Standardizing Right Hemicolectomy for Colon Cancer
Right
Implementation of Optimized and Standardized Surgical Technique for Right Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study With a Transition Period
1 other identifier
interventional
930
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2021
CompletedFirst Posted
Study publicly available on registry
May 17, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
ExpectedMay 17, 2021
May 1, 2021
1 year
April 30, 2021
May 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
30-day morbidity with Clavien-Dindo grading
30 days
Secondary Outcomes (16)
Intraoperative complications (i.e. vascular injury)
1 day
Conversion rate from laparoscopic to open surgery
1 day
Operative time
1 day
Blood loss
1 day
Validated assessment of plane of dissection
1 day
- +11 more secondary outcomes
Study Arms (3)
Surgical variations laparoscopic right hemicolectomy
NO INTERVENTIONImplementing standardised laparoscopic right hemicolectomy with proctoring
ACTIVE COMPARATORImplementing standardised laparoscopic right hemicolectomy without proctoring
ACTIVE COMPARATORInterventions
Implementation standardised laparoscopic right hemicolectomy with proctoring
Implementation standardised laparoscopic right hemicolectomy without proctoring
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amsterdam UMC, location VUmclead
- Prof. dr. P.J. Tanis, colorectal surgeoncollaborator
- Dr. B.R. Toorenvliet, colorectal surgeoncollaborator
- D. Miskovic, St Marks hospital London, UKcollaborator
- S. Benz, Klinikverbund SuedWest, Böblingen, Germanycollaborator
- F. Aigner, Krankenhaus der Barmherzigen Bruder, Graz, Austriacollaborator
- C.A. Bertelsen, Hillerød University Hospital, Copenhagen, Denmarkcollaborator
- Drs. A.A.J. Grütercollaborator
- Dr. U.K. Coblijncollaborator
- Dr. H.L. van Westreenencollaborator
- Dr. C. Sietsescollaborator
- Prof. dr. E.C.J. Constencollaborator
- Dr. A.W.H. van de Vencollaborator
- Dr. P. van Duijvendijkcollaborator
- Dr. S. van Aaltencollaborator
- Dr. F. den Boercollaborator
- Dr. J.W.A. Leijtenscollaborator
- Dr. C. Hoffcollaborator
- Dr. O. van Rulercollaborator
- Dr. G. D. Slootercollaborator
- Prof. dr. J. Langecollaborator
- Prof. dr. G.J. Kleinrensinkcollaborator
Study Sites (1)
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081 HV, Netherlands
Related Publications (1)
Gruter AAJ, Coblijn UK, Toorenvliet BR, Tanis PJ, Tuynman JB; Right Collaborators Group. National implementation of an optimal standardised technique for right-sided colon cancer: protocol of an interventional sequential cohort study (Right study). Tech Coloproctol. 2023 Nov;27(11):1083-1090. doi: 10.1007/s10151-023-02801-6. Epub 2023 Apr 25.
PMID: 37097330DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
April 30, 2021
First Posted
May 17, 2021
Study Start
July 1, 2021
Primary Completion
July 1, 2022
Study Completion (Estimated)
July 1, 2027
Last Updated
May 17, 2021
Record last verified: 2021-05