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dc.contributor.authorKaido, Toshimien
dc.contributor.authorShimamura, Tsuyoshien
dc.contributor.authorSugawara, Yasuhikoen
dc.contributor.authorSadamori, Hiroshien
dc.contributor.authorShirabe, Kenen
dc.contributor.authorYamamoto, Michioen
dc.contributor.authorUemoto, Shinjien
dc.contributor.alternative海道, 利実ja
dc.contributor.alternative上本, 伸二ja
dc.date.accessioned2016-07-22T05:57:43Z-
dc.date.available2016-07-22T05:57:43Z-
dc.date.issued2015-09-29-
dc.identifier.issn2044-6055-
dc.identifier.urihttp://hdl.handle.net/2433/216062-
dc.description.abstractIntroduction: This multicentre randomised controlled clinical trial will aim to determine the ability of an extract (TJ-100) of Daikenchuto (traditional Japanese herbal medicine; Kampo) to prevent bowel dysfunction in at least 110 patients after liver transplantation (LT). Methods and analysis: The following co-primary end points will be evaluated on postoperative day 7: total oral and enteral caloric intake, abdominal distension and abdominal pain. The secondary end points will comprise sequential changes of total oral and enteral caloric intake after LT, sequential changes in numeric rating scales for abdominal distension and pain, elapsed time to the first postoperative passage of stool, quality of life assessment using the Gastrointestinal Symptom Rating Scale score (Japanese version), postoperative liver function, liver regeneration rate, incidence of bacteraemia and bacterial strain, trough level of immunosuppressants, occurrence of acute cellular rejection, discharge or not within 2 months after LT, sequential changes of portal venous flow to the graft and ascites discharge. The two arms of the study will comprise 55 patients per arm. Ethics and dissemination: The study has been conducted according to the CONSORT statement. All participants signed a written consent form, and the study has been approved by the institutional review board of each participating institute and conducted in accordance with the Declaration of Helsinki of 1996. The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals.en
dc.format.mimetypeapplication/pdf-
dc.language.isoeng-
dc.publisherBMJ Publishing Groupen
dc.rightsThis 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 and the use is non-commercial.en
dc.titleMulticentre, randomised, placebocontrolled trial of extract of Japanese herbal medicine Daikenchuto to prevent bowel dysfunction after adult liver transplantation (DKB 14 Study)en
dc.typejournal article-
dc.type.niitypeJournal Article-
dc.identifier.jtitleBMJ Openen
dc.identifier.volume5-
dc.relation.doi10.1136/bmjopen-2015-008356-
dc.textversionpublisher-
dc.identifier.artnume008356-
dc.identifier.pmid26419681-
dcterms.accessRightsopen access-
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