Comparison between laparoscopic complete mesocolic excision versus standard laparoscopic colonic resection for right-sided colon cancer

ISRCTN	ISRCTN71842827
DOI	https://doi.org/10.1186/ISRCTN71842827
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	LaCoMEStaR1
Sponsor	Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo
Funder	Università degli Studi di Palermo

Submission date: 30/03/2020
Registration date: 07/04/2020
Last edited: 11/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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
giuseppe.dibuono@unipa.it

Contact information

Dr Giuseppe Di Buono
Scientific

Via L. giuffrè, 5
Palermo
90127
Italy

ORCID ID	0000-0001-9928-6448
Phone	+39 (0)3927667467
Email	giuseppe.dibuono@unipa.it

Study information

Primary study design	Interventional
Study design	Interventional single-centre study
Secondary study design	Randomised controlled trial
Scientific title	Feasibility and safety of laparoscopic complete mesocolic excision (CME) for right-sided colon cancer: a prospective clinical study
Study acronym	LaCoMEStaR
Study objectives	Laparoscopic complete mesocolic excision (CME) provides better surgical specimens than standard laparoscopic hemicolectomy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Right-sided colon cancer
Intervention	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.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Total final enrolment	132
Key inclusion criteria	Patients with right-sided colon cancer
Key exclusion criteria	Open surgery, right colon resections for inflammatory bowel diseases (IBD) and associated major surgical procedures
Date of first enrolment	01/01/2015
Date of final enrolment	31/12/2019

Locations

Countries of recruitment

Italy

Study participating centre

General and Emergency Surgery - University Hospital Policlinico "P. Giaccone"

via L. Giuffrè, 5
Palermo
90127
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2021	11/08/2021	Yes	No

Editorial Notes

11/08/2021: Publication reference added.
06/04/2020: Trial's existence confirmed by University Hospital Policlinico "P. Giaccone" of Palermo.