Abstract
Background
The use of lLaparoscopic liver resection in terms of time to functional recovery, length of hospital stay (LOS), long-term abdominal wall hernias, costs and quality of life (QOL) has never been studied in a randomised controlled trial. Therefore, this is the subject of the international multicentre randomised controlled ORANGE II trial.
Methods
Patients eligible for left lateral sectionectomy (LLS) of the liver will be recruited and randomised at the outpatient clinic. All randomised patients will undergo surgery in the setting of an ERAS programme. The experimental design produces two randomised arms (open and laparoscopic LLS) and a prospective registry. The prospective registry will be based on patients that cannot be randomised because of the explicit treatment preference of the patient or surgeon, or because of ineligibility (not meeting the in- and exclusion criteria) for randomisation in this trial. Therefore, all non-randomised patients undergoing LLS will be approached to participate in the prospective registry, thereby allowing acquisition of an uninterrupted prospective series of patients. The primary endpoint of the ORANGE II trial is time to functional recovery. Secondary endpoints are postoperative LOS, percentage readmission, (liver-specific) morbidity, QOL, body image and cosmetic result, hospital and societal costs over 1 year, and long-term incidence of incisional hernias. It will be assumed that in patients undergoing laparoscopic LLS, length of hospital stay can be reduced by two days. A sample size of 55 patients in each randomisation arm has been calculated to detect a 2-day reduction in LOS (90% power and α = 0.05 (two-tailed)).
The ORANGE II trial is a multicenter randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing LLS within an enhanced recovery ERAS programme.
Trial registration
ClinicalTrials.gov NCT00874224.
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Details
1 Maastricht University Medical Centre, Department of Surgery, Maastricht, The Netherlands (GRID:grid.412966.e) (ISNI:0000 0004 0480 1382); Maastricht University Medical Centre, Clinical and Surgical Sciences, Department of Surgery, Maastricht, The Netherlands (GRID:grid.412966.e) (ISNI:0000 0004 0480 1382)
2 Maastricht University Medical Centre, Department of Surgery, Maastricht, The Netherlands (GRID:grid.412966.e) (ISNI:0000 0004 0480 1382)
3 Maastricht University Medical Centre, Department of Methodology and Statistics, Maastricht, The Netherlands (GRID:grid.412966.e) (ISNI:0000 0004 0480 1382)
4 Orbis Medical Centre, Department of Surgery, Sittard, The Netherlands (GRID:grid.416905.f)
5 Leiden University Medical Centre, Department of Surgery, Leiden, The Netherlands (GRID:grid.10419.3d) (ISNI:0000000089452978)
6 Maastricht University Medical Centre, Department of Surgery, Maastricht, The Netherlands (GRID:grid.412966.e) (ISNI:0000 0004 0480 1382); Maastricht University Medical Centre, Nutrim School for Nutrition, Toxicology and Metabolism, Maastricht, The Netherlands (GRID:grid.412966.e) (ISNI:0000 0004 0480 1382); Royal Free Hospital, Department of Surgery, London, United Kingdom (GRID:grid.426108.9) (ISNI:000000040417012X)
7 University of Northern Norway Hospital, Department of Surgery, Tromsö, Norway (GRID:grid.426108.9)
8 Maastricht University Medical Centre, Department of Surgery, Maastricht, The Netherlands (GRID:grid.412966.e) (ISNI:0000 0004 0480 1382); Maastricht University Medical Centre, Nutrim School for Nutrition, Toxicology and Metabolism, Maastricht, The Netherlands (GRID:grid.412966.e) (ISNI:0000 0004 0480 1382)