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{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,3,27]],"date-time":"2023-03-27T04:25:52Z","timestamp":1679891152831},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,3,10]],"date-time":"2023-03-10T00:00:00Z","timestamp":1678406400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,3,10]],"date-time":"2023-03-10T00:00:00Z","timestamp":1678406400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002347","name":"Bundesministerium f\u00fcr Bildung und Forschung","doi-asserted-by":"publisher","award":["01KG2028"]},{"DOI":"10.13039\/501100008977","name":"Universit\u00e4t Ulm","doi-asserted-by":"crossref"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n <jats:title>Background<\/jats:title>\n <jats:p>Oesophageal cancer (EC) is the sixth leading cause of cancer death worldwide. Oesophageal resection is the only curative treatment option for EC which is frequently performed via an abdominal and right thoracic approach (Ivor-Lewis operation). This 2-cavity operation is associated with a high risk of major complications. To reduce postoperative morbidity, several minimally invasive techniques have been developed that can be broadly classified into either hybrid oesophagectomy (HYBRID-E) via laparoscopic\/robotic abdominal and open thoracic surgery or total minimally invasive oesophagectomy (MIN-E). Both, HYBIRD-E and MIN-E, compare favourable to open oesophagectomy. However, there is still an evidence gap comparing HYBRID-E with MIN-E with regard to postoperative morbidity.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Methods<\/jats:title>\n <jats:p>The MICkey trial is a multicentre randomized controlled superiority trial with two parallel study groups. A total of 152 patients with oesophageal cancer scheduled for elective oesophagectomy will be randomly assigned 1:1 to the control group (HYBRID-E) or to the intervention group (MIN-E). The primary endpoint will be overall postoperative morbidity assessed via the comprehensive complication index (CCI) within 30 days after surgery. Specific perioperative parameters, as well as patient-reported and oncological outcomes, will be analysed as secondary outcomes.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Discussion<\/jats:title>\n <jats:p>The MICkey trial will address the yet unanswered question whether the total minimally invasive oesophagectomy (MIN-E) is superior to the HYBRID-E procedure regarding overall postoperative morbidity.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Trial registration<\/jats:title>\n <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/drks.de\/search\/de\/trial\/DRKS00027927\">DRKS00027927<\/jats:ext-link> U1111-1277-0214. Registered on 4th July 2022<\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s13063-023-07134-1","type":"journal-article","created":{"date-parts":[[2023,3,26]],"date-time":"2023-03-26T20:19:02Z","timestamp":1679861942000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Overall morbidity after total minimally invasive keyhole oesophagectomy versus hybrid oesophagectomy (the MICkey trial): study protocol for a multicentre randomized controlled trial"],"prefix":"10.1186","volume":"24","author":[{"given":"Rosa","family":"Klotz","sequence":"first","affiliation":[]},{"given":"Markus K.","family":"Diener","sequence":"additional","affiliation":[]},{"given":"Thomas","family":"Schmidt","sequence":"additional","affiliation":[]},{"given":"Thilo","family":"Hackert","sequence":"additional","affiliation":[]},{"given":"Sandra","family":"Graf","sequence":"additional","affiliation":[]},{"given":"Hans F.","family":"Fuchs","sequence":"additional","affiliation":[]},{"given":"Peter","family":"Grimminger","sequence":"additional","affiliation":[]},{"given":"Jan-Hendrick","family":"Egberts","sequence":"additional","affiliation":[]},{"given":"Ines","family":"Gockel","sequence":"additional","affiliation":[]},{"given":"Pieter C.","family":"van der Sluis","sequence":"additional","affiliation":[]},{"given":"Colette","family":"Doerr-Harim","sequence":"additional","affiliation":[]},{"given":"Christina","family":"Klose","sequence":"additional","affiliation":[]},{"given":"Manuel","family":"Fei\u00dft","sequence":"additional","affiliation":[]},{"ORCID":"http:\/\/orcid.org\/0000-0003-1902-657X","authenticated-orcid":false,"given":"Andre L.","family":"Mihaljevic","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2023,3,10]]},"reference":[{"issue":"1","key":"7134_CR1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1097\/SLA.0b013e318296c732","volume":"258","author":"K Slankamenac","year":"2013","unstructured":"Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien P-A. 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To ensure patient\u2019s rights and safety, the responsible investigator will ensure that the trial will be conducted according to the ethical principles laid out in the Declaration of Helsinki. Before participation in the MICkey trial, written informed consent will be obtained from all study participants. This protocol is designed to ensure that the trial will be conducted and analysed in accordance with ICH-GCP E6. The protocol has already been approved by the independent ethics committee (IEC) of the medical faculty of the University of Ulm (157\/22, 05\/23\/22), and secondary approval of the corresponding ethical bodies of all other participating centres has been or will be obtained. The trial protocol has been formulated in accordance with the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) and SPIRIT guidelines.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate\u00a0{24}"}},{"value":"A model consent form is provided on request. No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication\u00a0{32}"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests\u00a0{28}"}}],"article-number":"175"}} |