Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial

Christoph Kuemmerli, Robert S Fichtinger, Alma Moekotte, Luca A Aldrighetti, Somaiah Aroori, Marc G H Besselink, Mathieu D'Hondt, Rafael Díaz-Nieto, Bjørn Edwin, Mikhail Efanov, Giuseppe M Ettorre, Krishna V Menon, Aali J Sheen, Zahir Soonawalla, Robert Sutcliffe, Roberto I Troisi, Steven A White, Lloyd Brandts, Gerard J. P. van Breukelen, Jasper SijberdenSiân A Pugh, Zina Eminton, John N Primrose, Ronald van Dam, Mohammed Abu Hilal*, ORANGE Trials Collaborative

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

1 Citation (Web of Science)

Abstract

Background: A shift towards parenchymal-sparing liver resections in open and laparoscopic surgery emerged in the last few years. Laparoscopic liver resection is technically feasible and safe, and consensus guidelines acknowledge the laparoscopic approach in the posterosuperior segments. Lesions situated in these segments are considered the most challenging for the laparoscopic approach. The aim of this trial is to compare the postoperative time to functional recovery, complications, ontological safety, quality of life, survival and costs after laparoscopic versus open parenchymal-sparing liver resections in the posterosuperior liver segments within an enhanced recovery setting.Methods: The ORANGE Segments trial is an international multicentre randomised controlled superiority trial conducted in centres experienced in laparoscopic liver resection. Eligible patients for minor resections in the posterosuperior segments will be randomised in a 1:1 ratio to undergo laparoscopic or open resections in an enhanced recovery setting. Patients and ward personnel are blinded to the treatment allocation until postoperative day 4 using a large abdominal dressing.The primary endpoint is time to functional recovery. Secondary endpoints include intraoperative outcomes, length of stay, resection margin, postoperative complications, 90-day mortality, time to adjuvant chemotherapy initiation, quality of life and overall survival.Laparoscopic liver surgery of the posterosuperior segments is hypothesised to reduce time to functional recovery by 2 days in comparison with open surgery. With a power of 80% and alpha of 0.04 to adjust for interim analysis halfway the trial, a total of 250 patients are required to be randomised.Discussion: The ORANGE Segments trial is the first multicentre international randomised controlled study to compare short- and long-term surgical and oncological outcomes of laparoscopic and open resections in the posterosuperior segments within an enhanced recovery programme.
Original languageEnglish
Article number206
Pages (from-to)1-11
Number of pages11
JournalTrials
Volume23
Issue number1
DOIs
Publication statusPublished - 9 Mar 2022

Keywords

  • Hepatectomy/adverse effects
  • Humans
  • Laparoscopy/adverse effects
  • Length of Stay
  • Liver Neoplasms/surgery
  • Multicenter Studies as Topic
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • SURGERY
  • PROGNOSTIC-FACTORS
  • Enhanced recovery
  • SEVERITY GRADING SYSTEM
  • METASTASES
  • Laparoscopy
  • BODY-IMAGE
  • Liver surgery
  • Posterosuperior segments
  • DIFFICULTY
  • HEPATOCELLULAR-CARCINOMA
  • Randomised controlled trial
  • PARENCHYMAL-SPARING RESECTIONS
  • QUALITY-OF-LIFE
  • CLINICAL-OUTCOMES

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