Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II – Trial): study protocol for a randomised controlled trial

Abstract

BackgroundThe 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.MethodsPatients 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 registrationClinicalTrials.gov NCT00874224.

The effect of enhanced recovery program for patients undergoing partial laparoscopic hepatectomy of liver cancer

“…When patients cannot be blinded to their treatment allocation they may be resentful if they do not receive their wished treatment, and therefore they may have poor compliance [13]. On the opposite, patients having their wished treatment may have pleasant compliance.…”

“…Ever since Reich first performed laparoscopic hepatectomy for benign liver cancer in 1991, laparoscopic hepatectomy is still a difficult surgery with high risks nowadays, due to the uncontrolled bleeding, air embolism and the potential for malignant planting. Recently, there are retrospective case reviews indicating that laparoscopic hepatectomy is safe for both malignant and benign liver lesions [12,13]. The safety and feasibility of laparoscopy for minor liver resections has been previously demonstrated.…”

Bleeding control during laparoscopic liver resection: a review of literature

“…Indeed, to date no randomized trial has been published on that matter. However, an international trial is being prepared [58] and should highlight the specific effect of LLR on bleeding control.…”

Fast-Track Programs

“…No report exists in the literature specifi cally addressing the topic of fast-track surgery in patients with benign disease nor outcome in terms of quality of life and cosmetic results after laparoscopic surgery. Despite this, interesting results will be provided by ORANGE II trial [ 18 ] that was developed to provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy and participating in an enhanced recovery program in terms of time to functional recovery, hospital length of stay, readmission percentage, morbidity (liver-specifi c), quality of life, body image, hospital costs, and the incidence of incisional hernias.…”