Training Clinical Trial
— RightOfficial title:
Implementation of Optimized and Standardized Surgical Technique for Right Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study With a Transition Period
Verified date | May 2021 |
Source | VU University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC, location VUmc | Amsterdam | Noord-Holland |
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 |
Netherlands,
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 |
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