Open AccessProspective, observational, multicenter study on minimally invasive gastrectomy for gastric cancer: robotic, laparoscopic and open surgery compared on operative and follow-up outcomes - IMIGASTRIC II study protocol: IMIGASTRIC II
Author(s) -
Jacopo Desiderio,
Lin Ji,
Enrique Norero,
Felice Borghi,
Alessandra Marano,
Fabio Cianchi,
Benedetta Badii,
Feng Qi,
Tong Liu,
Daniel Reim,
Alexander Novotny,
Andrea Coratti,
Francesco Guerra,
Ninh T. Nguyen,
Orhan Ali̇moğlu,
İbrahim Ali Özemir,
Steven T. Brower,
Francesca Bazzocchi,
Andrea Avanzolini,
Leonardo Solaini,
Orestis Ioannidis,
Christos Chatzakis,
Lydia Loutzidou,
Arda Işık,
Maurizio Cesari,
Graziano Pernazza,
J. S. Azagra,
Martine Goergen,
Yanbing Zhou,
Shougen Cao,
Johan Gagnière,
Denis Pezet,
S D’Imporzano,
Olivier SaintMarc,
Rémy Sindayigaya,
Lu Zang,
Natalie Coburn,
Cüneyt Kayaalp,
Giacomo Arcuri,
Francesco Giovanardi,
Stefano Trastulli,
Amilcare Parisi,
Chao-Hui Zheng,
ChangMing Huang
Publication year - 2019
Publication title -
journal of gastric surgery
Language(s) - English
Resource type - Journals
eISSN - 2704-9108
pISSN - 2704-8284
DOI - 10.36159/jgs.v1i1.13
Subject(s) - medicine , observational study , invasive surgery , protocol (science) , prospective cohort study , clinical trial , general surgery , cancer , institutional review board , surgery , laparoscopy , helsinki declaration , gastrectomy , informed consent , alternative medicine , pathology
Background: Several meta-analyses have tried to defi ne the role of minimally invasive approaches. However, further evidence to get a wider spread of these methods is necessary. Current studies describe minimally invasive surgery as a possible alternative to open surgery but deserving further clarifi cation. However, despite the increasing interest, the difficulty of planning prospective studies of adequate size accounts for the low level of evidence, which is mostly based on retrospective experiences. A multi-institutional prospective study allows the collection of an impressive amount of data to investigate various aspects of minimally invasive procedures with the opportunity of developing several subgroup analyses. A prospective data collection with high methodological quality on minimally invasive and open gastrectomies can clarify the role of diff erent procedures with the aim to develop specifi c guidelines. Methods and analysis: a multi-institutional prospective database will be established including information on surgical, clinical and oncological features of patients treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up. The study has been shared by the members of the International study group on Minimally Invasive surgery for GASTRIc Cancer (IMIGASTRIC) The database is designed to be an international electronic submission system and a HIPPA protected real time data repository from high volume gastric cancer centers. Ethics: This study is conducted in compliance with ethical principles originating from the Helsinki Declaration, within the guidelines of Good Clinical Practice and relevant laws/regulations. Trial registration number: NCT02751086