southampton, United Kingdom