Clinical trial NCT04889456: Standardizing Right Hemicolectomy for Colon Cancer
Official title: Implementation of Optimized and Standardized Surgical Technique for Right Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study With a Transition Period
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colonic Carcinoma
Laparoscopic Right Hemicolectomy
Standardisation
Training
Delphi Study
Implementation
Consolidation
Assessment
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Prof. dr. P.J. Tanis, colorectal surgeon
name: Dr. B.R. Toorenvliet, colorectal surgeon
name: D. Miskovic, St Marks hospital London, UK
name: S. Benz, Klinikverbund SuedWest, Böblingen, Germany
name: F. Aigner, Krankenhaus der Barmherzigen Bruder, Graz, Austria
name: C.A. Bertelsen, Hillerød University Hospital, Copenhagen, Denmark
name: Drs. A.A.J. Grüter
name: Dr. U.K. Coblijn
name: Dr. H.L. van Westreenen
name: Dr. C. Sietses
name: Prof. dr. E.C.J. Consten
name: Dr. A.W.H. van de Ven
name: Dr. P. van Duijvendijk
name: Dr. S. van Aalten
name: Dr. F. den Boer
name: Dr. J.W.A. Leijtens
name: Dr. C. Hoff
name: Dr. O. van Ruler
name: Dr. G. D. Slooter
name: Prof. dr. J. Lange
name: Prof. dr. G.J. Kleinrensink
First posted: 2021-05-17
Enrollment: 930
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A prospective interventional sequential cohort study with a transition period
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: 30-day morbidity with Clavien-Dindo grading
timeFrame: 30 days
Secondary outcomes:
measure: Intraoperative complications (i.e. vascular injury)
timeFrame: 1 day
measure: Conversion rate from laparoscopic to open surgery
timeFrame: 1 day
measure: Operative time
timeFrame: 1 day
measure: Blood loss
timeFrame: 1 day
measure: Validated assessment of plane of dissection
timeFrame: 1 day
measure: Validated assessment of level of vascular ligation
timeFrame: 1 day
measure: Grading of the resection specimen according to Benz et al. 2019
timeFrame: 1 day
measure: Total lymph node count
timeFrame: 1 day
measure: Number of resected positive lymph nodes
timeFrame: 1 day
measure: Resection margins
timeFrame: 1 day
measure: Completeness of mesocolic excision based on postoperative CT imaging
timeFrame: 1 day
measure: Locoregional recurrence
timeFrame: 3 years
measure: Distant metastasis
timeFrame: 3 years
measure: 3-year disease free survival (DFS)
timeFrame: 3 years
measure: 5-year overall survival (OS)
timeFrame: 5 years
measure: Long term morbidity: incisional hernia, adhesion related small bowel obstruction, readmissions, reinterventions
timeFrame: 3 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
state: Noord-Holland
Study officials:
References: