Evidence map›Paper›PMID 35264216›Full record

ArticleTrials2022

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 and 16 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03270917 (The ORANGE SEGMENTS - Trial), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03270917 naactive not recruitingnot on this map

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

TypeinterventionalSponsorMaastricht University Medical CenterRan2017 to 2026Enrolled250ConditionsLiver SurgeryArmsParenchymal preserving postero-superior liver segment resection
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Conversion following minimally invasive attempt at simultaneous colorectal and liver resection does not affect 30-day postoperative overall morbidity.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2025
    Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Principles of enhanced recovery in gastrointestinal surgery.Langenbeck's archives of surgery · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 19 institutions in 7 countries.

Christoph Kuemmerli *Hepatobiliary and Pancreatic Surgical Unit, University Hospital Southampton NHS Foundation Trust, Southampton, SO16 6YD, UK.
Robert S Fichtinger *Department of Surgery, Maastricht University Medical Centre+, 6202 AZ, Maastricht, The Netherlands.
Alma MoekotteHepatobiliary and Pancreatic Surgical Unit, University Hospital Southampton NHS Foundation Trust, Southampton, SO16 6YD, UK.
Luca A AldrighettiHepatobiliary Surgery Division, IRCCS San Raffaele Hospital, Milan, Italy.
Somaiah ArooriPeninsula HPB Unit, Derriford Hospital, Plymouth Hospitals NHS Trust, Plymouth, UK.
Marc G H BesselinkDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.
Mathieu D'HondtDepartment of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, Kortrijk, Belgium.
Rafael Díaz-NietoHepatobiliary Surgery Unit, Aintree University Hospital, Liverpool, UK.
Bjørn EdwinDepartment of HPB Surgery, Oslo University Hospital, Oslo, Norway.
Mikhail EfanovDepartment of Hepato-Pancreato-Biliary Surgery, Moscow Clinical Research Centre, Moscow, Russia.
Giuseppe M EttorreDivision of General Surgery and Liver Transplantation, San Camillo Hospital, Rome, Italy.
Krishna V MenonInstitute of Liver Studies, Kings College Hospital, London, UK.
Aali J SheenDepartment of Surgery, Manchester University Foundation Trust, Manchester, UK.
Zahir SoonawallaDepartment of Surgery, Oxford University Hospital NHS Foundation Trust, Oxford, UK.
Robert SutcliffeDepartment of Hepatobiliary and Pancreatic Surgery, University Hospitals Birmingham, NHS Foundation Trust, Birmingham, UK.
Roberto I TroisiDivision of HPB, Minimally Invasive and Robotic Surgery, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.
Steven A WhiteDepartment of HPB and Transplant Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
Lloyd BrandtsClinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht UMC+, Maastricht, The Netherlands.
Gerard J P van BreukelenDepartment of Methodology and Statistics, Maastricht University Medical Centre, Maastricht, The Netherlands.
Jasper SijberdenDepartment of Surgery, Foundation Poliambulanza, Via Bissolati, Brescia, Italy.
Siân A PughDepartment of Oncology, Addenbrooke's Hospital, Cambridge, UK.
Zina EmintonSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
John N PrimroseDepartment of Surgery, University of Southampton, Southampton, UK.
Ronald van DamDepartment of Surgery, Maastricht University Medical Centre+, 6202 AZ, Maastricht, The Netherlands.
Mohammed Abu HilalHepatobiliary and Pancreatic Surgical Unit, University Hospital Southampton NHS Foundation Trust, Southampton, SO16 6YD, UK. abuhilal9@gmail.com.
ORANGE trials collaborative
Maastricht University Medical Centre · NLAmsterdam University Medical Centers · NLFondazione Poliambulanza Istituto Ospedaliero · ITUniversity of Southampton · GBAddenbrooke's Hospital · GBAintree University Hospital · GBAZ Groeninge · BEDerriford Hospital · GBFederico II University Hospital · ITFreeman Hospital · GBIRCCS San Camillo Hospital · ITKing's College Hospital · GBManchester University NHS Foundation Trust · GBMoscow Clinical Scientific Center · RUOslo University Hospital · NOOxford Health NHS Foundation Trust · GBUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity Hospital Southampton NHS Foundation Trust · GBVita-Salute San Raffaele University · IT

Funding

Cancer Research UK 16248Cancer Research UK 25352Cancer Research UK C317/A16248
6 · The paper itself

Abstract

backgroundA 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, oncological 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.

methodsThe 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.

trial registrationClinicalTrials.gov NCT03270917 . Registered on September 1, 2017. Before start of inclusion. PROTOCOL VERSION: version 12, May 9, 2017.

Indexed as

HepatectomyLaparoscopyLiver NeoplasmsEquivalence Trials as TopicHumansLength of StayMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeEnhanced recoveryLaparoscopyLiver surgeryPosterosuperior segmentsRandomised controlled trial

Identifiers

PMID35264216
PMCPMC8908665
OpenAlexW4220808624

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.