Nickel, Felix, Studier-Fischer, Alexander, Hausmann, David ORCID: 0000-0002-0571-4710, Klotz, Rosa, Vogel-Adigozalov, Sophia Lara, Tenckhoff, Solveig, Klose, Christina, Feisst, Manuel, Zimmermann, Samuel, Babic, Benjamin ORCID: 0000-0003-0313-6862, Berlt, Felix, Bruns, Christiane, Gockel, Ines, Graf, Sandra, Grimminger, Peter, Gutschow, Christian A., Hoeppner, Jens, Ludwig, Kaja, Mirow, Lutz, Moenig, Stefan, Reim, Daniel, Seyfried, Florian, Stange, Daniel, Billeter, Adrian, Nienhueser, Henrik, Probst, Pascal, Schmidt, Thomas and Mueller-Stich, Beat Peter (2022). Minimally invasivE versus open total GAstrectomy (MEGA): study protocol for a multicentre randomised controlled trial (DRKS00025765). BMJ Open, 12 (10). LONDON: BMJ PUBLISHING GROUP. ISSN 2044-6055

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Abstract

Introduction The only curative treatment for most gastric cancer is radical gastrectomy with D2 lymphadenectomy (LAD). Minimally invasive total gastrectomy (MIG) aims to reduce postoperative morbidity, but its use has not yet been widely established in Western countries. Minimally invasivE versus open total GAstrectomy is the first Western multicentre randomised controlled trial (RCT) to compare postoperative morbidity following MIG vs open total gastrectomy (OG). Methods and analysis This superiority multicentre RCT compares MIG (intervention) to OG (control) for oncological total gastrectomy with D2 or D2+LAD. Recruitment is expected to last for 2 years. Inclusion criteria comprise age between 18 and 84 years and planned total gastrectomy after initial diagnosis of gastric carcinoma. Exclusion criteria include Eastern Co-operative Oncology Group (ECOG) performance status >2, tumours requiring extended gastrectomy or less than total gastrectomy, previous abdominal surgery or extensive adhesions seriously complicating MIG, other active oncological disease, advanced stages (T4 or M1), emergency setting and pregnancy. The sample size was calculated at 80 participants per group. The primary endpoint is 30-day postoperative morbidity as measured by the Comprehensive Complications Index. Secondary endpoints include postoperative morbidity and mortality, adherence to a fast-track protocol and patient-reported quality of life (QoL) scores (QoR-15, EUROQOL EuroQol-5 Dimensions-5 Levels (EQ-5D), EORTC QLQ-C30, EORTC QLQ-STO22, activities of daily living and Body Image Scale). Oncological endpoints include rate of R0 resection, lymph node yield, disease-free survival and overall survival at 60-month follow-up. Ethics and dissemination Ethical approval has been received by the independent Ethics Committee of the Medical Faculty, University of Heidelberg (S-816/2021) and will be received from each responsible ethics committee for each individual participating centre prior to recruitment. Results will be published open access.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Nickel, FelixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Studier-Fischer, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hausmann, DavidUNSPECIFIEDorcid.org/0000-0002-0571-4710UNSPECIFIED
Klotz, RosaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vogel-Adigozalov, Sophia LaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tenckhoff, SolveigUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klose, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Feisst, ManuelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zimmermann, SamuelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Babic, BenjaminUNSPECIFIEDorcid.org/0000-0003-0313-6862UNSPECIFIED
Berlt, FelixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bruns, ChristianeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gockel, InesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Graf, SandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grimminger, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gutschow, Christian A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoeppner, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ludwig, KajaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mirow, LutzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moenig, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reim, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seyfried, FlorianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stange, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Billeter, AdrianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nienhueser, HenrikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Probst, PascalUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller-Stich, Beat PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-694157
DOI: 10.1136/bmjopen-2022-064286
Journal or Publication Title: BMJ Open
Volume: 12
Number: 10
Date: 2022
Publisher: BMJ PUBLISHING GROUP
Place of Publication: LONDON
ISSN: 2044-6055
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ASSISTED DISTAL GASTRECTOMY; EARLY GASTRIC-CANCER; ADJUSTED LIFE-YEARS; LONG-TERM OUTCOMES; POSTOPERATIVE COMPLICATIONS; CURATIVE RESECTION; COMPARING OPEN; RADICAL GASTRECTOMY; SYSTEMATIC ANALYSIS; GLOBAL BURDENMultiple languages
Medicine, General & InternalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69415

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