Standardizing Right Hemicolectomy for Colon Cancer

NCT04889456 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 930

Last updated 2021-05-17

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04889456 on ClinicalTrials.gov