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Standardizing Right Hemicolectomy for Colon Cancer

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04889456
Acronym
Right
Enrollment
930
Registered
2021-05-17
Start date
2021-07-01
Completion date
2027-07-01
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assessment, Colonic Carcinoma, Consolidation, Delphi Study, Implementation, Laparoscopic Right Hemicolectomy, Standardisation, Training

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

Interventions

PROCEDUREImplementation standardised laparoscopic right hemicolectomy with proctoring

Implementation standardised laparoscopic right hemicolectomy with proctoring

PROCEDUREImplementation standardised laparoscopic right hemicolectomy without proctoring

Implementation standardised laparoscopic right hemicolectomy without proctoring

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A prospective interventional sequential cohort study with a transition period

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
30-day morbidity with Clavien-Dindo grading30 days

Secondary

MeasureTime frameDescription
Conversion rate from laparoscopic to open surgery1 day
Operative time1 day
Blood loss1 day
Validated assessment of plane of dissection1 dayAssessment according to a competency assessment tool (CAT) for laparoscopic right hemicolectomy. This tool will be created during phase 2 using the Delphi method.
Validated assessment of level of vascular ligation1 dayAssessment according to a competency assessment tool (CAT) for laparoscopic right hemicolectomy. This tool will be created during phase 2 using the Delphi method.
Grading of the resection specimen according to Benz et al. 20191 day
Total lymph node count1 day
Intraoperative complications (i.e. vascular injury)1 day
Resection margins1 dayRadicality of resection margin of the specimen, as assessed by the pathologist.
Completeness of mesocolic excision based on postoperative CT imaging1 day
Locoregional recurrence3 years
Distant metastasis3 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, reinterventions3 years
Number of resected positive lymph nodes1 day

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026