Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer
- Conditions
- Colon Cancer
- Interventions
- Procedure: Conventional Right hemicolectomy (Non-CME)Procedure: Right hemicolectomy with CME+CVL
- Registration Number
- NCT04871399
- Lead Sponsor
- University of Turin, Italy
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 416
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Right hemicolectomy (Non-CME) Conventional Right hemicolectomy (Non-CME) Patients will undergo conventional non-CME procedure. Right hemicolectomy with CME+CVL Right hemicolectomy with CME+CVL Patients will undergo Right hemicolectomy CME+CVL procedure.
- Primary Outcome Measures
Name Time Method Disease-free survival at 3 years 3 Years. The length of time after surgery without any signs or symptoms of local or distant recurrence.
- Secondary Outcome Measures
Name Time Method Safety-Operative time. Intraoperative Total time from incision to skin closure expressed in minutes.
Early postoperative complications. 30 postoperative days. Number of patients with any deviation from the normal postoperative course grading by The Clavien-Dindo classification.
Overall Survival at 5 years. 5 Years. Defined as the time from random assignment to the date of death due to any cause.
Overall Survival at 3 years 3 Years. Defined as the time from random assignment to the date of death due to any cause.
Disease-free survival. 5 Years. 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.
Safety-Intraoperative blood loss. Intraoperative 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.
Late postoperative complications. From the 31st postoperative days to the end of the study. The number of patients with any deviation from the normal postoperative course grading by The Clavien-Dindo classification.
Safety- Length of stay. 30 Days. 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.
Safety- Postoperative mortality rate. 30 Days. The all-cause death rate, within 30 days after surgery in or out of the hospital.
Safety-Intraoperative blood transfusion. Intraoperative Defined as the number of red blood cells, platelets, or plasma units transfused during the intraoperative time.
Safety- Intraoperative Complications. Intraoperative Defined as any deviation from the ideal intraoperative course occurring during the operative time, Using the Classification of Intraoperative Complications(CLASSIC).
Other Oncologic outcomes. 30 Days. The number of positive, negative, and total lymph nodes harvested, Quality of surgery specimen, quality of life by EORTC specific Questionnaires
Trial Locations
- Locations (14)
Università degli Studi di Ferrara
🇮🇹Ferrara, Italy
European Institute of Oncology
🇮🇹Milano, Italy
University of Rome Tor Vergata
🇮🇹Rome, Italy
Ospedale Città di Sesto San Giovanni
🇮🇹Sesto San Giovanni, Milano, Italy
Ospedale della Misericordia
🇮🇹Grosseto, Arezzo, Italy
Candiolo Cancer Institute - IRCCS
🇮🇹Candiolo, Torino, Italy
Ospedale E. Agnelli Pinerolo
🇮🇹Pinerolo, Torino, Italy
S. Andrea Hospital
🇮🇹La Spezia, Spezia, Italy
Maggiore Bellaria Hospital, Bologna
🇮🇹Bologna, Italy
Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
🇮🇹Messina, Italy
Federico II University
🇮🇹Napoli, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Rome, Italy
University of Turin (AOU.San Luigi Gonzaga)
🇮🇹Torino, Italy