About this trial
A surgical intervention might be highly variable amongst surgeons and centers. This variability has a potential relevance concerning clinical outcomes.
For right-sided colon cancer, the laparoscopic right hemicolectomy (LRHC) knows substantial variation. Especially since the surgical technique has been evolving during the latest decade with the introduction of intracorporeal anastomosis, a dissection technique within the correct embryological planes (complete mesocolic excision) and central vascular ligation of the segmental branches at its origin, resulting in an optimal lymph node dissection.
Given the insights from recent studies showing the association between quality of surgery and relevant clinical outcomes, there is a great need for a formative quality assessment of LRHC. Detailed objective assessment of the LRHC is currently not performed in clinical practice nor in surgical training. Quality assessment of LRHC has great potential to improve surgical training and furthermore, implementation of a standardized technique will ultimately lead to better quality of care for patients suffering from right-sided colon cancer.
The main objective of this study is to improve surgical outcomes for patient with right-sided colon cancer by a prospective sequential interventional cohort study that aims to standardize the surgical technique with subsequent controlled implementation after standardized review of the current practice in a nationwide multicenter setting. The primary endpoint is the 30-day morbidity according to the Clavien-Dindo classification system.
Eligibility criteria
Qualifiers
Planned laparoscopic (extended) right hemicolectomy for colon cancer of the caecum, ascending colon or hepatic flexure;
Age above 18 years;
cTNM stage 1-3 (CT-staged);
No prior midline or transverse laparotomy;
Disqualifiers
cT4b;
Perforated disease;
Acute obstruction;
Emergency operation;
Trial design
Treatments tested in this trial
- Implementation standardised laparoscopic right hemicolectomy with proctoring
- Implementation standardised laparoscopic right hemicolectomy without proctoring
Treatment groups
Sponsors and collaborators
Amsterdam UMC, location VUmc
Lead sponsor
Prof. dr. P.J. Tanis, colorectal surgeon
Collaborator
Dr. B.R. Toorenvliet, colorectal surgeon
Collaborator
D. Miskovic, St Marks hospital London, UK
Collaborator
S. Benz, Klinikverbund SuedWest, Böblingen, Germany
Collaborator
F. Aigner, Krankenhaus der Barmherzigen Bruder, Graz, Austria
Collaborator
C.A. Bertelsen, Hillerød University Hospital, Copenhagen, Denmark
Collaborator
Drs. A.A.J. Grüter
Collaborator
Dr. U.K. Coblijn
Collaborator
Dr. H.L. van Westreenen
Collaborator
Dr. C. Sietses
Collaborator
Prof. dr. E.C.J. Consten
Collaborator
Dr. A.W.H. van de Ven
Collaborator
Dr. P. van Duijvendijk
Collaborator
Dr. S. van Aalten
Collaborator
Dr. F. den Boer
Collaborator
Dr. J.W.A. Leijtens
Collaborator
Dr. C. Hoff
Collaborator
Dr. O. van Ruler
Collaborator
Dr. G. D. Slooter
Collaborator
Prof. dr. J. Lange
Collaborator
Prof. dr. G.J. Kleinrensink
Collaborator