Evidence map›Paper›PMID 39232781›Full record

ArticleTrials2024

Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial.

K Keywani, W J Eshuis, A B J Borgstein, M J van Det, P van Duijvendijk, B van Etten, P P Grimminger, J Heisterkamp, S M Lagarde, M D P Luyer and 12 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05180864 (Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT05180864 narecruitingnot on this map

Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

TypeinterventionalSponsorAmsterdam UMCRan2024 to 2031Enrolled654ConditionsStomach NeoplasmArmsGastrectomy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

22 authors.

K KeywaniAmsterdam UMC Location, Department of Surgery, Amsterdam, the Netherlands.
W J EshuisAmsterdam UMC Location, Department of Surgery, Amsterdam, the Netherlands.
A B J BorgsteinAmsterdam UMC Location, Department of Surgery, Amsterdam, the Netherlands.
M J van DetZiekenhuis Groep Twente, Department of Surgery, Almelo, the Netherlands.
P van DuijvendijkGelre Ziekenhuis, Department of Surgery, Apeldoorn, the Netherlands.
B van EttenDepartment of Surgery, Universitair Medisch Centrum Groningen, Groningen, the Netherlands.
P P GrimmingerDepartment of General, Visceral and Transplant Surgery, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
J HeisterkampDepartment of Surgery, Elisabeth Tweesteden Ziekenhuis, Tilburg, the Netherlands.
S M LagardeDepartment of Surgery, Erasmus Medisch Centrum, Rotterdam, the Netherlands.
M D P LuyerDepartment of Surgery, Catharina Ziekenhuis, Eindhoven, the Netherlands.
S R MarkarNuffield Department of Surgery, University of Oxford, Oxford, UK.
S L MeijerAmsterdam UMC location University of Amsterdam, Department of Pathology, Amsterdam, the Netherlands.
J P E N PierieDepartment of Surgery, Medisch Centrum Leeuwarden, Leeuwarden, the Netherlands.
F RovielloDepartment of Surgery, Azienda Ospedaliera Universitaria, Siena, Italy.
J P RuurdaUniversitair Medisch Centrum Utrecht, Department of Surgery, Utrecht, the Netherlands.
J W van SandickThe Netherlands Cancer Institute - Antoni van Leeuwenhoek, Department of Surgery, Amsterdam, the Netherlands.
M SosefDepartment of Surgery, Zuyderland ziekenhuis, Heerlen, the Netherlands.
B P L WittemanDepartment of Surgert, Rijnstate Ziekenhuis, Arnhem, the Netherlands.
W O de SteurDepartment of Surgery, Leids Universitair Medisch Centrum, Leiden, the Netherlands.
B I Lissenberg-WitteDepartment of Epidemiology and Data Science, VU University Amsterdam, Amsterdam, the Netherlands.
M I van Berge HenegouwenAmsterdam UMC Location, Department of Surgery, Amsterdam, the Netherlands.
S S GisbertzAmsterdam UMC Location, Department of Surgery, Amsterdam, the Netherlands. s.s.gisbertz@amsterdamumc.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPotentially curative therapy for locally advanced gastric cancer consists of gastrectomy, usually in combination with perioperative chemotherapy. An oncological resection includes a radical (R0) gastrectomy and modified D2 lymphadenectomy; generally, a total omentectomy is also performed, to ensure the removal of possible microscopic disease. However, the omentum functions as a regulator of regional immune responses to prevent infections and prevents adhesions which could lead to bowel obstructions. Evidence supporting a survival benefit of routine complete omentectomy during gastrectomy is lacking.

methodsOMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Eligible patients are operable (ASA < 4) and have resectable (≦ cT4aN3bM0) primary gastric cancer. Patients will be 1:1 randomized between (sub)total gastrectomy with omentum preservation distal of the gastroepiploic vessels versus complete omentectomy. For a power of 80%, the target sample size is 654 patients. The primary objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of 3-year overall survival. Secondary endpoints include intra- and postoperative outcomes, such as blood loss, operative time, hospital stay, readmission rate, quality of life, disease-free survival, and cost-effectiveness. DISCUSSION: The OMEGA trial investigates if omentum preservation during gastrectomy for gastric cancer is non-inferior to complete omentectomy in terms of 3-year overall survival, with non-inferiority being determined based on results from both the intention-to-treat and the per-protocol analyses. The OMEGA trial will elucidate whether routine complete omentectomy could be omitted, potentially reducing overtreatment.

trial registrationClinicalTrials.gov NCT05180864. Registered on 6

Indexed as

Equivalence Trials as TopicGastrectomyMulticenter Studies as TopicOmentumStomach NeoplasmsAdultAgedDisease-Free SurvivalFemaleHumansLymph Node ExcisionMaleMiddle AgedOrgan Sparing TreatmentsQuality of LifeRandomized Controlled Trials as TopicGastric cancerOmentectomyRandomized controlled trialSurvival

Identifiers

PMID39232781
PMCPMC11375919

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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.