Evidence map›Paper›PMID 33608405›Full record

Trial reportBMJ open2021

Prospective, randomised, multicentre, open-label trial, designed to evaluate the best timing of closure of the temporary ileostomy (early versus late) in patients who underwent rectal cancer resection and with indication for adjuvant chemotherapy: the STOMAD (STOMa closure before or after ADjuvant therapy) randomised controlled trial.

Paolo Massucco, Andrea Fontana, Michela Mineccia, Serena Perotti, Giovannino Ciccone, Claudia Galassi, Maria Carmela Giuffrida, Donatella Marino, Igor Monsellato, Myriam Katja Paris and 31 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04372992 (Multicenter Randomized Controlled Phase III Trial Comparing Ileostomy Closure Before or After Adjuvant Therapy in Patients Operated for Rectal Cancer), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.8field-weighted citation impact, top 25% 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.

NCT04372992 naterminatednot on this map

Multicenter Randomized Controlled Phase III Trial Comparing Ileostomy Closure Before or After Adjuvant Therapy in Patients Operated for Rectal Cancer

TypeinterventionalSponsorOspedale Umberto I di TorinoRan2020 to 2022Enrolled14ConditionsIleostomy, Rectal CancerArmsTiming of stoma closure
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Early Closure of Diverting Ileostomy After Rectal Resection: Are We Ready to Make the Shift?Acta informatica medica : AIM : journal of the Society for Medical Informatics of Bosnia & Herzegovina : casopis Drustva za medicinsku informatiku BiH · 2025
    Review
  11. Article
  12. 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

41 authors at 20 institutions in 3 countries.

Paolo MassuccoDepartment of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy pmassucco@mauriziano.it.ORCID 0000-0003-1620-0464
Andrea FontanaDepartment of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.
Michela MinecciaDepartment of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.
Serena PerottiDepartment of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.
Giovannino CicconeClinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.
Claudia GalassiClinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.
Maria Carmela GiuffridaDepartment of Surgery, Azienda Ospedaliera S Croce e Carle, Cuneo, Italy.
Donatella MarinoDepartment of Oncology, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.
Igor MonsellatoDepartment of Surgery, Azienda Ospedaliera Nazionale SS Antonio e Biagio e C Arrigo, Alessandria, Italy.
Myriam Katja ParisDepartment of Oncology, Ospedale degli Infermi, Ponderano (BI), Italy.
Roberto PerinottiDepartment of Surgery, Ospedale degli Infermi, Ponderano (BI), Italy.
Patrizia RaccaColorectal Cancer Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.
Chiara MonaghedduClinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.
Fabio SacconaClinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.
Elisa PonteDepartment of Surgery, Ospedale Regionale Umberto Parini, Aosta, Italy.
Massimiliano MistrangeloDepartment of Surgical Science, Turin University, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.ORCID 0000-0001-8506-6794
Mauro SantarelliDepartment of General and Emergency Surgery, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.
Francesco TomaselliDepartment of Surgery, Ospedale Martini, Torino, Italy.
Rossella ReddavidDepartment of Surgical Oncology and Digestive Surgery, Turin University, Azienda Ospedaliero Universitaria San Luigi Gonzaga, Orbassano (TO), Italy.
Simone BiroloDepartment of Surgery, Ospedale degli Infermi, Rivoli (TO), Italy.
Marcello CalabròDepartment of Surgery, Ospedale Edoardo Agnelli, Pinerolo (TO), Italy.
Nicoletta PipitoneDepartment of Surgery, Ospedale Edoardo Agnelli, Pinerolo (TO), Italy.
Luca Panier SuffatDepartment of Surgery, Ospedale di Ivrea, Ivrea (TO), Italy.
Monica CarreraDepartment of Surgery, Ospedale di Ciriè, Ciriè (TO), Italy.
Francesco PotenteDepartment of Surgery, Ospedale Santa Croce, Moncalieri (TO), Italy.
Marco BrunettiDepartment of Surgery, Ospedale SS Annunziata, Savigliano (CN), Italy.
Roberto RimondaDepartment of Surgery, Ospedale Regina Montis, Mondovì (CN), Italy.
Vincenzo AdamoDepartment of Surgery, Ospedale San Lazzaro, Alba (CN), Italy.
Domenico PiscioneriDepartment of Surgery, Azienda Ospedaliera Nazionale SS Antonio e Biagio e C Arrigo, Alessandria, Italy.
Francesca CraveroDepartment of Surgery, Ospedale Santo Spirito, Casale Monferrato (AL), Italy.
Alberto ServentiDepartment of Surgery, Ospedale Mons. Galliano, Acqui Terme (AL), Italy.
Eliana GiaminardiDepartment of Surgery, Ospedale San Giacomo, Novi Ligure (AL), Italy.
Luca MazzaDepartment of Surgery, Ospedale Cardinal Massaia, Asti, Italy.
Paolo BelloraDepartment of Surgery, Eastern Piedmont University, Azienda Ospedaliera Maggiore della Carita, Novara, Italy.
Fabio ColliDepartment of Surgery, Azienda Ospedaliera Maggiore della Carità, Novara, Italy.
Clemente De RosaDepartment of Surgery, Presidio Ospedaliero Sant'Andrea, Vercelli, Italy.
Francesco BattafaranoDepartment of Surgery, Ospedale S. Biagio, Domodossola (VB), Italy.
Renza TrapaniDepartment of Surgery, Ospedale Castelli, Verbania (VB), Italy.
Alfredo MellanoColorectal Surgical Unit, IRCCS, Candiolo (TO), Italy.
Enrico GibinDepartment of Surgery, Presidio Sanitario Ospedale Cottolengo, Torino, Italy.
Paola BellomoDepartment of Surgery, Humanitas Gradenigo, Torino, Italy.
Azienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITA. O. Ordine Mauriziano di Torino · ITOspedale degli Infermi · ITAzienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo · ITOspedale Civile Di Ivrea · ITOspedale Civile Edoardo Agnelli · ITPresidio Ospedaliero · ITUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITAzienda Sanitaria Locale CN2 · ITAzienda Sanitaria Locale di Asti · ITAzienda Sanitaria Ospedaliera S.Croce e Carle Cuneo · ITColorectal Surgical Associates · USHumanitas Castelli · ITOspedale degli Infermi · ITOspedale di Santo Spirito · ITOspedale Humanitas Gradenigo · ITOspedale Martini · ITOspedale Regina Margherita · ITOspedale San Giacomo Apostolo · ITOspedale San Luigi Gonzaga · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTemporary ileostomy is a valuable aid in reducing the severity of complications related to rectal cancer surgery. However, it is still unclear what is the best timing of its closure in relation to the feasibility of an adjuvant treatment, especially considering patient-reported outcomes and health system costs. The aim of the study is to compare the results of an early versus late closure strategy in patients with indication to adjuvant chemotherapy after resection for rectal cancer. METHODS AND ANALYSIS: This is a prospective multicentre randomised trial, sponsored by Rete Oncologica Piemonte e Valle d'Aosta (Oncology Network of Piedmont and Aosta Valley-Italy). Patients undergone to rectal cancer surgery with temporary ileostomy, aged >18 years, without evidence of anastomotic leak and with indication to adjuvant chemotherapy will be enrolled in 28 Network centres. An early closure strategy (between 30 and 40 days from rectal surgery) will be compared with a late one (after the end of adjuvant therapy). Primary endpoint will be the compliance to adjuvant chemotherapy with and without ileostomy. Complications associated with stoma closure as well as quality of life, costs and oncological outcomes will be assessed as secondary endpoints. ETHICS AND DISSEMINATION: The trial will engage the Network professional teams in a common effort to improve the treatment of rectal cancer by ensuring the best results in relation to the most correct use of resources. It will take into consideration both the patients' point of view (patient-reported outcome) and the health system perspective (costs analysis). The study has been approved by the Ethical Review Board of Città della Salute e della Scienza Hospital in Turin (Italy). The results of the study will be disseminated by the Network website, medical conferences and peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT04372992.

Indexed as

IleostomyRectal NeoplasmsAgedChemotherapy, AdjuvantHumansItalyPostoperative ComplicationsProspective StudiesQuality of LifeTime Factorschemotherapycolorectal surgeryquality in health care

Identifiers

PMID33608405
PMCPMC7896613
OpenAlexW3131995366

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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.