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NCT Number: NCT04889456

Standardizing Right Hemicolectomy for Colon Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

Location contact

Alexander A.J. Grüter, MD

CONTACT

[email protected]

+316 45552015

Boudewijn R. Toorenvliet, MD, PhD

PRINCIPAL_INVESTIGATOR

Jurriaan B. Tuynman, MD, PhD

PRINCIPAL_INVESTIGATOR

Pieter J. Tanis, MD, PhD, Prof

PRINCIPAL_INVESTIGATOR

Usha K. Coblijn, MD, PhD

CONTACT

[email protected]

+316 43469794

About this study

  • Prospective mapping of current practice with surgical variations in laparoscopic right hemicolectomy (total duration of inclusion 3 months) N= 40 centers N = 310 videos
  • METC approval for the use of anonymized videos of a laparoscopic procedure and collection of corresponding clinical outcomes.
  • Approaching hospitals for participation (high volume centers (50+ colon cancers).
  • Prospective inclusion of consecutive patients undergoing laparoscopic right hemicolectomy in the participating hospitals in three months.
  • Development of Standard Laparoscopic Right Hemicolectomy: an (inter)national Delphi study
  • Approaching specialists to participate in the Delphi method (from participating hospitals in step 1).
  • Identification of crucial steps and measures according to literature and expert's opinion (Delphi method).
  • Documentation of steps and the order in which they need to be performed, development of a competency assessment tool (CAT).
  • Skills center training facility

a. Training the participating surgeons in the method of the standardized laparoscopic right hemicolectomy, as consented in the Delphi method.

  • Implementation of the standardized laparoscopic right hemicolectomy with proctoring during another period with prospective inclusion of consecutive patients with collection of surgical videos in all participating hospitals (N=40 centers, total 310 videos)
  • Rating videos.
  • Comparing with pre-implementation performance based on outcome measures reflecting oncological quality of surgery, and 30-day clinical outcomes.
  • Comparing with pre-implementation performance based on the long-term outcomes. (3-year DFS and 5-year OS).
  • Implementing standardised lap right hemicolectomy (after learning curve without proctoring)
  • Consecutive inclusion of patients (n=310)
  • CT imaging
  • Video analysis
  • Competency analysis
  • Variation analysis
  • Clinico pathological data

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • ASA1-3;
  • No immune modulating medication.

Exclusion criteria

  • cT4b;
  • Perforated disease;
  • Acute obstruction;
  • Emergency operation;
  • Appendiceal cancer;
  • Other primary malignancy treated within 5 years from diagnosis of colon cancer, except for curatively treated prostate, breast, skin and cervical cancer.

Treatment and study plan

Implementation standardised laparoscopic right hemicolectomy with proctoring

Procedure

Implementation standardised laparoscopic right hemicolectomy with proctoring

Implementation standardised laparoscopic right hemicolectomy without proctoring

Procedure

Implementation standardised laparoscopic right hemicolectomy without proctoring

Primary outcomes

  1. 30-day morbidity with Clavien-Dindo grading

    Time frame: 30 days

Secondary outcomes

  1. Intraoperative complications (i.e. vascular injury)

    Time frame: 1 day

  2. Conversion rate from laparoscopic to open surgery

    Time frame: 1 day

  3. Operative time

    Time frame: 1 day

  4. Blood loss

    Time frame: 1 day

  5. Validated assessment of plane of dissection

    Time frame: 1 day

    Assessment according to a competency assessment tool (CAT) for laparoscopic right hemicolectomy. This tool will be created during phase 2 using the Delphi method.

  6. Validated assessment of level of vascular ligation

    Time frame: 1 day

    Assessment according to a competency assessment tool (CAT) for laparoscopic right hemicolectomy. This tool will be created during phase 2 using the Delphi method.

  7. Grading of the resection specimen according to Benz et al. 2019

    Time frame: 1 day

  8. Total lymph node count

    Time frame: 1 day

  9. Number of resected positive lymph nodes

    Time frame: 1 day

  10. Resection margins

    Time frame: 1 day

    Radicality of resection margin of the specimen, as assessed by the pathologist.

  11. Completeness of mesocolic excision based on postoperative CT imaging

    Time frame: 1 day

  12. Locoregional recurrence

    Time frame: 3 years

  13. Distant metastasis

    Time frame: 3 years

  14. 3-year disease free survival (DFS)

    Time frame: 3 years

  15. 5-year overall survival (OS)

    Time frame: 5 years

  16. Long term morbidity: incisional hernia, adhesion related small bowel obstruction, readmissions, reinterventions

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • C.A. Bertelsen, Hillerød University Hospital, Copenhagen, Denmark
  • D. Miskovic, St Marks hospital London, UK
  • Dr. A.W.H. van de Ven
  • Dr. B.R. Toorenvliet, colorectal surgeon
  • Dr. C. Hoff
  • Dr. C. Sietses
  • Dr. F. den Boer
  • Dr. G. D. Slooter
  • Dr. H.L. van Westreenen
  • Dr. J.W.A. Leijtens
  • Dr. O. van Ruler
  • Dr. P. van Duijvendijk
  • Dr. S. van Aalten
  • Dr. U.K. Coblijn
  • Drs. A.A.J. Grüter
  • F. Aigner, Krankenhaus der Barmherzigen Bruder, Graz, Austria
  • Prof. dr. E.C.J. Consten
  • Prof. dr. G.J. Kleinrensink
  • Prof. dr. J. Lange
  • Prof. dr. P.J. Tanis, colorectal surgeon
  • S. Benz, Klinikverbund SuedWest, Böblingen, Germany

Registry information

Official study title

Implementation of Optimized and Standardized Surgical Technique for Right Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study With a Transition Period

Acronym: Right

Important dates

Study start
2021
Primary completion
2022
Study completion
2027
First posted
May 17, 2021
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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