NCT04889456Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 17 May 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 930 (estimated)
- First submitted
- 30 Apr 2021
- Start date
- 1 Jul 2021
- Primary completion date
- 1 Jul 2022
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Colorectal cancer
- NCT number
- NCT04889456
What you commit to
- Study type: Interventional
- Planned participants: 930
- From 1 Jul 2021 to the primary completion date, 1 Jul 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Perforated disease;
- Appendiceal cancer;
- Other primary malignancy treated within 5 years from diagnosis of colon cancer, except for curatively treated prostate, breast, skin and cervical cancer.
Other
- cT4b;
- Acute obstruction;
- Emergency operation;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC location VUmc Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.