Standardizing Right Hemicolectomy for Colon Cancer

Training Clinical Trial

— Right  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04889456
• Other study ID #: 2021.0273
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 1, 2027

Study information

• Verified date: May 2021
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 930
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Assessment
• Colonic Carcinoma
• Colonic Neoplasms
• Consolidation
• Implementation
• Training

Intervention

Procedure:
• Implementation standardised laparoscopic right hemicolectomy with proctoring
Implementation standardised laparoscopic right hemicolectomy with proctoring
• Implementation standardised laparoscopic right hemicolectomy without proctoring
Implementation standardised laparoscopic right hemicolectomy without proctoring

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location VUmc	Amsterdam	Noord-Holland

Sponsors (22)

Lead Sponsor

Collaborator

VU University Medical Center

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day morbidity with Clavien-Dindo grading		30 days
Secondary	Intraoperative complications (i.e. vascular injury)		1 day
Secondary	Conversion rate from laparoscopic to open surgery		1 day
Secondary	Operative time		1 day
Secondary	Blood loss		1 day
Secondary	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
Secondary	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
Secondary	Grading of the resection specimen according to Benz et al. 2019		1 day
Secondary	Total lymph node count		1 day
Secondary	Number of resected positive lymph nodes		1 day
Secondary	Resection margins	Radicality of resection margin of the specimen, as assessed by the pathologist.	1 day
Secondary	Completeness of mesocolic excision based on postoperative CT imaging		1 day
Secondary	Locoregional recurrence		3 years
Secondary	Distant metastasis		3 years
Secondary	3-year disease free survival (DFS)		3 years
Secondary	5-year overall survival (OS)		5 years
Secondary	Long term morbidity: incisional hernia, adhesion related small bowel obstruction, readmissions, reinterventions		3 years