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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Training; Implementation; Assessment; Consolidation; Colonic Carcinoma; Laparoscopic Right Hemicolectomy; Standardisation; Delphi Study
• Intervention / Treatment: Procedure: Implementation standardised laparoscopic right hemicolectomy with proctoring; Procedure: Implementation standardised laparoscopic right hemicolectomy without proctoring

Detailed Description

1. Prospective mapping of current practice with surgical variations in laparoscopic right hemicolectomy (total duration of inclusion 3 months) N= 40 centers N = 310 videos

   1. METC approval for the use of anonymized videos of a laparoscopic procedure and collection of corresponding clinical outcomes.
   2. Approaching hospitals for participation (high volume centers (50+ colon cancers).
   3. Prospective inclusion of consecutive patients undergoing laparoscopic right hemicolectomy in the participating hospitals in three months.

2. Development of Standard Laparoscopic Right Hemicolectomy: an (inter)national Delphi study

   1. Approaching specialists to participate in the Delphi method (from participating hospitals in step 1).
   2. Identification of crucial steps and measures according to literature and expert's opinion (Delphi method).
   3. Documentation of steps and the order in which they need to be performed, development of a competency assessment tool (CAT).

3. Skills center training facility

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

4. 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)

   1. Rating videos.
   2. Comparing with pre-implementation performance based on outcome measures reflecting oncological quality of surgery, and 30-day clinical outcomes.
   3. Comparing with pre-implementation performance based on the long-term outcomes. (3-year DFS and 5-year OS).

5. Implementing standardised lap right hemicolectomy (after learning curve without proctoring)

   1. Consecutive inclusion of patients (n=310)
   2. CT imaging
   3. Video analysis
   4. Competency analysis
   5. Variation analysis
   6. Clinico pathological data

• Study Type: Interventional
• Enrollment (Anticipated): 930
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • Amsterdam Umc, Location Vumc
      • Contact: Alexander A.J. Grüter, MD; Phone Number: +316 45552015; Email: alexandergruter@hotmail.com
      • Contact: Usha K. Coblijn, MD, PhD; Phone Number: +316 43469794; Email: usha.coblijn@gmail.com
      • Principal Investigator: Jurriaan B. Tuynman, MD, PhD
      • Principal Investigator: Pieter J. Tanis, MD, PhD, Prof
      • Principal Investigator: Boudewijn R. Toorenvliet, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Surgical variations laparoscopic right hemicolectomy
Active Comparator: Implementing standardised laparoscopic right hemicolectomy with proctoring	Procedure: Implementation standardised laparoscopic right hemicolectomy with proctoring; Implementation standardised laparoscopic right hemicolectomy with proctoring
Active Comparator: Implementing standardised laparoscopic right hemicolectomy without proctoring	Procedure: Implementation standardised laparoscopic right hemicolectomy without proctoring; Implementation standardised laparoscopic right hemicolectomy without proctoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day morbidity with Clavien-Dindo grading	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time		1 day
Intraoperative complications (i.e. vascular injury)		1 day
Conversion rate from laparoscopic to open surgery		1 day
Blood loss		1 day
Validated assessment of plane of dissection	Assessment according to a competency assessment tool (CAT) for laparoscopic right hemicolectomy. This tool will be created during phase 2 using the Delphi method.	1 day
Validated assessment of level of vascular ligation	Assessment according to a competency assessment tool (CAT) for laparoscopic right hemicolectomy. This tool will be created during phase 2 using the Delphi method.	1 day
Grading of the resection specimen according to Benz et al. 2019		1 day
Total lymph node count		1 day
Number of resected positive lymph nodes		1 day
Resection margins	Radicality of resection margin of the specimen, as assessed by the pathologist.	1 day
Completeness of mesocolic excision based on postoperative CT imaging		1 day
Locoregional recurrence		3 years
Distant metastasis		3 years
3-year disease free survival (DFS)		3 years
5-year overall survival (OS)		5 years
Long term morbidity: incisional hernia, adhesion related small bowel obstruction, readmissions, reinterventions		3 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2027

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 2021.0273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No