Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871399
Status:
RECRUITING
Last Update Posted:
2022-11-14
First Post:
2021-04-23
Brief Title:
Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for the Right Colon Cancer An Italian Randomized Trial
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoME-In
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 CMECVL with the standard non-CME right hemicolectomy in patients with right or proximal transverse colon cancer stage II-IVAJCC 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 11 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 surgeons 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
Eligible patients will be randomized with a 11 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 surgeons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None