Name of the study
Implementation of optimized and standardized surgical technique for right-sided colon cancer: a prospective interventional sequential cohort study with a transition period
Researchers and contact information
Dr. J.B. Tuynman, firstname.lastname@example.org
Prof. dr. P.J. Tanis, email@example.com
Dr. B.R. Toorenvliet, firstname.lastname@example.org
A.A.J. Grüter, email@example.com
Surgical procedures for gastrointestinal oncology intervention are inevitably highly variable amongst surgeons and centers. Although this variation is acceptable to a certain degree, a substantial proportion of this variability has a potential relevance for both short term clinical outcomes and long term oncological survival. For patients with right-sided colon cancer, a laparoscopic right hemicolectomy (LRHC) is the surgical procedure of choice to remove the cancer and locoregional lymph nodes. This surgical technique has evolved during the last decade with the introduction of the intracorporeal anastomosis, the Pfannenstiel extraction and the complete mesocolic excision (CME). The latter is a dissection technique in embryological planes with a central vascular ligation of the segmental branches at its origin, resulting in an optimal lymphadenectomy. Given the insights from recent studies showing a positive association between the quality of surgery and relevant clinical outcomes, there is a great need to reduce the interinstitutional and intersurgeon variability and to implement an optimized and standardized surgical technique for right-sided colon cancer in the Netherlands to improve short- and long-term clinical and oncological outcomes. This kind of implementation needs a consensus of the key elements of the procedure and 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 and oncological outcomes for patients 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.
Prospective interventional sequential multicenter cohort study.
Patients with planned laparoscopic or robot-assisted (extended) right hemicolectomy for colon cancer of the caecum, ascending colon or hepatic flexure.
Implementation of the standardized right hemicolectomy with first proctoring and after 365 inclusions without proctoring during a subsequent period with prospective inclusion of consecutive patients and the collection of surgical videos in all participating hospitals.
The primary endpoint is the 90-day morbidity according to the Clavien-Dindo classification system. The design will be a non-inferiority trial to ensure safety during the implementation of a new adapted surgical technique.
Secondary endpoints include 90-day mortality, intraoperative complications (i.e. vascular injury), conversion rate, operative time, blood loss, validated assessment of the dissection plane, validated assessment of the level of vascular ligation, grading of the resection specimen, total lymph node count, number of resected positive lymph nodes, resection margins, completeness of mesocolic excision based on the one year postoperative CT imaging, locoregional recurrence, distant metastasis, three year disease free survival (DFS), five year overall survival (OS) and long term morbidity (incisional hernia, adhesion related small bowel obstruction, readmissions, reinterventions, anastomotic leakage).
Schematic five step approach
- Admiraal de Ruyter Ziekenhuis, Vlissingen
- Albert Schweitzer Ziekenhuis, Dordrecht
- Alrijne Ziekenhuis, Leiderdorp, Leiden, Alphen aan den Rijn
- Amstelland Ziekenhuis, Amstelveen
- Amsterdam UMC, Amsterdam
- Antoni van Leeuwenhoek, Amsterdam
- Beatrixziekenhuis Rivas Zorggroep, Gorinchem
- Bravis Ziekenhuis, Bergen op Zoom/Roosendaal
- Canisius Wilhelmina Ziekenhuis (CWZ), Nijmegen
- Deventer Ziekenhuis, Deventer
- Diakonessenhuis Utrecht, Utrecht
- Dijklander Ziekenhuis, Hoorn/Purmerend
- Elisabeth-TweeSteden Ziekenhuis (ETZ), Tilburg
- Flevoziekenhuis, Almere
- Franciscus Gasthuis Vlietland, Rotterdam
- Gelre Ziekenhuizen, Apeldoorn, Zutphen
- Groene Hart Ziekenhuis, Gouda
- Haaglanden Medisch Centrum, Den Haag
- IJsselland Ziekenhuis, Capelle aan den IJssel
- Ikazia Ziekenhuis, Rotterdam
- Isala Ziekenhuizen, Zwolle, Meppel, Kampen, Steenwijk, Heerde
- LangeLand Ziekenhuis, Zoetermeer
- Laurentius Ziekenhuis, Roermond
- Maastricht Universitair Medisch Centrum, Maastricht
- Maasziekenhuis Pantein, Beugen
- Meander Medisch Centrum, Amersfoort
- Medisch Centrum Leeuwarden, Leeuwarden
- Nij Smellinghe, Drachten
- Onze Lieve Vrouwe Gasthuis, Amsterdam
- Rijnstate Ziekenhuis, Arnhem
- Rode Kruis Ziekenhuis, Beverwijk
- Sint Jansgasthuis, Weert
- Spaarne Gasthuis, Haarlem, Hoofddorp
- Stichting ZorgSaam Zeeuws Vlaanderen, Terneuzen
- St Antonius, Niewegein
- Van Weel-Bethesda Ziekenhuis, Dirksland
- VieCuri Medisch Centrum, Venray
- Zaans Medisch Centrum, Zaandam
- Ziekenhuis Gelderse Vallei, Ede
- Ziekenhuis Groep Twente, Hengelo, Almelo
- Ziekenhuis St Jansdal, Harderwijk
- Zuyderland Medisch Centrum, Heerlen, Sittard-Geleen