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
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...
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| creator | Massucco, Paolo Fontana, Andrea Mineccia, Michela Perotti, Serena Ciccone, Giovannino Galassi, Claudia Giuffrida, Maria Carmela Marino, Donatella Monsellato, Igor Paris, Myriam Katja Perinotti, Roberto Racca, Patrizia Monagheddu, Chiara Saccona, Fabio Ponte, Elisa Mistrangelo, Massimiliano Santarelli, Mauro Tomaselli, Francesco Reddavid, Rossella Birolo, Simone Calabrò, Marcello Pipitone, Nicoletta Panier Suffat, Luca Carrera, Monica Potente, Francesco Brunetti, Marco Rimonda, Roberto Adamo, Vincenzo Piscioneri, Domenico Cravero, Francesca Serventi, Alberto Giaminardi, Eliana Mazza, Luca Bellora, Paolo Colli, Fabio De Rosa, Clemente Battafarano, Francesco Trapani, Renza Mellano, Alfredo Gibin, Enrico Bellomo, Paola |
| description | 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 analysisThis 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 disseminationThe 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 numberNCT04372992. |
| doi_str_mv | 10.1136/bmjopen-2020-044692 |
| format | Article |
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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 analysisThis 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 disseminationThe 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 numberNCT04372992.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2020-044692</identifier><identifier>PMID: 33608405</identifier><language>eng</language><publisher>LONDON: Bmj Publishing Group</publisher><subject>Adjuvants ; Aged ; Cancer therapies ; Chemotherapy ; Chemotherapy, Adjuvant ; Colorectal cancer ; Endoscopy ; Fistula ; General & Internal Medicine ; Hospitals ; Humans ; Ileostomy ; Italy ; Licensed products ; Life Sciences & Biomedicine ; Medicine, General & Internal ; Ostomy ; Patients ; Postoperative Complications ; Prospective Studies ; Quality of Life ; Rectal Neoplasms - drug therapy ; Rectal Neoplasms - surgery ; Science & Technology ; Surgery ; Time Factors</subject><ispartof>BMJ open, 2021-02, Vol.11 (2), p.e044692-e044692, Article 044692</ispartof><rights>Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2021 Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>6</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000621252500019</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-b538t-18069416a858444a760e96b33d31ce9f82ac5efd4adaa9991ef6a1849b4026803</citedby><cites>FETCH-LOGICAL-b538t-18069416a858444a760e96b33d31ce9f82ac5efd4adaa9991ef6a1849b4026803</cites><orcidid>0000-0001-8506-6794 ; 0000-0003-1620-0464 ; 0000-0003-3096-7901 ; 0000-0002-4980-374X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/11/2/e044692.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/11/2/e044692.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,315,729,782,786,866,887,2106,2118,27558,27559,27933,27934,39267,53800,53802,77611,77642</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33608405$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Massucco, Paolo</creatorcontrib><creatorcontrib>Fontana, Andrea</creatorcontrib><creatorcontrib>Mineccia, Michela</creatorcontrib><creatorcontrib>Perotti, Serena</creatorcontrib><creatorcontrib>Ciccone, Giovannino</creatorcontrib><creatorcontrib>Galassi, Claudia</creatorcontrib><creatorcontrib>Giuffrida, Maria Carmela</creatorcontrib><creatorcontrib>Marino, Donatella</creatorcontrib><creatorcontrib>Monsellato, Igor</creatorcontrib><creatorcontrib>Paris, Myriam Katja</creatorcontrib><creatorcontrib>Perinotti, Roberto</creatorcontrib><creatorcontrib>Racca, Patrizia</creatorcontrib><creatorcontrib>Monagheddu, Chiara</creatorcontrib><creatorcontrib>Saccona, Fabio</creatorcontrib><creatorcontrib>Ponte, Elisa</creatorcontrib><creatorcontrib>Mistrangelo, Massimiliano</creatorcontrib><creatorcontrib>Santarelli, Mauro</creatorcontrib><creatorcontrib>Tomaselli, Francesco</creatorcontrib><creatorcontrib>Reddavid, Rossella</creatorcontrib><creatorcontrib>Birolo, Simone</creatorcontrib><creatorcontrib>Calabrò, Marcello</creatorcontrib><creatorcontrib>Pipitone, Nicoletta</creatorcontrib><creatorcontrib>Panier Suffat, Luca</creatorcontrib><creatorcontrib>Carrera, Monica</creatorcontrib><creatorcontrib>Potente, Francesco</creatorcontrib><creatorcontrib>Brunetti, Marco</creatorcontrib><creatorcontrib>Rimonda, Roberto</creatorcontrib><creatorcontrib>Adamo, Vincenzo</creatorcontrib><creatorcontrib>Piscioneri, Domenico</creatorcontrib><creatorcontrib>Cravero, Francesca</creatorcontrib><creatorcontrib>Serventi, Alberto</creatorcontrib><creatorcontrib>Giaminardi, Eliana</creatorcontrib><creatorcontrib>Mazza, Luca</creatorcontrib><creatorcontrib>Bellora, Paolo</creatorcontrib><creatorcontrib>Colli, Fabio</creatorcontrib><creatorcontrib>De Rosa, Clemente</creatorcontrib><creatorcontrib>Battafarano, Francesco</creatorcontrib><creatorcontrib>Trapani, Renza</creatorcontrib><creatorcontrib>Mellano, Alfredo</creatorcontrib><creatorcontrib>Gibin, Enrico</creatorcontrib><creatorcontrib>Bellomo, Paola</creatorcontrib><title>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</title><title>BMJ open</title><addtitle>BMJ OPEN</addtitle><addtitle>BMJ Open</addtitle><description>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 analysisThis 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 disseminationThe 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 numberNCT04372992.</description><subject>Adjuvants</subject><subject>Aged</subject><subject>Cancer therapies</subject><subject>Chemotherapy</subject><subject>Chemotherapy, Adjuvant</subject><subject>Colorectal cancer</subject><subject>Endoscopy</subject><subject>Fistula</subject><subject>General & Internal Medicine</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Ileostomy</subject><subject>Italy</subject><subject>Licensed products</subject><subject>Life Sciences & Biomedicine</subject><subject>Medicine, General & Internal</subject><subject>Ostomy</subject><subject>Patients</subject><subject>Postoperative Complications</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Rectal Neoplasms - drug therapy</subject><subject>Rectal Neoplasms - surgery</subject><subject>Science & Technology</subject><subject>Surgery</subject><subject>Time 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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</title><author>Massucco, Paolo ; Fontana, Andrea ; Mineccia, Michela ; Perotti, Serena ; Ciccone, Giovannino ; Galassi, Claudia ; Giuffrida, Maria Carmela ; Marino, Donatella ; Monsellato, Igor ; Paris, Myriam Katja ; Perinotti, Roberto ; Racca, Patrizia ; Monagheddu, Chiara ; Saccona, Fabio ; Ponte, Elisa ; Mistrangelo, Massimiliano ; Santarelli, Mauro ; Tomaselli, Francesco ; Reddavid, Rossella ; Birolo, Simone ; Calabrò, Marcello ; Pipitone, Nicoletta ; Panier Suffat, Luca ; Carrera, Monica ; Potente, Francesco ; Brunetti, Marco ; Rimonda, Roberto ; Adamo, Vincenzo ; Piscioneri, Domenico ; Cravero, Francesca ; Serventi, Alberto ; Giaminardi, Eliana ; Mazza, Luca ; Bellora, Paolo ; Colli, Fabio ; De Rosa, Clemente ; Battafarano, Francesco ; Trapani, Renza ; Mellano, Alfredo ; Gibin, Enrico ; Bellomo, Paola</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b538t-18069416a858444a760e96b33d31ce9f82ac5efd4adaa9991ef6a1849b4026803</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adjuvants</topic><topic>Aged</topic><topic>Cancer therapies</topic><topic>Chemotherapy</topic><topic>Chemotherapy, Adjuvant</topic><topic>Colorectal cancer</topic><topic>Endoscopy</topic><topic>Fistula</topic><topic>General & Internal Medicine</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Ileostomy</topic><topic>Italy</topic><topic>Licensed products</topic><topic>Life Sciences & Biomedicine</topic><topic>Medicine, General & Internal</topic><topic>Ostomy</topic><topic>Patients</topic><topic>Postoperative Complications</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Rectal Neoplasms - drug therapy</topic><topic>Rectal Neoplasms - surgery</topic><topic>Science & Technology</topic><topic>Surgery</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Massucco, Paolo</creatorcontrib><creatorcontrib>Fontana, Andrea</creatorcontrib><creatorcontrib>Mineccia, Michela</creatorcontrib><creatorcontrib>Perotti, Serena</creatorcontrib><creatorcontrib>Ciccone, Giovannino</creatorcontrib><creatorcontrib>Galassi, Claudia</creatorcontrib><creatorcontrib>Giuffrida, Maria Carmela</creatorcontrib><creatorcontrib>Marino, Donatella</creatorcontrib><creatorcontrib>Monsellato, Igor</creatorcontrib><creatorcontrib>Paris, Myriam Katja</creatorcontrib><creatorcontrib>Perinotti, Roberto</creatorcontrib><creatorcontrib>Racca, Patrizia</creatorcontrib><creatorcontrib>Monagheddu, Chiara</creatorcontrib><creatorcontrib>Saccona, Fabio</creatorcontrib><creatorcontrib>Ponte, Elisa</creatorcontrib><creatorcontrib>Mistrangelo, Massimiliano</creatorcontrib><creatorcontrib>Santarelli, Mauro</creatorcontrib><creatorcontrib>Tomaselli, Francesco</creatorcontrib><creatorcontrib>Reddavid, Rossella</creatorcontrib><creatorcontrib>Birolo, Simone</creatorcontrib><creatorcontrib>Calabrò, Marcello</creatorcontrib><creatorcontrib>Pipitone, Nicoletta</creatorcontrib><creatorcontrib>Panier Suffat, Luca</creatorcontrib><creatorcontrib>Carrera, Monica</creatorcontrib><creatorcontrib>Potente, Francesco</creatorcontrib><creatorcontrib>Brunetti, Marco</creatorcontrib><creatorcontrib>Rimonda, Roberto</creatorcontrib><creatorcontrib>Adamo, Vincenzo</creatorcontrib><creatorcontrib>Piscioneri, Domenico</creatorcontrib><creatorcontrib>Cravero, Francesca</creatorcontrib><creatorcontrib>Serventi, Alberto</creatorcontrib><creatorcontrib>Giaminardi, Eliana</creatorcontrib><creatorcontrib>Mazza, Luca</creatorcontrib><creatorcontrib>Bellora, Paolo</creatorcontrib><creatorcontrib>Colli, Fabio</creatorcontrib><creatorcontrib>De Rosa, Clemente</creatorcontrib><creatorcontrib>Battafarano, Francesco</creatorcontrib><creatorcontrib>Trapani, Renza</creatorcontrib><creatorcontrib>Mellano, Alfredo</creatorcontrib><creatorcontrib>Gibin, Enrico</creatorcontrib><creatorcontrib>Bellomo, Paola</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Web of Science - Science Citation Index Expanded - 2021</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Massucco, Paolo</au><au>Fontana, Andrea</au><au>Mineccia, Michela</au><au>Perotti, Serena</au><au>Ciccone, Giovannino</au><au>Galassi, Claudia</au><au>Giuffrida, Maria Carmela</au><au>Marino, Donatella</au><au>Monsellato, Igor</au><au>Paris, Myriam Katja</au><au>Perinotti, Roberto</au><au>Racca, Patrizia</au><au>Monagheddu, Chiara</au><au>Saccona, Fabio</au><au>Ponte, Elisa</au><au>Mistrangelo, Massimiliano</au><au>Santarelli, Mauro</au><au>Tomaselli, Francesco</au><au>Reddavid, Rossella</au><au>Birolo, Simone</au><au>Calabrò, Marcello</au><au>Pipitone, Nicoletta</au><au>Panier Suffat, Luca</au><au>Carrera, Monica</au><au>Potente, Francesco</au><au>Brunetti, Marco</au><au>Rimonda, Roberto</au><au>Adamo, Vincenzo</au><au>Piscioneri, Domenico</au><au>Cravero, Francesca</au><au>Serventi, Alberto</au><au>Giaminardi, Eliana</au><au>Mazza, Luca</au><au>Bellora, Paolo</au><au>Colli, Fabio</au><au>De Rosa, Clemente</au><au>Battafarano, Francesco</au><au>Trapani, Renza</au><au>Mellano, Alfredo</au><au>Gibin, Enrico</au><au>Bellomo, Paola</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>BMJ open</jtitle><stitle>BMJ OPEN</stitle><addtitle>BMJ Open</addtitle><date>2021-02-19</date><risdate>2021</risdate><volume>11</volume><issue>2</issue><spage>e044692</spage><epage>e044692</epage><pages>e044692-e044692</pages><artnum>044692</artnum><issn>2044-6055</issn><eissn>2044-6055</eissn><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 analysisThis 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 disseminationThe 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 numberNCT04372992.</abstract><cop>LONDON</cop><pub>Bmj Publishing Group</pub><pmid>33608405</pmid><doi>10.1136/bmjopen-2020-044692</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-8506-6794</orcidid><orcidid>https://orcid.org/0000-0003-1620-0464</orcidid><orcidid>https://orcid.org/0000-0003-3096-7901</orcidid><orcidid>https://orcid.org/0000-0002-4980-374X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2044-6055 |
| ispartof | BMJ open, 2021-02, Vol.11 (2), p.e044692-e044692, Article 044692 |
| issn | 2044-6055 2044-6055 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7896613 |
| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central Open Access; Web of Science - Science Citation Index Expanded - 2021<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" />; PubMed Central |
| subjects | Adjuvants Aged Cancer therapies Chemotherapy Chemotherapy, Adjuvant Colorectal cancer Endoscopy Fistula General & Internal Medicine Hospitals Humans Ileostomy Italy Licensed products Life Sciences & Biomedicine Medicine, General & Internal Ostomy Patients Postoperative Complications Prospective Studies Quality of Life Rectal Neoplasms - drug therapy Rectal Neoplasms - surgery Science & Technology Surgery Time Factors |
| title | 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 |
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