Status:
RECRUITING
Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer
Lead Sponsor:
University of Turin, Italy
Collaborating Sponsors:
Federico II University
Agnelli Hospital, Italy
Conditions:
Colon Cancer
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.
Detailed Description
This study aims to compare the Complete Mesocolic Excision With Central Vascular Ligation (CME+CVL) with the standard (non-CME) right hemicolectomy in patients with right or proximal transverse colon ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT04871399
Start Date
July 13 2020
End Date
January 1 2027
Last Update
November 14 2022
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale della Misericordia
Grosseto, Arezzo, Italy, 52100
2
Ospedale Città di Sesto San Giovanni
Sesto San Giovanni, Milano, Italy, 20099
3
S. Andrea Hospital
La Spezia, Spezia, Italy, 19121
4
Candiolo Cancer Institute - IRCCS
Candiolo, Torino, Italy, 10060