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| Name | Class |
|---|---|
| Prof. dr. P.J. Tanis, colorectal surgeon | UNKNOWN |
| Dr. B.R. Toorenvliet, colorectal surgeon | UNKNOWN |
| D. Miskovic, St Marks hospital London, UK | UNKNOWN |
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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.
Prospective mapping of current practice with surgical variations in laparoscopic right hemicolectomy (total duration of inclusion 3 months) N= 40 centers N = 310 videos
Development of Standard Laparoscopic Right Hemicolectomy: an (inter)national Delphi study
Skills center training facility
a. Training the participating surgeons in the method of the standardized laparoscopic right hemicolectomy, as consented in the Delphi method.
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)
Implementing standardised lap right hemicolectomy (after learning curve without proctoring)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical variations laparoscopic right hemicolectomy | No Intervention | ||
| Implementing standardised laparoscopic right hemicolectomy with proctoring | Active Comparator |
| |
| Implementing standardised laparoscopic right hemicolectomy without proctoring | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation standardised laparoscopic right hemicolectomy with proctoring | Procedure | Implementation standardised laparoscopic right hemicolectomy with proctoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day morbidity with Clavien-Dindo grading | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complications (i.e. vascular injury) | 1 day | |
| Conversion rate from laparoscopic to open surgery | 1 day | |
| Operative time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, location VUmc | Amsterdam | North Holland | 1081 HV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37097330 | Derived | Gruter AAJ, Coblijn UK, Toorenvliet BR, Tanis PJ, Tuynman JB; Right Collaborators Group. National implementation of an optimal standardised technique for right-sided colon cancer: protocol of an interventional sequential cohort study (Right study). Tech Coloproctol. 2023 Nov;27(11):1083-1090. doi: 10.1007/s10151-023-02801-6. Epub 2023 Apr 25. |
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| S. Benz, Klinikverbund SuedWest, Böblingen, Germany |
| UNKNOWN |
| F. Aigner, Krankenhaus der Barmherzigen Bruder, Graz, Austria | UNKNOWN |
| C.A. Bertelsen, Hillerød University Hospital, Copenhagen, Denmark | UNKNOWN |
| Drs. A.A.J. GrĂ¼ter | UNKNOWN |
| Dr. U.K. Coblijn | UNKNOWN |
| Dr. H.L. van Westreenen | UNKNOWN |
| Dr. C. Sietses | UNKNOWN |
| Prof. dr. E.C.J. Consten | UNKNOWN |
| Dr. A.W.H. van de Ven | UNKNOWN |
| Dr. P. van Duijvendijk | UNKNOWN |
| Dr. S. van Aalten | UNKNOWN |
| Dr. F. den Boer | UNKNOWN |
| Dr. J.W.A. Leijtens | UNKNOWN |
| Dr. C. Hoff | UNKNOWN |
| Dr. O. van Ruler | UNKNOWN |
| Dr. G. D. Slooter | UNKNOWN |
| Prof. dr. J. Lange | UNKNOWN |
| Prof. dr. G.J. Kleinrensink | UNKNOWN |
A prospective interventional sequential cohort study with a transition period
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| Implementation standardised laparoscopic right hemicolectomy without proctoring | Procedure | Implementation standardised laparoscopic right hemicolectomy without proctoring |
|
| 1 day |
| Blood loss | 1 day |
| 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 |
| 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 |
| Grading of the resection specimen according to Benz et al. 2019 | 1 day |
| Total lymph node count | 1 day |
| Number of resected positive lymph nodes | 1 day |
| Resection margins | Radicality of resection margin of the specimen, as assessed by the pathologist. | 1 day |
| Completeness of mesocolic excision based on postoperative CT imaging | 1 day |
| Locoregional recurrence | 3 years |
| Distant metastasis | 3 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, reinterventions | 3 years |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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