Plain English Summary
Background and study aims
A hemicolectomy is a surgical procedure that involves removing a segment of the colon, for example to treat colon cancer. The aim of this study is to compare the short-term outcomes of patients who undergo laparoscopic (keyhole surgery) right hemicolectomy using the CME and CVL technique (CME group) with patients who undergo conventional right-sided colonic resection (Not Complete Mesocolic Excision, NCME group).
Who can participate?
Patients with right-sided colon cancer who are undergoing laparoscopic colonic resection (removal of the part of the colon containing the cancer)
What does the study involve?
Participants are randomly allocated to undergo laparoscopic complete mesocolic excision with central vascular ligation (CME group) or laparoscopic standard right hemicolectomy (Not Complete Mesocolic Excision, NCME group). Both groups are followed up during their hospital stay or 30 days and long term to obtain results about ontological (cancer) outcomes.
What are the possible benefits and risks of participating?
Possible benefits include better surgical outcomes in the CME group. Possible risks include a higher rate of complications in the CME group than the NCME group.
Where is the study run from?
1. University Hospital Policlinico "P. Giaccone" of Palermo (Italy)
2. University of Palermo (Italy)
When is the study starting and how long is it expected to run for?
October 2014 to December 2022
Who is funding the study?
University of Palermo (Italy)
Who is the main contact?
1. Prof. Agrusa Antonino
2. Dr Giuseppe Di Buono
Feasibility and safety of laparoscopic complete mesocolic excision (CME) for right-sided colon cancer: a prospective clinical study
Laparoscopic complete mesocolic excision (CME) provides better surgical specimens than standard laparoscopic hemicolectomy.
Not provided at time of registration
Interventional single-centre study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Right-sided colon cancer
Method of randomisation: cluster randomisation:
CME group (cases): laparoscopic complete mesocolic excision and central vascular ligation
NCME group (controls): standard laparoscopic right hemicolectomy
Follow-up: variable from short-term follow-up during hospital stay or 30-days in order to obtain feasibility and safety of laparoscopic CME versus NCME; long-term follow-up in order to obtain results about oncological outcomes.
Primary outcome measure
1. Operative time (skin-to-skin) in minutes, measured from medical records at the time of surgery
2. Intraoperative blood loss in mL, measured from medical records at the time of surgery
3. Other intraoperative complications: YES or NO and type of intraoperative complications (categorical variable), measured from medical records at the time of surgery
4. Conversion rate: YES or NO and percentage, measured from medical records at the time of surgery
5. Anastomotic leakage rate: YES or NO and percentage, measured from medical records during hospital stay
6. Specimen length: length in cm of surgical specimen, from histologic examination during 30 days
7. Lymph nodes harvesting: number of lymph nodes in surgical specimen, from histologic examination during 30 days
Secondary outcome measures
Postoperative overall complications: YES or NO and type of postoperative complications (categorical variable), measured from medical records and radiologic imaging during hospital stay or 30 days
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Patients with right-sided colon cancer
Target number of participants
Total final enrolment
Participant exclusion criteria
Open surgery, right colon resections for inflammatory bowel diseases (IBD) and associated major surgical procedures
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
General and Emergency Surgery - University Hospital Policlinico "P. Giaccone"
via L. Giuffrè, 5
Università degli Studi di Palermo
Palermo University, University of Palermo
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)