Evidence map›Paper›PMID 36316075›Full record

ArticleBMJ open2022

Minimally invasivE versus open total GAstrectomy (MEGA): study protocol for a multicentre randomised controlled trial (DRKS00025765).

Felix Nickel, Alexander Studier-Fischer, David Hausmann, Rosa Klotz, Sophia Lara Vogel-Adigozalov, Solveig Tenckhoff, Christina Klose, Manuel Feisst, Samuel Zimmermann, Benjamin Babic and 18 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.0field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. 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

28 authors at 14 institutions in 2 countries.

Felix Nickel *Department of General, Visceral and Transplantation Surgery, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.
Alexander Studier-Fischer *Department of General, Visceral and Transplantation Surgery, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.
David HausmannDepartment of General, Visceral and Transplantation Surgery, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.ORCID 0000-0002-0571-4710
Rosa KlotzDepartment of General, Visceral and Transplantation Surgery, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.
Sophia Lara Vogel-AdigozalovDepartment of General, Visceral and Transplantation Surgery, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.ORCID 0000-0002-6100-2371
Solveig TenckhoffDepartment of General, Visceral and Transplantation Surgery, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.
Christina KloseInstitute of Medical Biometry and Informatics, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.
Manuel FeisstInstitute of Medical Biometry, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.
Samuel ZimmermannInstitute of Medical Biometry, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.
Benjamin BabicDepartment of General, Visceral and Tumor and Transplantation Surgery, University Hospital Cologne, Koln, Germany.ORCID 0000-0003-0313-6862
Felix BerltDepartment of General, Visceral and Transplantation Surgery, Johannes Gutenberg University Hospital Mainz, Mainz, Germany.
Christiane BrunsDepartment of General, Visceral and Tumor and Transplantation Surgery, University Hospital Cologne, Koln, Germany.
Ines GockelDepartment of Visceral, Transplantation, Thoracic and Vascular Surgery, Universitatsklinikum Leipzig, Leipzig, Germany.
Sandra GrafDepartment of General and Visceral Surgery, University Hospital Ulm, Ulm, Germany.
Peter GrimmingerDepartment of General, Visceral and Transplantation Surgery, Johannes Gutenberg University Hospital Mainz, Mainz, Germany.
Christian A GutschowDepartment of Visceral and Transplantation Surgery, University Hospital Zurich, Zurich, Switzerland.
Jens HoeppnerDepartment of Surgery, University Medical Center Schleswig Holstein Lübeck Campus, Lübeck, Germany.
Kaja LudwigDepartment of General, Visceral, Thoracic and Vascular Surgery, Klinikum Sudstadt Rostock, Rostock, Germany.
Lutz MirowDepartment of General and Visceral Surgery, Klinikum Chemnitz gGmbH, Chemnitz, Germany.
Stefan MönigDepartment of Digestive Surgery, Geneva University Hospitals, Geneva, Switzerland.
Daniel ReimDepartment of Surgery, University Hospital Munich, Munchen, Germany.
Florian SeyfriedDepartment of General, Visceral, Transplant, Vascular and Pediatric Surgery, Central Würzburg Hospital, Wurzburg, Germany.
Daniel StangeDepartment of Visceral, Thoracic and Vascular Surgery, Technische Universität Dresden, Dresden, Germany.
Adrian BilleterDepartment of General, Visceral and Transplantation Surgery, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.
Henrik NienhüserDepartment of General, Visceral and Transplantation Surgery, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.
Pascal ProbstDepartment of Surgery, Kantonsspital Frauenfeld, Frauenfeld, Switzerland.ORCID 0000-0002-0895-4015
Thomas SchmidtDepartment of General, Visceral and Tumor and Transplantation Surgery, University Hospital Cologne, Koln, Germany.
Beat Peter Müller-StichDepartment of General, Visceral and Transplantation Surgery, UniversitätsKlinikum Heidelberg, Heidelberg, Germany BeatPeter.Mueller@med.uni-heidelberg.de.ORCID 0000-0002-8552-8538
Heidelberg University · DEGerman Society of Surgery · DEUniversity Hospital Cologne · DEJohannes Gutenberg University Mainz · DEKantonsspital Frauenfeld · CHKlinikum Chemnitz · DEKlinikum Südstadt Rostock · DEMünchen Klinik · DETechnische Universität Dresden · DEUniversitätsklinikum Würzburg · DEUniversity Hospital Leipzig · DEUniversity Hospital of Geneva · CHUniversity Hospital of Zurich · CHUniversity Hospital Ulm · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe only curative treatment for most gastric cancer is radical gastrectomy with D2 lymphadenectomy (LAD). Minimally invasive total gastrectomy (MIG) aims to reduce postoperative morbidity, but its use has not yet been widely established in Western countries. Minimally invasivE versus open total GAstrectomy is the first Western multicentre randomised controlled trial (RCT) to compare postoperative morbidity following MIG vs open total gastrectomy (OG). METHODS AND ANALYSIS: This superiority multicentre RCT compares MIG (intervention) to OG (control) for oncological total gastrectomy with D2 or D2+LAD. Recruitment is expected to last for 2 years. Inclusion criteria comprise age between 18 and 84 years and planned total gastrectomy after initial diagnosis of gastric carcinoma. Exclusion criteria include Eastern Co-operative Oncology Group (ECOG) performance status >2, tumours requiring extended gastrectomy or less than total gastrectomy, previous abdominal surgery or extensive adhesions seriously complicating MIG, other active oncological disease, advanced stages (T4 or M1), emergency setting and pregnancy.The sample size was calculated at 80 participants per group. The primary endpoint is 30-day postoperative morbidity as measured by the Comprehensive Complications Index. Secondary endpoints include postoperative morbidity and mortality, adherence to a fast-track protocol and patient-reported quality of life (QoL) scores (QoR-15, EUROQOL EuroQol-5 Dimensions-5 Levels (EQ-5D), EORTC QLQ-C30, EORTC QLQ-STO22, activities of daily living and Body Image Scale). Oncological endpoints include rate of R0 resection, lymph node yield, disease-free survival and overall survival at 60-month follow-up. ETHICS AND DISSEMINATION: Ethical approval has been received by the independent Ethics Committee of the Medical Faculty, University of Heidelberg (S-816/2021) and will be received from each responsible ethics committee for each individual participating centre prior to recruitment. Results will be published open access. TRIAL REGISTRATION NUMBER: DRKS00025765.

Indexed as

LaparoscopyStomach NeoplasmsAdolescentAdultAgedAged, 80 and overDisease-Free SurvivalEquivalence Trials as TopicGastrectomyHumansLymph Node ExcisionMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeYoung Adultgastrointestinal tumoursoncologysurgery

Identifiers

PMID36316075
PMCPMC9628650
OpenAlexW4307697669

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.