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Minimally invasive right colectomy anastomosis study (MIRCAST) : protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor |
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| Author: | Gomez Ruiz, Marcos1,2; Pietro Bianchi, Paolo3; Chaudhri, Sanjay4; |
| Organizations: |
1Unidad de Cirugía Colorrectal, Servicio de Cirugía General y Aparato Digestivo, Hospital Universitario Marqués de Valdecilla, Av. Valdecilla s/n, 39008, Santander, Spain 2IDIVAL, Instituto de Investigación Sanitaria, 39008, Santander, Spain 3Department of Surgery, Division of General and Minimally-Invasive Surgery, International School of Robotic Surgery, Clinical Robotic Surgery Association (CRSA), Ospedale La Misericordia, Via Senese 170, 58100, Grosseto, Italy
4Leicester General Hospital, University Hospitals Leicester NHS Trust, Leicester, UK
5Department of Surgery, Danderyd University Hospital, 182 88, Stockholm, Sweden 6Department Surgery, Center for Surgical Science, Zealand University Hospital, Institute for Clinical Medicine, Copenhagen University, Copenhagen, Denmark 7Surgery, Level 7 Clinical Sciences Building St James’s University Hospital, Leeds, LS9 7TF, UK 8Portsmouth Hospitals NHS Trust, University of Portsmouth, Portsmouth, UK 9Anglia Ruskin University, Chelmsford, England 10Department of Surgery, Oulu University Hospital, PL 21 OYS, 90029, Oulu, Finland 11Department of Surgery, General University Hospital Elche, University Miguel Hernández, Camí de l’Almazara 11, CP 03203, Elche, Spain 12Digestive Surgery and Robotic Surgeyi and Educational, IEO (European Institute of Oncology)-IRCCS-Milan, Milan, Italy 13Department of Surgery, Rheinlandklinikum Lukaskrankenhaus Neuss, 84 41464, Neuss, Germany 14Oncologic surgery, Montpellier Cancer Institute, 34298, Montpellier, France |
| Format: | article |
| Version: | published version |
| Access: | open |
| Online Access: | PDF Full Text (PDF, 1.2 MB) |
| Persistent link: | http://urn.fi/urn:nbn:fi-fe2020102787890 |
| Language: | English |
| Published: |
Springer Nature,
2020
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| Publish Date: | 2020-10-27 |
| Description: |
AbstractBackground: Right colectomy is the standard surgical treatment for tumors in the right colon and surgical complications are reduced with minimally-invasive laparoscopy compared with open surgery, with potential further benefits achieved with robotic assistance. The anastomotic technique used can also have an impact on patient outcomes. However, there are no large, prospective studies that have compared all techniques. Methods/design: MIRCAST is the Minimally-Invasive Right Colectomy Anastomosis Study that will compare laparoscopy with robot-assisted surgery, using either intracorporeal or extracorporeal anastomosis, in a large prospective, observational, multicenter, parallel, four-cohort study in patients with a benign or malignant, non-metastatic tumor of the right colon. Over 2 years of follow-up, the study will prospectively evaluate peri- and postoperative complications, postoperative recovery, hospital stay, and mid-term results including survival, local recurrence, metastases rate, and conversion rate. The primary composite endpoint will be the efficacy of the surgical method regarding surgical wound infections and postoperative complications (Clavien-Dindo grade III-IV complications at 30 days post-surgery). Secondary endpoints include long-term oncologic results, conversion rate, operative time, length of stay, and quality of life. Discussion: This will be the first large, international study to prospectively evaluate the use of minimally-invasive laparoscopy or robot-assisted surgery during right hemicolectomy and to control for the impact of the anastomotic technique. The research will contribute to current knowledge regarding the medical care of patients with malignant or benign tumors of the right colon, and enable physicians to determine which technique may be the most appropriate for their patients. Trial registration: This study was registered on Clinicaltrials.gov (clinicaltrials.gov identifier: NCT03650517) on August 28th 2018 (study protocol version CI18/02 revision A, 21 February 2018). see all
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| Series: |
BMC surgery |
| ISSN: | 1471-2482 |
| ISSN-E: | 1471-2482 |
| ISSN-L: | 1471-2482 |
| Volume: | 20 |
| Issue: | 1 |
| Article number: | 151 |
| DOI: | 10.1186/s12893-020-00803-x |
| OADOI: | https://oadoi.org/10.1186/s12893-020-00803-x |
| Type of Publication: |
A1 Journal article – refereed |
| Field of Science: |
3126 Surgery, anesthesiology, intensive care, radiology |
| Subjects: | |
| Funding: |
A Research Grant was provided by Intuitive Surgical Inc. (Sunnyvale, CA, USA). The study sponsor is the Fundación Instituto de Investigación Marqués de Valdecilla (IDIVAL), Avda Cardenal Herrera Oria s/n, 39011 Santander, Spain. The sponsor is a non-for profit organization and will manage the overall project conduct and will be responsible for the study monitoring and reporting. |
| Copyright information: |
© The Author(s). 2020. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
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https://creativecommons.org/licenses/by/4.0/ |