Standardizing Right Hemicolectomy for Colon Cancer

Not Applicable

Not yet recruiting

• Conditions: Standardisation; Implementation; Consolidation; Colonic Carcinoma; Laparoscopic Right Hemicolectomy; Training; Delphi Study; Assessment
• Interventions: Procedure: Implementation standardised laparoscopic right hemicolectomy with proctoring; Procedure: Implementation standardised laparoscopic right hemicolectomy without proctoring

• Registration Number: NCT04889456
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

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 Timeline

• Study First Submitted: 2021-04-30
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Study First Posted: 2021-05-17
• Last Update Posted: 2021-05-17
• Study Start: 2021-07-01
• Primary Completion: 2022-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 930

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Implementing standardised laparoscopic right hemicolectomy with proctoring	Implementation standardised laparoscopic right hemicolectomy with proctoring	-
Implementing standardised laparoscopic right hemicolectomy without proctoring	Implementation standardised laparoscopic right hemicolectomy without proctoring	-

Primary Outcome Measures

Name	Time	Method
30-day morbidity with Clavien-Dindo grading	30 days

Secondary Outcome Measures

Name	Time	Method
Conversion rate from laparoscopic to open surgery	1 day
Grading of the resection specimen according to Benz et al. 2019	1 day
3-year disease free survival (DFS)	3 years
Intraoperative complications (i.e. vascular injury)	1 day
Operative time	1 day
Validated assessment of plane of dissection	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.
Resection margins	1 day	Radicality of resection margin of the specimen, as assessed by the pathologist.
Completeness of mesocolic excision based on postoperative CT imaging	1 day
Distant metastasis	3 years
Long term morbidity: incisional hernia, adhesion related small bowel obstruction, readmissions, reinterventions	3 years
Validated assessment of level of vascular ligation	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.
Number of resected positive lymph nodes	1 day
Locoregional recurrence	3 years
Blood loss	1 day
5-year overall survival (OS)	5 years
Total lymph node count	1 day

Trial Locations

Locations (1)

Amsterdam UMC, location VUmc; 🇳🇱 Amsterdam, Noord-Holland, Netherlands