Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer (CoME-In)

University of Turin

Status

Enrolling

Conditions

Colon Cancer

Treatments

Procedure: Right hemicolectomy with CME+CVL

Procedure: Conventional Right hemicolectomy (Non-CME)

Study type

Interventional

Funder types

Other

Identifiers

NCT04871399

N.110/2019/U

Details and patient eligibility

About

An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.

Full 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 cancer stage II-IV(AJCC 8th edition) to determine the short and long term outcomes in terms of disease-free survival (DFS) as a primary endpoint, and safety, oncologic outcomes, quality of surgery and quality of life (QoL) as secondary endpoints.

Eligible patients will be randomized with a 1:1 ratio between CME + CVL vs standard non-CME right colectomy. The randomization sequence will be generated centrally by a computed algorithm and kept concealed to investigators.

The Right colectomy with CME + CVL includes the removal of the accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Despite the surgical approach and the type of procedure adopted, the operation should be strictly conducted following the general rules for colorectal oncologic resection, particularly as concerns proximal and distal margins length and lymph node retrieval.

All surgical approaches (open, laparoscopic, or robotic) will be allowed while the type of anastomosis performed and drain placement will be up to the surgeon's discretion.

Demographic, baseline, perioperative and postoperative characteristics will be analyzed as well.

The study expected to last six and a half years, of which one and a half years for recruiting 416 patients, 208 each arm, with five years of follow-up. Patients will be followed up at 1, 4, 12, 24, 36, and 60 months postoperatively.

Enrollment

416 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.