title: Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).
abstract: BACKGROUND
  For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy.
  
  
  METHODS
  The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness.
  
  
  CONCLUSIONS
  In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.
  
  
  BACKGROUND
  NCT02248519.
authors.affiliation: University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. Leonie.Haverkamp@gmail.com.
authors.forename: Leonie
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authors.lastname: Haverkamp
authors.affiliation: University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. H.J.F.Brenkman@umcutrecht.nl.
authors.forename: Hylke J F
authors.initials: HJ
authors.lastname: Brenkman
authors.affiliation: University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. M.F.J.Seesing@umcutrecht.nl.
authors.forename: Maarten F J
authors.initials: MF
authors.lastname: Seesing
authors.affiliation: Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. S.S.Gisbertz@amc.uva.nl.
authors.forename: Suzanne S
authors.initials: SS
authors.lastname: Gisbertz
authors.affiliation: Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. M.I.vanBergeHenegouwen@amc.uva.nl.
authors.forename: Mark I
authors.initials: MI
authors.lastname: van Berge Henegouwen
authors.affiliation: Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. Misha.Luyer@catharinaziekenhuis.nl.
authors.forename: Misha D P
authors.initials: MD
authors.lastname: Luyer
authors.affiliation: Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. Grard.Nieuwenhuijzen@catharinaziekenhuis.nl.
authors.forename: Grard A P
authors.initials: GA
authors.lastname: Nieuwenhuijzen
authors.affiliation: Erasmus Medical Center, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands. B.Wijnhoven@erasmusmc.nl.
authors.forename: Bas P L
authors.initials: BP
authors.lastname: Wijnhoven
authors.affiliation: Erasmus Medical Center, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands. J.vanLanschot@erasmusmc.nl.
authors.forename: Jan J B
authors.initials: JJ
authors.lastname: van Lanschot
authors.affiliation: Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands. W.O.deSteur@lumc.nl.
authors.forename: Wobbe O
authors.initials: WO
authors.lastname: de Steur
authors.affiliation: Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands. H.H.Hartgrink@lumc.nl.
authors.forename: Henk H
authors.initials: HH
authors.lastname: Hartgrink
authors.affiliation: Zuyderland Medical Center, Dr. H. van der Hoffplein 1, 6162 BG Sittard-Geleen, The Netherlands. J.Stoot@orbisconcern.nl.
authors.forename: Jan H M B
authors.initials: JH
authors.lastname: Stoot
authors.affiliation: Zuyderland Medical Center, Dr. H. van der Hoffplein 1, 6162 BG Sittard-Geleen, The Netherlands. K.Hulsewe@orbisconcern.nl.
authors.forename: Karel W E
authors.initials: KW
authors.lastname: Hulsewé
authors.affiliation: Rijnstate Hospital, Wagnerlaan 55, 6815AD , Arnhem, The Netherlands. ESpillenaarBilgen@rijnstate.nl.
authors.forename: Ernst J
authors.initials: EJ
authors.lastname: Spillenaar Bilgen
authors.affiliation: Rijnstate Hospital, Wagnerlaan 55, 6815AD , Arnhem, The Netherlands. JRutter@rijnstate.nl.
authors.forename: Jeroen E
authors.initials: JE
authors.lastname: Rütter
authors.affiliation: ZGT Hospitals, location Almelo, Zilvermeeuw 1, 7609 PP, Almelo, The Netherlands. E.Kouwenhoven@zgt.nl.
authors.forename: Ewout A
authors.initials: EA
authors.lastname: Kouwenhoven
authors.affiliation: ZGT Hospitals, location Almelo, Zilvermeeuw 1, 7609 PP, Almelo, The Netherlands. M.vDet@zgt.nl.
authors.forename: Marc J
authors.initials: MJ
authors.lastname: van Det
authors.affiliation: VU University Medical Center, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands. DL.vanderPeet@vumc.nl.
authors.forename: Donald L
authors.initials: DL
authors.lastname: van der Peet
authors.affiliation: VU University Medical Center, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands. F.Daams@vumc.nl.
authors.forename: Freek
authors.initials: F
authors.lastname: Daams
authors.affiliation: Meander Medical Center, Maatweg 3, 3813 TZ, Amersfoort, The Netherlands. WA.Draaisma@meandermc.nl.
authors.forename: Werner A
authors.initials: WA
authors.lastname: Draaisma
authors.affiliation: Meander Medical Center, Maatweg 3, 3813 TZ, Amersfoort, The Netherlands. IAMJ.Broeders@meandermc.nl.
authors.forename: Ivo A M J
authors.initials: IA
authors.lastname: Broeders
authors.affiliation: University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. H.vanStel@umcutrecht.nl.
authors.forename: Henk F
authors.initials: HF
authors.lastname: van Stel
authors.affiliation: University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. M.M.Lacle@umcutrecht.nl.
authors.forename: Miangela M
authors.initials: MM
authors.lastname: Lacle
authors.affiliation: University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. J.P.Ruurda@umcutrecht.nl.
authors.forename: Jelle P
authors.initials: JP
authors.lastname: Ruurda
authors.affiliation: University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. R.vanHillegersberg@umcutrecht.nl.
authors.forename: Richard
authors.initials: R
authors.lastname: van Hillegersberg
mesh_terms: D000230:Adenocarcinoma / Q000191:economics / Q000473:pathology / Q000601:surgery*; D003362:Cost-Benefit Analysis; D005743:Gastrectomy / Q000191:economics / Q000379:methods*; D006801:Humans; D010535:Laparoscopy / Q000191:economics / Q000379:methods*; D007902:Length of Stay / Q000191:economics / Q000706:statistics & numerical data; D009426:Netherlands; D011183:Postoperative Complications / Q000191:economics / Q000453:epidemiology; D011446:Prospective Studies; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000191:economics / Q000473:pathology / Q000601:surgery*; D016019:Survival Analysis; D016896:Treatment Outcome