An interventional study of Implementation standardised laparoscopic right hemicolectomy with proctoring and Implementation standardised laparoscopic right hemicolectomy without proctoring in Colonic Carcinoma, Laparoscopic Right Hemicolectomy and Standardisation, sponsored by Amsterdam UMC, location VUmc. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-17.
Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Treatment
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)
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 930 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Implementation standardised laparoscopic right hemicolectomy with proctoring
Procedure: Implementation standardised laparoscopic right hemicolectomy without proctoring
Implementation standardised laparoscopic right hemicolectomy with proctoring
Implementation standardised laparoscopic right hemicolectomy without proctoring
30-day morbidity with Clavien-Dindo grading
Time frame: 30 days
Intraoperative complications (i.e. vascular injury)
Time frame: 1 day
Conversion rate from laparoscopic to open surgery
Time frame: 1 day
Operative time
Time frame: 1 day
Blood loss
Time frame: 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.
Time frame: 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.
Time frame: 1 day
Grading of the resection specimen according to Benz et al. 2019
Time frame: 1 day
Total lymph node count
Time frame: 1 day
Number of resected positive lymph nodes
Time frame: 1 day
Resection margins
Radicality of resection margin of the specimen, as assessed by the pathologist.
Time frame: 1 day
Completeness of mesocolic excision based on postoperative CT imaging
Time frame: 1 day
Locoregional recurrence
Time frame: 3 years
Distant metastasis
Time frame: 3 years
3-year disease free survival (DFS)
Time frame: 3 years
5-year overall survival (OS)
Time frame: 5 years
Long term morbidity: incisional hernia, adhesion related small bowel obstruction, readmissions, reinterventions
Time frame: 3 years
Plan to share: Undecided
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This study is not yet recruiting, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Amsterdam UMC, location VUmc