Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Federico II University | OTHER |
| Agnelli Hospital, Italy | OTHER |
| Ospedale della Misericordia | OTHER |
| Candiolo Cancer Institute - IRCCS |
Not provided
Not provided
Not provided
Not provided
An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Right hemicolectomy (Non-CME) | Active Comparator | Patients will undergo conventional non-CME procedure. |
|
| Right hemicolectomy with CME+CVL | Experimental | Patients will undergo Right hemicolectomy CME+CVL procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Right hemicolectomy (Non-CME) | Procedure | Transecting the Ileocolic Vein and Artery close to the Superior Mesenteric Vessels without clearing the superior mesenteric vein (SMV) from the adipose tissue. Transecting the Right Colic Vein and Artery and superior right colic vein (when present) peripherally. Transecting the Right branches of the Middle Colic Vein (MCV) and the Middle Colic Artery (MCA) peripherally, without clearing the main trunk of the MCV and the MCA. The Right Gastroepiploic Vein and artery are never transacted. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival at 3 years | The length of time after surgery without any signs or symptoms of local or distant recurrence. | 3 Years. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety-Operative time. | Total time from incision to skin closure expressed in minutes. | Intraoperative |
| Safety-Intraoperative blood loss. | Defined by the volume drained in cm2 into aspiration systems and weight of gauzes, calculated, subtracting the weight of the dry gauzes and volume of saline solution used for irrigation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario Solej, MD | Contact | 00393388624939 | mariosolej@gmail.com | |
| Hogla Aridai Resendiz Aguilar, MD | Contact | 00393512338942 | hogla.resendizagu@edu.unito.it |
| Name | Affiliation | Role |
|---|---|---|
| Maurizio Degiuli, Professor | University of Turin, Department of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale della Misericordia | Not yet recruiting | Grosseto | Arezzo | 52100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28157065 | Background | Bertelsen CA. Complete mesocolic excision an assessment of feasibility and outcome. Dan Med J. 2017 Feb;64(2):B5334. | |
| 30207593 | Background | Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2020 |
Not provided
| OTHER |
| Maggiore Bellaria Hospital, Bologna | OTHER |
| Università degli Studi di Ferrara | OTHER |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
| Azienda Ospedaliera Universitaria Policlinico "G. Martino" | OTHER |
| Ospedale Policlinico San Martino | OTHER |
| University of Rome Tor Vergata | OTHER |
| S. Andrea Hospital | OTHER |
| European Institute of Oncology | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Right hemicolectomy with CME+CVL | Procedure | Separation of the visceral fascia from the parietal fascia by sharp dissection leaving intact mesocolon coverage. Transecting the supplying vessels at their origin from the main vessels, particularly:
The SMV should be cleared from all adipose tissue all along its anterior surface until its intrapancreatic entrance. |
|
| Intraoperative |
| Safety-Intraoperative blood transfusion. | Defined as the number of red blood cells, platelets, or plasma units transfused during the intraoperative time. | Intraoperative |
| Safety- Intraoperative Complications. | Defined as any deviation from the ideal intraoperative course occurring during the operative time, Using the Classification of Intraoperative Complications(CLASSIC). | Intraoperative |
| Early postoperative complications. | Number of patients with any deviation from the normal postoperative course grading by The Clavien-Dindo classification. | 30 postoperative days. |
| Late postoperative complications. | The number of patients with any deviation from the normal postoperative course grading by The Clavien-Dindo classification. | From the 31st postoperative days to the end of the study. |
| Safety- Length of stay. | Defined as the length of an inpatient episode of care, calculated from the day of operation to the first discharge and based on the number of nights spent in the hospital. | 30 Days. |
| Safety- Postoperative mortality rate. | The all-cause death rate, within 30 days after surgery in or out of the hospital. | 30 Days. |
| Overall Survival at 3 years | Defined as the time from random assignment to the date of death due to any cause. | 3 Years. |
| Overall Survival at 5 years. | Defined as the time from random assignment to the date of death due to any cause. | 5 Years. |
| Disease-free survival. | Defined as the length of time after Surgical treatment (CME+CVL or Conventional non-CME procedure) that the patient survives without any signs or symptoms of colon cancer. | 5 Years. |
| Other Oncologic outcomes. | The number of positive, negative, and total lymph nodes harvested, Quality of surgery specimen, quality of life by EORTC specific Questionnaires | 30 Days. |
| Ospedale Città di Sesto San Giovanni | Not yet recruiting | Sesto San Giovanni | Milano | 20099 | Italy |
|
| S. Andrea Hospital | Not yet recruiting | La Spezia | Spezia | 19121 | Italy |
|
| Candiolo Cancer Institute - IRCCS | Not yet recruiting | Candiolo | Torino | 10060 | Italy |
|
| Ospedale E. Agnelli Pinerolo | Not yet recruiting | Pinerolo | Torino | 10064 | Italy |
|
| Maggiore Bellaria Hospital, Bologna | Not yet recruiting | Bologna | 40124 | Italy |
|
| Università degli Studi di Ferrara | Not yet recruiting | Ferrara | 44121 | Italy |
|
| Ospedale Policlinico San Martino | Not yet recruiting | Genova | 16132 | Italy |
|
| Azienda Ospedaliera Universitaria Policlinico "G. Martino" | Not yet recruiting | Messina | 98124 | Italy |
|
| European Institute of Oncology | Not yet recruiting | Milan | 20141 | Italy |
|
| Federico II University | Not yet recruiting | Naples | 80138 | Italy |
|
| University of Rome Tor Vergata | Not yet recruiting | Rome | 00133 | Italy |
|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Not yet recruiting | Rome | 00168 | Italy |
|
| University of Turin (AOU.San Luigi Gonzaga) | Recruiting | Torino | 10043 | Italy |
|
| 30838463 | Background | Benz S, Tannapfel A, Tam Y, Grunenwald A, Vollmer S, Stricker I. Proposal of a new classification system for complete mesocolic excison in right-sided colon cancer. Tech Coloproctol. 2019 Mar;23(3):251-257. doi: 10.1007/s10151-019-01949-4. Epub 2019 Mar 5. |
| 16877723 | Background | Johnson PM, Porter GA, Ricciardi R, Baxter NN. Increasing negative lymph node count is independently associated with improved long-term survival in stage IIIB and IIIC colon cancer. J Clin Oncol. 2006 Aug 1;24(22):3570-5. doi: 10.1200/JCO.2006.06.8866. |
| 23982425 | Background | Galizia G, Lieto E, De Vita F, Ferraraccio F, Zamboli A, Mabilia A, Auricchio A, Castellano P, Napolitano V, Orditura M. Is complete mesocolic excision with central vascular ligation safe and effective in the surgical treatment of right-sided colon cancers? A prospective study. Int J Colorectal Dis. 2014 Jan;29(1):89-97. doi: 10.1007/s00384-013-1766-x. Epub 2013 Aug 28. |
| 22473170 | Background | West NP, Kobayashi H, Takahashi K, Perrakis A, Weber K, Hohenberger W, Sugihara K, Quirke P. Understanding optimal colonic cancer surgery: comparison of Japanese D3 resection and European complete mesocolic excision with central vascular ligation. J Clin Oncol. 2012 May 20;30(15):1763-9. doi: 10.1200/JCO.2011.38.3992. Epub 2012 Apr 2. |
| 20969719 | Background | Bertelsen CA, Bols B, Ingeholm P, Jansen JE, Neuenschwander AU, Vilandt J. Can the quality of colonic surgery be improved by standardization of surgical technique with complete mesocolic excision? Colorectal Dis. 2011 Oct;13(10):1123-9. doi: 10.1111/j.1463-1318.2010.02474.x. |
| 27566031 | Background | Kim NK, Kim YW, Han YD, Cho MS, Hur H, Min BS, Lee KY. Complete mesocolic excision and central vascular ligation for colon cancer: Principle, anatomy, surgical technique, and outcomes. Surg Oncol. 2016 Sep;25(3):252-62. doi: 10.1016/j.suronc.2016.05.009. Epub 2016 May 20. |
| 38087139 | Derived | Degiuli M, Aguilar AHR, Solej M, Azzolina D, Marchiori G, Corcione F, Bracale U, Peltrini R, Di Nuzzo MM, Baldazzi G, Cassini D, Sica GS, Pirozzi B, Muratore A, Calabro M, Jovine E, Lombardi R, Anania G, Chiozza M, Petz W, Pizzini P, Persiani R, Biondi A, Reddavid R. A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial). Ann Surg Oncol. 2024 Mar;31(3):1671-1680. doi: 10.1245/s10434-023-14664-0. Epub 2023 Dec 12. |
| Apr 28, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided