Standardizing Right Hemicolectomy for Colon Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc

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

930 Participants
are divided into 3 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