Evidence map›Paper›PMID 38087139›Full record

Trial reportAnnals of surgical oncology2024

A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial).

Maurizio Degiuli, Aridai H Resendiz Aguilar, Mario Solej, Danila Azzolina, Giulia Marchiori, Francesco Corcione, Umberto Bracale, Roberto Peltrini, Maria M Di Nuzzo, Gianandrea Baldazzi and 14 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIEquivalence TrialMulticenter Study
In one paragraph

Trial report in Annals of surgical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04871399 (Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for the Right Colon Cancer), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
6.0field-weighted citation impact, top 3% 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.

NCT04871399 narecruitingnot on this map

Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for the Right Colon Cancer: An Italian Randomized Trial

TypeinterventionalSponsorUniversity of Turin, ItalyRan2020 to 2027Enrolled416ConditionsColon CancerArmsConventional Right hemicolectomy (Non-CME), Right hemicolectomy with CME+CVL
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 10 institutions in 1 country.

Maurizio DegiuliDivision of Surgical Oncology and Digestive Surgery, Department of Oncology, San Luigi University Hospital, University of Turin, Orbassano (Turin), Italy.
Aridai H Resendiz AguilarDivision of Surgical Oncology and Digestive Surgery, Department of Oncology, San Luigi University Hospital, University of Turin, Orbassano (Turin), Italy.
Mario SolejDivision of Surgical Oncology and Digestive Surgery, Department of Oncology, San Luigi University Hospital, University of Turin, Orbassano (Turin), Italy.
Danila AzzolinaDepartment of Environmental and Preventive Sciences, University of Ferrara, Via Fossato di Mortara, Ferrara, Italy.
Giulia MarchioriDepartment of Surgical Sciences, University of Turin, Turin, Italy.
Francesco CorcioneChirurgia Oncologica e Miniinvasiva Clinica Mediterranea Napoli, University of Naples Federico II, Naples, Italy.
Umberto BracaleMinimally Invasive, General and Oncologic Surgery Unit, University Federico II of Naples, Naples, Italy.
Roberto PeltriniMinimally Invasive, General and Oncologic Surgery Unit, University Federico II of Naples, Naples, Italy.
Maria M Di NuzzoMinimally Invasive, General and Oncologic Surgery Unit, University Federico II of Naples, Naples, Italy.
Gianandrea BaldazziASST Ovest Milanese, P.O. Nuovo Ospedale di Legnano, Legnano, Italy.
Diletta CassiniASST Ovest Milanese, P.O. Nuovo Ospedale di Legnano, Legnano, Italy.
Giuseppe S SicaMinimally Invasive and Gastrointestinal Surgery Unit, Università e Policlinico Tor Vergata, Rome, Italy.
Brunella PirozziMinimally Invasive and Gastrointestinal Surgery Unit, Università e Policlinico Tor Vergata, Rome, Italy.
Andrea MuratoreSurgical Department, Edoardo Agnelli Hospital, Pinerolo, Italy.
Marcello CalabròSurgical Department, Edoardo Agnelli Hospital, Pinerolo, Italy.
Elio JovineIRCCS AOU of Bologna, University of Bologna, Bologna, Italy.
Raffaele LombardiAOU of Bologna, Bologna, Italy.
Gabriele AnaniaDipartimento Scienze Mediche, Università di Ferrara, Ferrara, Italy.
Matteo ChiozzaDipartimento Scienze Mediche, Università di Ferrara, Ferrara, Italy.
Wanda PetzDigestive Surgery, European Institute of Oncology-IRCCS, Milan, Italy.
Paolo PizziniDigestive Surgery, European Institute of Oncology-IRCCS, Milan, Italy.
Roberto PersianiFondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Alberto BiondiFondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Rossella ReddavidDivision of Surgical Oncology and Digestive Surgery, Department of Oncology, San Luigi University Hospital, University of Turin, Orbassano (Turin), Italy. rossella.reddavid@unito.it.ORCID http://orcid.org/0000-0003-0603-9953
University of Turin · ITUniversity of Ferrara · ITUniversity of Naples Federico II · ITAzienda Ospedaliera Ospedale Civile di Legnano · ITEuropean Institute of Oncology · ITOspedale Civile Edoardo Agnelli · ITPoliclinico Tor Vergata · ITUniversità Cattolica del Sacro Cuore · ITClinica Mediterranea · ITUniversity of Bologna · IT

Funding

Università degli Studi di Torino SOLM_RILO_18_01
6 · The paper itself

Abstract

backgroundAlthough complete mesocolic excision (CME) is supposed to be associated with a higher lymph node (LN) yield, decreased local recurrence, and survival improvement, its implementation currently is debated because the evidence level of these data is rather low and still not supported by randomized controlled trials.

methodThis is a multicenter, randomized, superiority trial (NCT04871399). The 3-year disease-free survival (DFS) was the primary end point of the study. The secondary end points were safety (duration of operation, perioperative complications, hospital length of stay), oncologic outcomes (number of LNs retrieved, 3- and 5-year overall survival, 5-year DFS), and surgery quality (specimen length, area and integrity rate of mesentery, length of ileocolic and middle-colic vessels). The trial design required the LN yield to be higher in the CME group at interim analysis.

resultsInterim data analysis is presented in this report. The study enrolled 258 patients in nine referral centers. The number of LNs retrieved was significantly higher after CME (25 vs. 20; p = 0.012). No differences were observed with respect to intra- or post-operative complications, postoperative mortality, or duration of surgery. The hospital stay was even shorter after CME (p = 0.039). Quality of surgery indicators were higher in the CME arm of the study. Survival data still were not available.

conclusionsInterim data show that CME for right colon cancer in referral centers is safe and feasible and does not increase perioperative complications. The study documented with evidence that quality of surgery and LN yield are higher after CME, and this is essential for continuation of patient recruitment and implementation of an optimal comparison. Trial registration The trial was registered at ClinicalTrials.gov with the code NCT04871399 and with the acronym CoME-In trial.

Indexed as

Colonic NeoplasmsLaparoscopyMesocolonSurgical OncologyColectomyHumansItalyLymph Node ExcisionTreatment OutcomeCentral vascular ligationComplete mesocolic excisionEmbryological plane dissectionLymphadenectomyRandomized controlled trialRight colon cancerRight hemicolectomy

Identifiers

PMID38087139
PMCPMC10838239
OpenAlexW4389609193

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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.