Standardizing Right Hemicolectomy for Colon Cancer
NCT04889456 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 930
Last updated 2021-05-17
Summary
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.
Conditions
- Colonic Carcinoma
- Laparoscopic Right Hemicolectomy
- Standardisation
- Training
- Delphi Study
- Implementation
- Consolidation
- Assessment
Interventions
- PROCEDURE
-
Implementation standardised laparoscopic right hemicolectomy with proctoring
Implementation standardised laparoscopic right hemicolectomy with proctoring
- PROCEDURE
-
Implementation standardised laparoscopic right hemicolectomy without proctoring
Implementation standardised laparoscopic right hemicolectomy without proctoring
Sponsors & Collaborators
-
Prof. dr. P.J. Tanis, colorectal surgeon
collaborator UNKNOWN -
Dr. B.R. Toorenvliet, colorectal surgeon
collaborator UNKNOWN -
D. Miskovic, St Marks hospital London, UK
collaborator UNKNOWN -
S. Benz, Klinikverbund SuedWest, Böblingen, Germany
collaborator UNKNOWN -
F. Aigner, Krankenhaus der Barmherzigen Bruder, Graz, Austria
collaborator UNKNOWN -
C.A. Bertelsen, Hillerød University Hospital, Copenhagen, Denmark
collaborator UNKNOWN -
Drs. A.A.J. Grüter
collaborator UNKNOWN -
Dr. U.K. Coblijn
collaborator UNKNOWN -
Dr. H.L. van Westreenen
collaborator UNKNOWN -
Dr. C. Sietses
collaborator UNKNOWN -
Prof. dr. E.C.J. Consten
collaborator UNKNOWN -
Dr. A.W.H. van de Ven
collaborator UNKNOWN -
Dr. P. van Duijvendijk
collaborator UNKNOWN -
Dr. S. van Aalten
collaborator UNKNOWN -
Dr. F. den Boer
collaborator UNKNOWN -
Dr. J.W.A. Leijtens
collaborator UNKNOWN -
Dr. C. Hoff
collaborator UNKNOWN -
Dr. O. van Ruler
collaborator UNKNOWN -
Dr. G. D. Slooter
collaborator UNKNOWN -
Prof. dr. J. Lange
collaborator UNKNOWN -
Prof. dr. G.J. Kleinrensink
collaborator UNKNOWN -
Amsterdam UMC, location VUmc
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-01
- Primary Completion
- 2022-07-01
- Completion
- 2027-07-01
Countries
- Netherlands
Study Locations
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