Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer
Recruiting · NCT04871399 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Turin, Italy
View the official record on ClinicalTrials.gov →Interventions studied
Conventional Right hemicolectomy (Non-CME)Right hemicolectomy with CME+CVL
What this trial is about
An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- American Society of Anesthesiologists(ASA) grade I-III.
- Right colon cancer (\*The right-sided location of the cancer is defined as the location from the caecum up to the proximal third of the transverse colon), preoperative assessment of tumor stage T2-T4a, any N or T any N+ according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015); no distant metastasis.
- Informed consent
Exclusion criteria
- Age \> 85 years old.
- T1, N0
- T4b, any N
- BMI \> 30.
- Metastatic disease (Abdominal and chest CT scan will be mandatory to exclude distant metastasis.)
- American Society of Anesthesiologists(ASA) grade IV.
- History of cancer in recent 5 years.
- Need for Emergency surgery.
- Infectious disease requiring treatment.
- Pregnancy.
- Use of systemic steroids.
- No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
Where it is running
14 locations listed.
- Maggiore Bellaria Hospital, Bologna - Bologna, Italy
- Università degli Studi di Ferrara - Ferrara, Italy
- Ospedale Policlinico San Martino - Genova, Italy
- Azienda Ospedaliera Universitaria Policlinico "G. Martino" - Messina, Italy
- European Institute of Oncology - Milan, Italy
- Federico II University - Naples, Italy
- University of Rome Tor Vergata - Rome, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Rome, Italy
- University of Turin (AOU.San Luigi Gonzaga) - Torino, Italy
- Ospedale della Misericordia - Grosseto, Arezzo, Italy
- Ospedale Città di Sesto San Giovanni - Sesto San Giovanni, Milano, Italy
- S. Andrea Hospital - La Spezia, Spezia, Italy
- Candiolo Cancer Institute - IRCCS - Candiolo, Torino, Italy
- Ospedale E. Agnelli Pinerolo - Pinerolo, Torino, Italy