TY - JOUR
T1 - National implementation of an optimal standardised technique for right-sided colon cancer
T2 - protocol of an interventional sequential cohort study (Right study)
AU - Grüter, Alexander A. J.
AU - Coblijn, Usha K.
AU - Toorenvliet, Boudewijn R.
AU - Tanis, Pieter J.
AU - Tuynman, Jurriaan B.
AU - the Right Collaborators Group
AU - Aselmann, Heiko
AU - Belgers, Eric H. J.
AU - Belt, Eric J. T.
AU - Benz, Stefan
AU - Croner, Roland S.
AU - van Duijvendijk, Peter
AU - Fletcher, Jordan
AU - Hoff, Christiaan
AU - Hompes, Roel
AU - Miskovic, Danilo
AU - Smits, Anke B.
AU - Stearns, Adam T.
AU - Storli, Kristian E.
AU - van de Ven, Anthony W. H.
AU - van Westreenen, Henderik L.
N1 - Funding Information: Right collaborators group: Heiko Aselmann (Klinikum Region Hannover, Germany), Eric H.J. Belgers (Zuyderland Medisch Centrum, The Netherlands), Eric J.T. Belt (Albert Schweitzer Ziekenhuis, The Netherlands), Stefan Benz (Klinikum Sindelfingen-Böblingen, Germany), Roland S. Croner (University Hospital Magdeburg, Germany), Peter van Duijvendijk (Gelre Hospitals, The Netherlands), Jordan Fletcher (St Mark’s Hospital, United Kingdom), Christiaan Hoff (Medisch Centrum Leeuwarden, The Netherlands), Roel Hompes (Amsterdam UMC location University of Amsterdam, Department of Surgery, Meibergdreef 9, Amsterdam, The Netherlands.), Danilo Miskovic (St Mark’s Hospital, United Kingdom), Anke B. Smits (St. Antonius Ziekenhuis, The Netherlands), Adam T. Stearns (Norfolk and Norwich University Hospital, United Kingdom), Kristian E. Storli (Haraldsplass Diakonale Sykehus, Norway), Anthony W.H. van de Ven (Flevoziekenhuis, The Netherlands), Henderik L. van Westreenen (Isala, The Netherlands) Publisher Copyright: © 2023, The Author(s).
PY - 2023/11
Y1 - 2023/11
N2 - Purpose: Minimally invasive right hemicolectomy (MIRH) is the cornerstone of treatment for patients with right-sided colon cancer. This operation has evolved during recent decades, with many innovations and improvements but this has also resulted in high variability of uptake with subsequent substantial variableness. The aim of this ongoing study is to identify current surgical variations, determine the most optimal and standardised MIRH and nationally train and implement that technique to improve short-term clinical and long-term oncological outcomes. Methods: The Right study is a national multicentre prospective interventional sequential cohort study. Firstly, current local practice was evaluated. Subsequently, a standardised surgical technique for right-sided colon cancer was determined using the Delphi consensus method, and this procedure was trained during hands-on courses. The standardised MIRH will be implemented with proctoring (implementation cohort), after which the performance will be monitored (consolidation cohort). Patients who will receive a minimally invasive (extended) right hemicolectomy for cT1-3N0-2M0 colon cancer will be included. The primary outcome is patient safety reflected in the 90-day overall complication rate according to the Clavien–Dindo classification. Secondary outcomes will include intraoperative complications, 90-day mortality rate, number of resected tumour-positive lymph nodes, completeness of mesocolic excision, surgical quality score, locoregional and distant recurrence and 5-year overall survival. A total number of 1095 patients (365 per cohort) will be included. Discussion: The Right study is designed to safely implement the best surgical practice concerning patients with right-sided colon cancer aiming to standardise and improve the surgical quality of MIRH at a national level. Trial registration: ClinicalTrials.gov: NCT04889456, May 2021.
AB - Purpose: Minimally invasive right hemicolectomy (MIRH) is the cornerstone of treatment for patients with right-sided colon cancer. This operation has evolved during recent decades, with many innovations and improvements but this has also resulted in high variability of uptake with subsequent substantial variableness. The aim of this ongoing study is to identify current surgical variations, determine the most optimal and standardised MIRH and nationally train and implement that technique to improve short-term clinical and long-term oncological outcomes. Methods: The Right study is a national multicentre prospective interventional sequential cohort study. Firstly, current local practice was evaluated. Subsequently, a standardised surgical technique for right-sided colon cancer was determined using the Delphi consensus method, and this procedure was trained during hands-on courses. The standardised MIRH will be implemented with proctoring (implementation cohort), after which the performance will be monitored (consolidation cohort). Patients who will receive a minimally invasive (extended) right hemicolectomy for cT1-3N0-2M0 colon cancer will be included. The primary outcome is patient safety reflected in the 90-day overall complication rate according to the Clavien–Dindo classification. Secondary outcomes will include intraoperative complications, 90-day mortality rate, number of resected tumour-positive lymph nodes, completeness of mesocolic excision, surgical quality score, locoregional and distant recurrence and 5-year overall survival. A total number of 1095 patients (365 per cohort) will be included. Discussion: The Right study is designed to safely implement the best surgical practice concerning patients with right-sided colon cancer aiming to standardise and improve the surgical quality of MIRH at a national level. Trial registration: ClinicalTrials.gov: NCT04889456, May 2021.
KW - Laparoscopic
KW - Minimally invasive
KW - National implementation
KW - Right hemicolectomy
KW - Right-sided colon cancer
KW - Robot-assisted
UR - http://www.scopus.com/inward/record.url?scp=85153724029&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s10151-023-02801-6
DO - https://doi.org/10.1007/s10151-023-02801-6
M3 - Article
C2 - 37097330
SN - 1123-6337
VL - 27
SP - 1083
EP - 1090
JO - Techniques in coloproctology
JF - Techniques in coloproctology
IS - 11
ER -